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79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Secundum Atrial Septal Defects A patient will be eligible for study participation if he/she meets the following 1. Able to fluently speak and understand the language in which the study is being conducted 2. Has ostium secundum atrial septal defect 3. Has a defect hole with a diameter of < 38 mm 4. Has a left-to-right shunt with a Qp/Qs ratio of ≥ 1.5:1 or the presence of right ventricular volume overload determined by transthoracic echo (TTE) or clinical symptoms due to the atrial septal defect 5. Has a distance of > 5 mm from the margins of the defect(s) to the coronary sinus, arterioventricular (AV) valves and right upper pulmonary vein as measured by echocardiography 6. Agrees to participate in the study and comply with the follow-up schedule 7. Is willing to freely give (or Legally Authorized Representative is willing to freely give) Informed Consent prior to treatment 8. Willing to return for the post-treatment evaluation Has multiple defects which can't adequately be covered by the device 2. Has associated congenital cardiac anomalies which require cardiac surgery a. Has a known sensitivity to contrast media that cannot be controlled adequately with pre-medication. 3. Patient is currently participating in another clinical device or drug trial that has not completed its primary endpoint or that will clinically confound the current study endpoints or does not permit subjects to participate in other studies. Typically, subjects that are involved in the long-term surveillance phase of a clinical study are eligible. 4. Has ostium primum atrial septal defects 5. Has sinus venosus atrial septal defects 6. Has partial anomolous pulmonary venous drainage 7. Has pulmonary vascular resistance above 7 Woods units or a right-toleft shunt at the atrial level with a peripheral arterial saturation less than 94% 8. Has a recent myocardial infarction, unstable angina and decompensated congestive heart failure (CHF) 9. Has right and/or left ventricular decompensation with ejection fraction of < 30% 10. Has an active bacterial and/or viral infection 11. Has any type of serious infection < 1 month prior to the procedure 12. Has malignancy where life expectancy is < 2 years 13. Has demonstrated intracardiac thrombi on echocardiography 14. Weighs < 8 kg 15. Has gastritis, gastric ulcer, duodenal ulcer, etc. and other contraindications to aspirin therapy unless other anti-platelet agents can be administered for 6 months 16. Has an unstable condition or otherwise thought to be unreliable or incapable of complying with the requirements of the clinical investigational plan (CIP). 17. Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.083-18.0, Mitral Valve Insufficiency Patients with mitral regurgitation heart disease. 2. Patients with an age range of 1 day years 3. Patients with mitral regurgitation heart disease with atrial septal defects 4. Mitral valve repair surgery performed by single surgeon (Budi Rahmat, MD) Patients refuse to participate in the study. 2. Having additional cardiac abnormalities other than atrial septal defects that change the surgery plan. 3. Reoperation mitral valve surgery. 4. History of abnormalities in the central nervous system / preoperative stroke. 5. Patients with severe pulmonary hypertension 6. Patients with small left ventricles (LV smallish) 7. History of pulmonary resuscitation (CPR) before surgery. Dropout 1. The patient fails to complete the entire examination procedure. 2. Mitral regurgitation patients who are decided to do mitral valve replacement intra-operatively. 3. Using extracorporeal life support (ECMO) device after surgery. 4. History of intra-operative CPR | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Infection Heart Failure Chronic Obstructive Pulmonary Disease Asthma Gout Flare Chronic Kidney Diseases Hypertensive Urgency Atrial Fibrillation Rapid Anticoagulants; Increased Patient clinical >=18 years old Any infectious process (e.g., pneumonia, diverticulitis, cellulitis, complicated urinary tract infection) Heart failure exacerbation Asthma and chronic obstructive pulmonary disease exacerbation Atrial fibrillation with rapid ventricular response Diabetes and its complications Venous thromboembolism: This includes a patient who requires therapeutic anticoagulation and concomitant monitoring (thus requiring inpatient status) Gout exacerbation Chronic kidney disease with volume overload Acute delirium, as determined by the Confusion Assessment Method Cannot establish peripheral access (or access requires ultrasound guidance, unless ultrasound guidance is available) Secondary condition: active non-melanoma/prostate cancer, end-stage renal disease, acute myocardial infarction, acute cerebral vascular accident, acute hemorrhage Primary diagnosis requires controlled substances Cannot independently ambulate to bedside commode As deemed by on-call MD, patient likely to require any of the following procedures that have not already occurred: computed tomography, magnetic resonance imaging, endoscopic procedure, blood transfusion, cardiac stress test, or surgery For pneumonia: Most recent CURB65 > 3: new confusion, BUN > 19mg/dL, respiratory rate>=30/min, systolic blood pressure<90mmHg, Age>=65 (<14% 30-day mortality); Most recent > 2: systolic blood pressure < 90mmHg (2pts), multilobar CXR involvement (1pt), respiratory rate >= 30/min, heart rate >= 125, new confusion, oxygen saturation <= 90% (<10% chance of intensive respiratory or vasopressor support); Absence of clear infiltrate on imaging; Cavitary lesion on imaging; Pulmonary effusion of unknown etiology; O2 saturation < 90% despite 5L O2 For heart failure: Has a left ventricular assist device; GWTG-HF17 (>10% in-hospital mortality) or (high risk or intermediate risk 1)*; Severe pulmonary hypertension For complicated urinary tract infection: Absence of pyuria; Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality) For other infection: Most recent qSOFA > 1 (SBP≤100 mmHg, RR≥22, GCS<15 [any AMS]) (if sepsis, >10% mortality) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Acute Exacerbation of COPD COPD verified by specialist and spirometry Admitted with the diagnosis "acute exacerbation of COPD" TR-gradient ≥40 mmHg verified by specialist and echocardiography Informed consent Known pulmonal hypertension Known heart disease which affects the pump function of the heart Men <40 years Women <55 years Not-menopauseal women <55 years (Menopause is defined as no menstruation within 12 months.) Severe mental illness which significantly complicates cooperation Severe language difficulties which significantly complicates cooperation known allergy to Sildenafil Sildenafil consumption ≥50 mg / week due to other indications | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Acute Pancreatitis Complication Patients diagnosed with acute pancreatitis with clinical, radiological or laboratory criteria All genders Acute pancreatitis of any aetiology Over 18 years old Lung diseases Heart failure Cholangitis Acute cholecystitis Pregnancy Refuse to participate | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Pulmonary Arterial Hypertension Pulmonary Hypertension 18 years or older. 2. Diagnosis of WHO Group 1 PH (Pulmonary Arterial Hypertension, PAH) evidenced by all the following parameters measured at rest: 1. Mean pulmonary artery pressure (mPAP) ≥25 mmHg; 2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg; 3. Pulmonary vascular resistance (PVR) >3 Wood units. 3. Patient remains symptomatic despite being on a stable drug regimen of at least two PH specific medications for at least 90 days prior to planned index procedure. 4. Patient with a current assessment of WHO Functional Class (FC) III. 5. Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT). 6. Patient is deemed appropriate for Aria CV device by the Patient Care Team at the investigation site and approved by the Central Screening Committee (CSC). 7. Patient understands the study requirements, is willing and able to provide appropriate informed consent and is committed and able to attend all required follow-up visits and undergo all required tests at the clinic Diagnosis of WHO PH Groups 2, 3, 4 or 5. 2. Patient with recent clinical events of any of the following: 1. Myocardial infarction or stroke within 6 months prior to the index procedure; 2. Sustained tachyarrhythmia (documented heart rate >110/min) within 2 months prior to the index procedure. 3. Any pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that may interfere with Aria CV device placement or function (e.g. pulmonary or tricuspid valve repair or replacement, pacemaker, defibrillator, inferior vena cava filters, neurostimulators, drug infusion devices, etc.). 4. Patient with any of the following medical history or comorbidities: 1. History of endocarditis; 2. Current renal insufficiency as demonstrated by a serum creatinine > 2.0 mg/dL or end stage renal disease requiring chronic dialysis; 3. Current scleroderma, or other collagen vascular disease treated with immuno-suppressant; 4. Current pulmonary veno-occlusive disease (PVOD); 5. Current pulmonary capillary hemangiomatosis (PCH); 6. History of clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt; 7. History of gastric antral vascular ectasia (GAVE), gastrointestinal or intracranial bleeding which, in the opinion of the investigator, will predispose subject to major bleeding events following Aria CV device placement and warfarin anticoagulation regimen; 8. Current active systemic infection requiring antibiotic therapy; 9. Blood dyscrasias that may, in the opinion of investigator(s), expose patient to unacceptable procedural risks such as severe or worsening leukopenia, anemia, thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or coagulopathy. 5. Anatomy not suitable for placement of Aria CV device, including 1. No suitable subcutaneous implantation location for the reservoir; 2. Contraindication to 22 Fr venous access via a subclavian vein; 3. Body habitus that precludes safe placement of any components of the Aria CV device. 6. Right heart valve regurgitation: 1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation; 2. Severe (Grade 4) tricuspid valve regurgitation. 7. Hypersensitivity or contraindication to 1. Required medications (e.g. contrast agents, warfarin, heparin) which cannot be adequately managed; 2. Materials in device including polyurethane, silicone, nickel, and titanium. 8. Patient ineligible for or refuses blood transfusion. 9. Pregnant or lactating female or planning a pregnancy during participation in the study. 10. Patient with life expectancy of less than two years. 11. Currently participating in or planning to participate in other investigational drug or device trials that may interfere with the outcome of this study | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-99.0, Atrial Septal Aneurysm In large-ASA patients with PFO (Phase1) (1)The length of ASA >20 mm and bulging >10 mm or a combined total excursion right and left > 15 mm; (2)Presence of a PFO indicated for device closure (Echocardiographic and/or transcranial Doppler evidence of right to left shunt at the atrial level); (3)History of cryptogenic stroke/TIA/migraine without other risks; (4) Failure to cover ASA after trial device-closure of PFO and the unstable device confirmed with push-pull test; 2. In large-ASA patients with secundum ASD (Phase1) (1)The length of ASA >20 mm and bulging >15 mm or a combined total excursion right and left > 15 mm; (2)Secundum ASD with Qp/Qs>1.5 or echocardiographic evidence of right heart enlargement; (3)Failure to cover ASA after trial device-closure of ASD and the unstable device confirmed with push-pull test; 3. Isolated ASA with high risk (Phase2) (1)History of migraine attacks/TIA/cryptogenic stroke without other risks in the last 6 months; (2)Thickening of ASA wall ≥ 5 mm; (3)Spontaneous echo contrast; 4. Left atrial septal pouch (Phase3) (1)History of migraine attacks/TIA/cryptogenic stroke without other risks in the last 6 months; (2)Spontaneous echo contrast in left atrium Acute infection or sepsis; 2. Intra-cardiac thrombus; 3. Carotid, vertebral or basilar artery stenosis > 50% on duplex imaging; 4. Patients unable to grant informed, written consent | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure Congestive Heart Failure Decompensated Heart Failure Subjects must be 18 years of age or older already on standard of care therapy including Angiotensin Converting Enzyme Inhibitors (ACE-I), Angiotensin Receptor Blockers (ARBs), Sacubitril/Valsartan, beta-blocker, oral diuretic (80 mg Lasix/2 mg Bumex/40 mg Torsemide+/-Thiazide diuretic), and meet the following to be enrolled: 1. CHF refractory to oral diuretic (80mg Lasix, 2mg Bumex, or 40mg Torsemide) 2. Volume overload secondary to systolic or diastolic HF, evidenced by at least 2 of the following: 1. Elevated BNP (>100) 2. Paroxysmal nocturnal dyspnea or orthopnea 3. Elevated jugular venous distention (>/ 7 cm) 4. X-ray findings consisted with CHF 5. Presence of ascites or LE edema . - Acute Coronary Syndrome 2. Hypertensive urgency or emergency 3. Rapid atrial fibrillation difficult to control 4. Contraindication to anticoagulation 5. Pregnancy 6. Requires hemodialysis (> CR > 3.0 mg/dl) 7. Symptomatic hypotension 8. Poor venous access 9. Pressor dependent. - | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-65.0, Hypertension; Heart Disease, Hypertensive Age 18-65 years The diagnostic of hypertension were blood pressure systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg in the clinic or receiving antihypertensive drug treatment The normal high-value diagnostic for hypertension were systolic blood pressure 130-139mmhg and or diastolic blood pressure 85-90mmhg in the clinic LVEF > 50% coronary atherosclerotic heart disease or symptoms of angina Cardiomyopathy Valvular heart disease Diabetes Atrial fibrillation Renal function damage Pregnancy Secondary hypertension Chemotherapy for malignant tumors | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Fracture Humerus of Shaft Fracture types 12A-C (OTA/AO classification) 2. Treatment within 14 days from trauma 3. Age 18-64 years for SHAFT-Y and +65 years for SHAFT-E 4. Participants must understand the information given and be able to read and speak Danish, Swedish or Norwegian to complete the study paperwork Inability to give informed consent 2. Undisplaced shaft fracture (less than a cortex-wide displacement in one radiographic plane) 3. Displaced fractures of the proximal and distal humeral (more than a cortex-wide displacement in one radiographic plane) 4. Vascular injury in ipsilateral arm 5. Polytrauma 6. Pathological fracture 7. Open fracture 8. Floating shoulder fractures 9. Floating elbow fractures 10. BMI > 40 11. Health conditions preventing treatment | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, COPD COPD Exacerbation • Moderate to severe COPD ≥2 inpatient or outpatient claims (ER, or urgent care included) in the previous calendar year ≥2 COPD exacerbations in previous year Current established care within the Reno/Sparks area Residing in Washoe County or Carson City County Ability to travel to site Willing to use myAirVo™2 for at least four hours per day but preferably ≥7 hours or overnight and be capable of handling the myAirVo™2 device after instruction Prior PFT data available prior to admission into project Understand and accept oral and written information in English Life expectancy greater than 1 year • End-stage renal disease (ESRD) Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness, COVID-19) Oxygen requirements greater than 6 L/min Bipap or CPAP use in home Receiving hospice care PCP/PI determines the patient is not a good candidate for project Lung CA Active smoker status | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Heart Failure Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit. 2. History of at least one hospitalization for treatment of heart failure within the past 12 months. 3. LVEF greater than 40% as measured by the study-specific transthoracic echocardiography. 4. Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol performed during screening LA diameter greater than 4 cm LA volume index greater than 28 mL Lateral e' less than 10 cm/s Septal e' less than 8 cm/s Lateral E/e' greater than 10 Septal E/e' greater than 15 5. Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak supine cycle ergometer exercise greater than or equa. to 25 mmHg AND (2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg Presence of advanced heart failure defined as one or more of the following ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF Cardiac index less than 2.0 L/min/m2 Patient is on the cardiac transplant waiting list Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months. 2. Presence of moderate or worse valve disease, defined as one or more of the following Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis Moderate or worse tricuspid valve regurgitation Moderate or worse aortic valve disease defined as moderate or worse AS or AI. 3. . Presence of chronic pulmonary disease defined by one or more of the following Requirement for continuous home oxygen use Hospitalization within the past 12 months for treatment of pulmonary disease | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 17.0-81.0, Infection, Coronavirus Respiratory Failure Admission to the Intensive Care Unit with severe pneumonia (clinical signs of pneumonia + one of the following respiratory rate greater than 30/minute; signs of respiratory effort, SatO2 < 90% in room air) COVID-19 confirmed or highly suspicious (positive contact or suggestive image) Diagnosed with cancer (at any stage) Hemodynamic instability (need for vasopressors) Pregnant women; Immunocompromised patients Palliative Care in any other interventionist study Heart failure as a predominant cause of acute respiratory failure Decompensated liver cirrhosis HIV + Dialysis Home / long-term oxygen therapy | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Tricuspid Regurgitation Pre-Inclusion 1. Age > 18 years 2. Symptomatic secondary (at least) severe TR (Carpentier Type IIIB (restrictive) and / or I (tricuspid annulus dilation)) stable for at least 30 days 3. NYHA functional class II to IV without cirrhosis and/or ascites 4. Signs of heart failure in the previous 12-months with or without having been hospitalized 5. Stable optimized medical and/or interventional treatment 6. Ineligible for corrective action on the valve by surgical approach after a specialized multidisciplinary consultation ("heart team") including at least a cardio-thoracic surgeon, an interventional cardiologist, an imaging-cardiologist and an Anesthesiologist). 7. Signature of an informed consent Definitive 8. Central core-laboratory analysis : TR characterized before Implantation by at least one of the following Regurgitation volume > 45 mL / beat Surface of the regurgitant orifice > 40 mm² Vena contracta> 7mm Gap between leaflets ≤ 7 mm Then after the TR severity grading; the Clinical Committee will valid the inclusion. Non 1. Patient treated with Mitraclip or other percutaneous approach on the mitral valve in the past 3-month 2. Any prior tricuspid valve procedure that would interfere with placement of the Triclip device 3. Tricuspid valve leaflet anatomy which may preclude clip implantation, proper clip positioning on the leaflets or sufficient reduction in TR. This may Tricuspid valve anatomy not evaluable by TTE and TEE Active endocarditis Evidence of calcification in the grasping area Evidence of stenosis (mean pressure gradient > 5 mmHg or surface area ≤1cm² Presence of a severe coaptation defect (> 2cm) of the tricuspid leaflets | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Atrial Fibrillation Age >18 years Documented atrial fibrillation by electrocardiogram (ECG) Patients undergoing electrical cardioversion for atrial fibrillation Patients with a baseline transthoracic echocardiography within 1 month prior to the cardioversion Patients who did not convert to normal sinus rhythm after electrical cardioversion Patients who are found to have a LAA thrombus on TEE Patients who do not have a follow up ECG | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-90.0, Hypertension Participants must be age 18 years or older Self-identified as a black or African American male Have uncontrolled hypertension defined as SBP>135 mmHg or DBP>85 mmHg and SBP >130 mmHg or DBP >80 mmHg (in those with diabetes) at the screening Under the age of 18 Does not consent to participate | 1 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Heart Failure Patients being admitted with ADHF over 18 years old Known history of systolic or diastolic dysfunction of greater than 6 weeks NYHA Class II-IV Heart failure as defined in [Table 1]. One symptom must be present at time of screening and one sign must be present in the last 12 months Elevated pro-BNP >/= 360 pg/ml and not explained by any other etiology Willing to consent and comply with scheduled visits and phone calls Table 1. for Diagnosing Heart Failure (at least 1 must be present at time of screening) Paroxysmal nocturnal dyspnea Orthopnea Dyspnea on mild or moderate exertion SIGNS (at least 1 must be present in the last 12 months) Any rales post cough Systolic blood pressure <85 mmHg Signs of significant respiratory distress, according to the discretion of the investigator Biventricular Implantable Cardioverter-Defibrillator(ICD) placement within 15 days, cardiogenic shock or volume depletion Chronic dialysis Acute renal failure defined as creatinine > 2 x baseline Severe systemic illness with life expectancy judged less than three years Chronic pulmonary disease requiring home O2, oral steroid therapy or hospitalization for exacerbation within 12 months, or significant chronic pulmonary disease in the opinion of the investigator Primary hemodynamically significant uncorrected valvular heart disease, obstructive, or regurgitant, or any valvular disease expected to lead to surgery during the trial Atrial fibrillation with resting heart rate >90 bpm Myocardial infarction in past 90 days | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-80.0, Left Atrial Appendage Velocity Left Atrial Structure Left Atrial Function Patients who received atrial fibrillation radiofrequency ablation combined with left atrial appendage closure Patients with incomplete data Device embolism Residual shunt around the device found by transesophageal echocardiography greater than 5 mm Mitral valve stenosis Artificial valve Atrial septal defect Dilated cardiomyopathy Moderate Severe mitral regurgitation | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Hypertension, Pulmonary Informed consent as documented by signature (Appendix Informed Consent Form) PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study inability to follow the procedures of the study patients who take nitrates other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Emergency Department Motivational Interviewing Advance Care Planning Part 1 ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months English-speaking Capacity to consent Acute physical or emotional distress Determined by EM physician not to be appropriate Clearly documented goals for medical care** (Unless the treating clinician recommends that the patient needs the intervention) Delirium (assessed using 3D-CAM) Mild cognitive impairment or dementia (assessed using MiniCog or SBT) Already enrolled in this study Unable/unwilling to schedule the follow-up outcomes assessment on the calendar. Part 2 ≥50 years of age AND ≥1 Serious illness* OR ED clinician would not be surprised if patient died in the next 12 months English-speaking Patient with mild cognitive impairment or mild dementia with caregiver has a capacity to consent | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 19.0-999.0, Eisenmenger Complex Age at least 18 years Patient who was scheduled to change Ambrisentan from Bosentan (prospective arm) or who already changed to Ambrisentan from Bosentan (retrospective arm) Presence of cyanosis with < 95 % arterial oxygen saturation (measured by transcutaneous pulse oximetry) or documented during exercise test (6 minute walk distance test or CPT stress test) Bosentan treatment more than 3months before changing to Ambrisentan and stable medication dosage for 1 month before changing medication Presence of PAH as diagnosed by invasive methods with Rp:Rs > 0.75 measured at rest or diagnosed by echocardiography with TR Vmax > 3.5m/s and bidirectional or right to left shunt One of the following diagnosis: i) non-corrected large congenital shunting defect at atrial, ventricular or arterial level: Partial anomalous venous return, atrial septal defect, ventricular septal defect, atrioventricular cushion defect, persistent ductus arteriosus, or a combination of these. ii) Surgically corrected shunting defect (diagnoses as above) with significant residual defect iii) Other diagnoses with univentricular physiology/haemodynamics. 2 pregnancy or lactation women of child-bearing age who are sexually active without practicing reliable methods of contraception any disease or impairment that, in the opinion of the investigator, excludes a subject from participation substance abuse (alcohol, medicines, drugs) acute decompensated heart failure within 7 days before the invasive procedure significant anemia (Hb < 9.0 g/dl) decompensated symptomatic polycythaemia significant impairment of hepatic function (Child Pugh class C) Significant left ventricular diseases (LV EF < 45%) significant valvular diseases other than tricuspid or pulmonary regurgitation ( mitral or aortic valvular impairment more than moderate degree) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 6.0-10.0, ASD, Anxiety ASD Anxiety Symptoms Anxiety treatment | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Atrial Fibrillation Post-cardiac Surgery Age >/=18 years 2. Undergone heart surgery for coronary artery bypass surgery (on-pump or off-pump CABG) and/or valve repair or replacement (excluding mechanical valves), including re-operations. 3. Hemodynamically stable with/without vasopressor support LVAD insertion or heart transplantation 2. MAZE procedure 3. Transcatheter aortic valve replacement (TAVR) 4. History of or planned mechanical valve replacement 5. Rheumatic heart disease 6. Congenital cardiac defect (excluding bicuspid aortic valve or patent foramen ovale) 7. History of prior atrial fibrillation or flutter 8. History of ablation for atrial fibrillation 9. Contraindication to amiodarone PR >240ms Heart block (2nd or 3rd degree) QTC >480ms Untreated thyroid disorder AST or ALT >2x upper limit of normal Hepatic cirrhosis Interstitial lung disease 10. Received amiodarone within 6 weeks 11. Contraindications to Vernakalant Known hypersensitivity to Vernakalant Prolonged QT | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Acute Respiratory Distress Syndrome Covid19 Myocardial Injury A. 1. Clinical diagnosis of moderate to severe acute respiratory syndrome due to SARS-CoV2 defined as: 1.1. Tachypnea: > 24 breaths per minute 1.2. Hypoxemia: arterial oxygen saturation <94% in room air by pulse oximetry 1.3. Presumptive (or confirmed) diagnosis of SARS-Cov2 infection by at least one of the following 1. Polymerase chain reaction assay (+) for SARS-CoV2 2. Serology (+) for SARS-CoV2 3. SARS-CoV2 antigen diagnostic tests (+) 4. Chest CT with findings suggestive of the diagnosis of COVID-19 in the presence of medical history or clinical signs compatible with the diagnosis of COVID-19 2. Signature of the Informed Consent Form B Chronic renal dysfunction stage 4 (GFR <30mL / min / 1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation 2. Patient on renal replacement therapy by dialysis 3. Pregnant and lactating women 4. Previous use of trimetazidine less than two weeks before hospital admission 5. Any clinical condition at the investigator´s discretion likely to be associated with elevation of baseline hs-troponin >99th percentile | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Chronic Thromboembolic Pulmonary Hypertension Despite 3 months of anticoagulation therapy mean pulmonary arterial pressure > 20 mmHg pulmonary vasculary resistance > 3 wood pulmonary capillary wedge pressure < 15 mmHg perfusion defect in ventilation perfusion scintigraphy pulmonary angiography or computed tomography angiography showing pulmonary artery occlusive lesions Patients undergoing pulmonary thromboendarterectomy concomitant coronary bypass, carotid endarterectomy, aortic valve, ascending aorta, mitral valve, tricuspid valve, pulmonary valve surgery Patients who have undergone surgical or percutaneous procedures due to atherosclerotic disease | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 0.0-999.0, Pulmonary Hypertension Pulmonary Arterial Hypertension Pulmonary Hypertension Due to Left Heart Disease Pulmonary Hypertension, Primary Pulmonary Hypertension Due to Lung Diseases and Hypoxia Pulmonary Hypertension, Primary, 4 Pulmonary Hypertension, Primary, 2 Pulmonary Hypertension, Primary, 3 Chronic Thromboembolic Pulmonary Hypertension The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP) 2. The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization 3. Patient is ≥ 18 years of age or older Participant declines to participate (living patients only) 2. Participant is unable to provide informed consent (living patients only) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Congestive Heart Failure Asthma Chronic Obstructive Pulmonary Disease Cystic Fibrosis Subject age 18 or older 2. Receives all primary and specialty care within the MassGeneral Brigham system 3. A history of one of the following diagnoses: 1. Asthma 2. Cystic Fibrosis 3. Chronic obstructive pulmonary disease 4. Congestive heart failure 4. At least four documented exacerbations of the above disease in the past 12 months as defined by the following corresponding a. Asthma exacerbation: i. a minimum 3-day course of oral steroids ii. for patients on chronic steroids, an increased dose of steroids. b. Cystic fibrosis exacerbation: a minimum 7-day course of systemic antibiotics (not including any chronic suppressive antibiotics). c. Chronic obstructive pulmonary disease exacerbation: all three of (1) increase in frequency and severity or severity of cough, (2) increase in volume and/or change of character of sputum production, and (3) increase in dyspnea, and requiring treatment with short-acting bronchodilators, antibiotics, and oral or intravenous glucocorticoids. d. Congestive heart failure exacerbation: volume overload (as evidenced by weight gain or elevated BNP [>100 pg/mL]/NT-proBNP [>300 pg/mL)) plus dyspnea plus diuretic treatment (new or increase from baseline). 5. Subject able to provide informed consent Subjects with a history of adhesive or tape allergy or skin reaction. 2. Subjects with pacemaker, Automatic Implantable Cardioverter Defibrillator (AICD) and other implantable electronic devices. 3. Subjects with neuromuscular disease, seizures and/or Parkinson's disease. 4. Subjects with expected out of state travel within a 90-day period or travel to a location with no internet access. 5. Subjects enrolled in hospice care or life expectancy less than three months. 6. Subjects living more than 60 miles away from Massachusetts General Hospital. - | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Heart Failure NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit. 2. Medical history within the past 12 months of at least one hospitalization with heart failure as the primary or secondary diagnosis OR treatment with IV diuretics for heart failure.. 3. LVEF (by Echo) > 40% as measured by the study-specific transthoracic echocardiography. 4. Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol: 1. LA diameter > 4cm 2. LA volume index >28 mL 3. Lateral e' <10 cm/s 4. Septal e' <8 cm/s 5. Lateral E/e' >10 6. Septal E/e' >15 5. As measured by the study-specific exercise hemodynamic right heart catheterization protocol performed during screening: Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by: (1) end-expiratory PCWP at peak supine cycle ergometer exercise ≥ 25mmHg AND (2) PCWP greater than RAP by ≥ 5 mmHg, OR (1) ≥ 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND (2) PCWP greater than RAP by ≥ 5 mmHg. Patients must also have PCWP greater than RAP by ≥ 5 mmHg at rest Presence of advanced heart failure defined as one or more of the following ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF Cardiac index less than 2.0 L/min/m2 Patient is on the cardiac transplant waiting list Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months. 2. Presence of moderate or worse valve disease, defined as one or more of the following Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis Moderate or worse tricuspid valve regurgitation Moderate or worse aortic valve disease defined as moderate or worse AS or AI. 3. . Presence of chronic pulmonary disease defined by one or more of the following Requirement for continuous home oxygen use Hospitalization within the past 12 months for treatment of pulmonary disease | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 18.0-999.0, Gout Chronic Kidney Disease Renal Transplantation Adults aged over 18 years old Gout confirmed by identification of urate crystals by joint fluid or tophus analysis or by ultrasound of the affected joint or Gout according to Nijmegen (presence of a score ≥ 8/13) depending on the following items: Man (2 pts) Previous crisis (2 pts) Involvement of first metatarsophalangeal joint (MTP1) (2.5 pts) Maximum pain within 24 hours (0.5pt) Redness (1 pt) HTA or cardiovascular disease (1.5 pts) SUL > 360 μmol/l during the crisis (3.5 pts) Chronic kidney disease stage 4/5 or renal transplantation Flare ≤ 5 days Pain assessed by visual analogical scale ≥ 5 Participating in another trial including the administration of a drug Active infection History of anakinra or prednisone allergy Contra-indication of anakinra or prednisone Neutrophil count < 1000/mm3 (not due to ethnic cause) Difficulty understanding French Illiteracy Pregnant women or breastfeeding mothers (see PHC article L.1121-5) Persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care under Sections L. 3212-1 and L. 3213-1 and persons admitted to a health or social institution for purposes other than research (see CSP Article L.1121-6) Major persons subject to a measure of legal protection or unseeding to express consent (see PHC Article L.1121-8) | 0 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-999.0, Pulmonary Disease, Chronic Obstructive Age 40 years or older Diagnosis of COPD Discharged within the past 3 months after hospitalization for COPD exacerbation, congestive heart failure exacerbation and/or pneumonia Active prescription for supplemental oxygen within 48 hours of discharge that remains active No inpatient or outpatient exacerbations of COPD within the last 30 days Smoked at least 10 pack-years of cigarettes Room air resting saturation >88% on room air Spirometry consistent with COPD (FEV1/FVC < 0.70) and/or evidence of emphysema on CT scan Willingness on the part of the participant to stop oxygen if randomized to the intervention Ability and willingness to participate in virtual video visits with study staff using VA approved software Desaturation during 6MWT <80% for one minute or more Non-COPD lung disease that affects oxygenation or survival (including pulmonary hypertension) Prescription of oxygen for alternative condition (e.g. bleed-in with positive airway pressure therapy for obstructive sleep apnea) Diagnosis expected to result in death in six months or enrollment in hospice Participation in another intervention trial Cognitive issues that would preclude participation (dementia, stroke, etc.) Residence in skilled nursing facility Inability to speak, read, or understand English Any safety concerns | 2 |
79 yo F with multifactorial chronic hypoxemia and dyspnea thought due to diastolic CHF, pulmonary hypertension thought secondary to a chronic ASD and COPD on 5L home oxygen admitted with complaints of worsening shortness of breath. Cardiology consult recommended a right heart cath for evaluation of response to sildenafil but the patient refused. Pulmonary consult recommended an empiric, compassionate sildenafil trial due to severe dyspneic symptomology preventing outpatient living, and the patient tolerated an inpatient trial without hypotension. Patient to f/u with pulmonology to start sildenifil chronically as outpatient as prior authorization is obtained. Past Medical History: - Atrial septal defect repair [**6-17**] complicated by sinus arrest with PPM placement. - Diastolic CHF, estimated dry weight of 94kg - Pulm HTN (RSVP 75 in [**11-24**]) thought secondary to longstanding ASD - COPD on home O2 (5L NC) with baseline saturation high 80's to low 90's on this therapy. - OSA, not CPAP compliant - Mild mitral regurgitation - Microcytic anemia - Hypothyroidism - S/p APPY, s/p CCY ('[**33**]) - Gallstone pancreatitis s/p ERCP, sphincterotomy - Elevated alk phos secondary to amiodarone | eligible ages (years): 40.0-100.0, Copd COPD Exacerbation Male or female patients, aged ≥40 years. 2. Smokers or ex-smokers (≥10 pack-year). 3. Prior hospitalization because of progressively worsening dyspnea (associated or not with increased cough and sputum, and or sputum purulence), with a clinically suspected diagnosis of exacerbations of COPD that prompt the discharging physician to refer the patient to the COPD Center. 4. Signed informed concent form Presenting to the hospital for similar symptoms, which are not defined by the clinicians as suspected exacerbations of COPD, because of alternative diagnoses not related to patients with COPD (e.g., chest wall trauma, neurological disorders, sepsis, cancer and anemia). 2. Already enrolled in other studies perceived to interfere with this protocol. 3. In whom spirometry test is contraindicated (e.g., hemoptysis, detached retina, active tuberculosis). 4. Unable to comply with study procedures and follow-ups in the opinion of the Investigator (e.g., other severe diseases with short life expectancy or who make it impossible for the patients to participate into the study, evidence of alcohol or drug abuse, dementia, severe psychiatric disorder). 5. Acute myocardial infarction and unstable angina pectoris or arrhythmias requiring specific cardiology ICU. 6. Diagnosed stroke, dementia, degenerative neurological disorders or psychiatry disorders requiring specialized care. 7. At the discretion of the recruiting clinician would not be able to be considered for the study | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 16.0-999.0, Lymphoma, Non-Hodgkin HIV Infections Concurrent Medication: Required PCP prophylaxis with Bactrim, dapsone, or aerosolized pentamidine Oral candidiasis prophylaxis with fluconazole, ketoconazole, or clotrimazole oral troches Antiretroviral agent available by therapy IND MAI prophylaxis with rifabutin (in patients with CD4 counts < 100 cells/mm3). Patients must have HIV infection Primary CNS lymphoma with NO systemic involvement. Prior Medication: Allowed Prior corticosteroids Co-existing Condition: Patients with the following symptoms or conditions are excluded Concomitant malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous or basal cell carcinoma of the skin Active uncontrolled infection Renal failure, active nonmalignant duodenal ulcer, uncontrolled diabetes mellitus, or other serious medical conditions that would preclude aggressive cytotoxic chemotherapy administration Active heart disease (congestive heart failure or heart block greater than first degree on EKG). Concurrent Medication: Excluded Any investigational agent other than antiretroviral agents available by therapy IND. Patients with the following prior conditions are excluded No prior malignancy other than Kaposi's sarcoma, curatively treated carcinoma in situ of the cervix, or squamous cell or basal cell carcinoma of the skin No new infectious complications within the past 2 weeks that require a change in antibiotics History of myocardial infarction within the past 3 months. Prior Medication: Excluded Prior chemotherapy other than for Kaposi's sarcoma | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Vasculitis Wegener's Granulomatosis Documentation of WG based on clinical characteristics and histopathological evidence of vasculitis. Patients with a positive C or P-ANCA and glomerulonephritis as evidence by the presence of red blood cell casts and proteinuria or renal biopsy showing necrotizing glomerulonephritis in the absence of positive immunofluorescence for immunoglobulin and complement will also be eligible. Age 10-80 years. Evidence of active disease as defined by a Vasculitis Disease Activity Index of greater than or equal to 3 or if begun on CTX and glucocorticoid at an outside institution, a history of a Vasculitis Disease Activity Index greater than or equal to 3 at the time of therapy initiation Evidence of active systemic infection which, in the judgement of the investigator, is of greater danger to the patient than the underlying vasculitis. In those instances in which infection cannot be ruled out by gram stain and culture of secretions or collections of fluid in involved organs, it may be necessary to obtain a biopsy of the affected tissue for microbiological and histopathological studies. Patients who are pregnant or who are nursing infants will not be eligible. Fertile women must have a negative pregnancy test within one week prior to study entry and must be using an effective means of birth control. Processes associated with an increased risk of MTX toxicity: acute or chronic liver disease, past history of alcohol abuse (greater than 14 oz. of 100 proof liquor or equivalent per week), ongoing alcohol use of any volume that cannot be discontinued upon entry into the study. Serological evidence of infection with human immunodeficiency virus, hepatitis C, or a positive hepatitis B surface antigen. A serological determination will be performed within two weeks of beginning study participation. Inability to comply with study guidelines | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 55.0-71.0, Chronic Lymphocytic Leukemia Graft vs Host Disease Leukemia Myelodysplastic Syndrome Myeloid Leukemia Ages 55-71 years. Chronic myelogenous leukemia (CML): chronic phase. Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission. Acute myelogenous leukemia (AML): AML in first complete or partial remission. Exceptions: AML with good risk karyotypes: AML M3 t(5;17), AML M4Eo (inv. 16), AML t(8;21). All AML in second or subsequent complete remission. Myelodyplastic syndromes: refractory anemia with excess of blasts (less than 10%) or early transformation to acute leukemia or Chronic myelomonocytic leukemia. Chronic lymphocytic leukemia (CLL) with bulky or progressive disease despite prior treatment with chemotherapy which includes purine analogs. Mantle cell lymphoma. Relapsed or progressive non-Hodgkins lymphoma, failing standard treatment approaches and unsuitable for autologous stem cell transplantation. No major organ dysfunction precluding transplantation. DLCO greater than or equal to 40% predicted. Left ventricular ejection fraction: greater than 30% predicted. ECOG performance status of 0-2 DONOR: HLA identical family donor, up to 75 years old. Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke, no history of severe heart disease). Informed consent given Patient or donor pregnant or lactating. Patient age less than 55, greater than 71 years. ECOG performance status of 3 or more. Psychiatric disorder or mental deficiency of the patient or the donor sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible. Major anticipated illness or organ failure incompatible with survival from BMT. DLCO less than 40% predicted. Left ventricular ejection fraction less than 30% predicted. Serum creatinine greater than 2.5 mg/dl. Serum bilirubin greater than 4 mg/dl, transaminases greater than 5 times the upper limit of normal. HIV positive (donor or recipient). Donors who are positive for HBV, HCV, or HTLV will be used at the discretion of the investigator. Other malignant diseases liable to relapse or progress within 5 years. Donor unfit to receive G-CSF and undergo apheresis. (Uncontrolled hypertension, history of heart failure or unstable angina, platelet count less than 90,000/cu mm) | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-70.0, Multiple Myeloma Newly diagnosed, active multiple myeloma of any stage requiring treatment Smoldering myeloma (Durie-Salmon stage I) must have a 25% or greater increase in M component levels and/or Bence-Jones protein excretion or development of symptoms Quantifiable M component of IgG, IgA, IgD, IgE, and/or urinary kappa or lambda light chain (Bence-Jones protein) excretion required Plasmacytosis of at least 30% allowed for non-secretory disease or secretory disease without quantifiable protein IgM peaks excluded Evaluation of siblings as potential allogeneic bone marrow transplant donors required for patients 55 years of age and younger (As of 8/1/97, permanently closed) HLA followed by DR and MLC testing required Renal failure, even on dialysis, eligible provided Cause is attributed to myeloma (Bence-Jones protein or hypercalcemia) Duration does not exceed 2 months | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Multiple Myeloma and Plasma Cell Neoplasm Multiple myeloma confirmed by bone marrow plasmacytosis and with measurable M-component in the serum or urine by immunoelectrophoresis or immunofixation No Stage I myeloma No smoldering multiple myeloma Refractory to or in first relapse following an initial response to VAD (vincristine/doxorubicin/dexamethasone), with relapse defined as any of the following: 50% increase above the lowest remission level of serum or urine M-protein while on therapy 25-50% increase above the lowest remission level of serum or urine M-protein associated with either: Hypercalcemia (greater than 11 mg/dl) Hb decrease of 2 g/dl attributable to increasing marrow plasmacytosis Appearance of new lytic lesions Calcium no greater than 11 mg/dl No myeloma meningitis No plasma cell leukemia Age: 18 to 65 Performance status: ECOG 0-2 Hematopoietic: WBC greater than 500 (after G-CSF) Platelets greater than 25,000 Hepatic: Bilirubin no greater than 2.0 mg/dl Renal: Creatinine no greater than 2.0 mg/dl Cardiovascular: No NYHA class II-IV disease Pulmonary: DLCO at least 50% of predicted FVC at least 75% of predicted FEV1 at least 60% of predicted Other: No uncontrolled infection No active fungal infection No fever No prior malignancy within 5 years except: Basal cell skin cancer In situ carcinoma of the cervix No pregnant or nursing women PRIOR Biologic therapy: Prior biological response modifiers allowed Chemotherapy: No time limit between cytotoxic therapy and protocol treatment Prior cumulative melphalan dose less than 300 mg Endocrine therapy: Corticosteroids for hypercalcemia allowed Radiotherapy: Prior radiotherapy allowed Prior pelvic radiotherapy allowed, but patients with such therapy are unlikely to have adequate PBSC harvested Surgery: Not specified | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 16.0-65.0, Multiple Myeloma and Plasma Cell Neoplasm Primary amyloidosis diagnosed by appropriate amyloid stains or electromicroscopy of abdominal fat, bone marrow, or other target tissues Pathology reviewed by Temple University Amyloidosis secondary to any stage of multiple myeloma allowed provided plasma cell concentration in bone marrow is less than 15% No amyloidosis secondary to rheumatoid arthritis or chronic infection No familial amyloidosis Age to 65 Performance status Karnofsky 80-100% Hematopoietic Not specified Hepatic Liver function tests less than twice normal No active liver disease Renal | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-120.0, Infection Multiple Myeloma Patient must have a diagnosis of multiple myeloma confirmed by the presence of Bone marrow plasmacytosis with >10% abnormal plasma cells or multiple biopsy-proven plasmacytomas, and at least one of the below must be documented: 1. Myeloma protein in the serum 2. Myeloma protein in the urine (free monoclonal light chain) 3. Radiologic evidence of osteolytic lesions (generalized osteoporosis qualifies only if the bone marrow aspirate contains >20% plasma cells) Patients must have no active infection during the prior seven days and be off all antibiotics for the prior seven days Patients cannot have received radiotherapy during the preceding ten days Primary therapy for multiple myeloma must start within three days after entry to this study. For purposes of for this study, myelosuppressive chemotherapy or high-dose dexamethasone based regimens are acceptable as primary therapy. The high-dose dexamethasone regimen must at a minimum, dexamethasone 40 mg per day days 1-4, 9-12, 17-20 for the first cycle and 40 mg per day on days 1-4 of the second cycle Patients who are to receive dexamethasone alone or dexamethasone with thalidomide are among those eligible for this protocol Patients must have a serum creatinine <5.0 mg/dl and not require dialysis at the time of study entry. If patients require dialysis after enrollment, they can continue on the protocol using the adjusted medication guidelines Written informed consent must be obtained prior to entry Patients with smoldering myeloma, history of hypersensitivity to fluoroquinolones or trimethoprim, bone marrow transplant or autologous stem cell rescue planned during the first two months of treatment, patients taking theophylline, or patients previously treated with chemotherapy or high-dose dexamethasone | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Multiple myeloma of any stage confirmed by Bone marrow plasmacytosis with at least 10% plasma cells, sheets of plasma cells, or biopsy proven plasmacytosis Myeloma (M) protein in serum and/or urine Measurable disease by at least one of the following Serum M-component at least 1.0 g/dL by electrophoresis Baseline measurement by nephelometry also, if used to follow response Urine M-protein excretion greater than 200 mg/24 hours by electrophoresis The following are not considered measurable but are followed for response Lytic bone lesions Bone marrow plasmacytosis | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-120.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed recurrent or persistent multiple myeloma at least 6 months following allogeneic bone marrow transplantation (BMT) from an HLA identical sibling Must meet one of following to be considered persistent, recurrent, or progressive disease Residual detectable disease 6-12 months after BMT, as determined by the M protein level or bone marrow involvement, without further evidence of clinical or laboratory improvement on 2 consecutive measurements 4 weeks apart Complete response not achieved 12 or more months after BMT and there is no evidence of progressive improvement At least 25% increase of serum paraprotein (greater than 1.0 g/dL) as measured on two occasions or a 50% increase in urinary light chain excretion (greater than 150 mg/day) as measured on 2 occasions A 10% increase in plasma cells in the bone marrow Disease in complete response but with recurrence of M protein and 10% point increase in myeloma cells in the marrow allowed No lytic lesions alone or new soft tissue plasmacytoma as sole evidence of progression Age and over Performance status ECOG 0-2 Life expectancy | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 2.0-80.0, Myeloproliferative Disorders Acute Myelogenous Leukemia Chronic Myelogenous Leukemia Myelodysplastic Syndrome Acute Lymphoblastic Leukemia Recipients: Group A: Subjects at high risk for transplant related complications and mortality as defined below: Ages 10 to 75 (both inclusive) with a history of one of the following Treatment with dose intensive chemotherapy and/or radiotherapy Previous history of allo/auto transplant History of multiple myeloma or extramedullary plasmacytoma Chronic disease or co-morbid medical condition including subjects with symptoms or signs of significant pulmonary disease, hepatic disease, kidney disease, cardiac disease or disease of other organ systems which would result in increased risk of morbidity or death from a standard myeloablative transplant. Diseases to be included CML chronic phase Acute lymphoblastic leukemia (ALL), all subjects in complete or partial remission AML: AML in first complete or partial remission Exceptions: AML with good risk karyotypes: AML M3 t(15:17), AML M4Eo (inv. 16), AML t(8;21). All AML in second or subsequent complete remission MDS: refractory anemia with excess blasts (RAEB), or chronic myelomonocyte leukemia (CMML) Myeloproliferative diseases associated with either cytopenia or uncontrolled proliferation Recipient any of the following: Pregnant or lactating Group A: age less than 10 or greater than 75 (multiple myeloma age less than 8 or greater than 65); Group B: Age less than 8 or greater than 80 years. ECOG performance status of 3 or more (See NIH Bone and Marrow Consortium Supportive Care Guidelines for Allogeneic Hematopoietic Stem Cell Transplant Recipients - http://intranet.cc.nih.gov/bmt/_pdf/ECOG_Karnofsky_Lansky_Scales.pdf) Psychiatric disorder or mental deficiency severe as to make compliance with the BMT treatment unlikely and making informed consent impossible Major anticipated illness or organ failure incompatible with survival from PBSC transplant Diffusion capacity of carbon monoxide (DLCO) less than 40% predicted. Left ventricular ejection fraction: less than 30%. Serum creatinine greater than 2.5 mg/dl or creatinine clearance less than 50 cc/min by 24 hr urine collection Serum bilirubin greater than 4 mg/dl, transaminases greater than 5x upper limit of normal, Other malignant diseases liable to relapse or progress within 5 years Donor any of the following: Pregnant or lactating Donor unfit to receive G-CSF and undergo apheresis (uncontrolled hypertension, history of congestive heart failure or unstable angina, thrombocytopenia) HIV positive donor. Donors who are positive for hepatitis B (HBV), hepatitis C (HCV) or human T-cell lymphotropic virus (HTLV I/II) will be used at the discretion of the investigator following counseling and approval from the recipient | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-65.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically proven stage I-III multiple myeloma Less than 18 months since diagnosis Smoldering myeloma allowed if there is evidence of progressive disease requiring therapy At least 25% increase in M protein levels or Bence Jones excretion Hemoglobin no greater than 10.5 g/dL Hypercalcemia Frequent infections Rise in serum creatinine above normal on 2 separate occasions Nonquantifiable monoclonal proteins allowed if other for multiple myeloma or smoldering myeloma are met Response/status after induction therapy | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosed active multiple myeloma defined by Lytic disease Anemia Hypercalcemia Secondary renal insufficiency More than 400 mg/24 hours of urinary protein excretion Symptomatic hyperviscosity If previously treated, refractory to no more than 1 regimen Primary amyloidosis without subsequent multiple myeloma allowed Abnormal renal function allowed if due to primary disease Age | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-100.0, Cardiovascular Diseases Heart Diseases Hypertension Kidney Failure, Chronic | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Myelodysplastic Syndrome MDS of refractory anemia (RA), refractory anemia with ring sideroblasts (RARS) & refractory anemia with excess blasts (RAEB) sub-types Off all other treatments (except G-CSF (granulocyte colony stimulating factor), and transfusion support and related medications) for at least four weeks G-CSF can be used before, during and after the protocol treatment for patients with documented neutropenia (less than 500/uL) as long as they meet the for anemia and/or thrombocytopenia as stated above Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less High or intermediate predicted probability of response MDS of FAB sub-group chronic myelomonocytic leukemia (CMML) Transformation to acute leukemia (FAB sub-group RAEB-T, ie., greater than 20% blasts in marrow aspirate) Hypoplastic marrow without one major or two minor Treatment with growth factors (except for G-CSF) or cyclosporine within 4 weeks prior to entry to protocol ECOG performance status of greater than 2 Active uncontrolled infection Current pregnancy, or unwilling to take oral contraceptives if of childbearing potential Patients for whom bone marrow transplant is indicated as standard therapy (age less than fifty-five with a fully-matched sibling donor) Age less than18 years Not able to give informed consent | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-120.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed multiple myeloma M-protein by serum protein electrophoresis or urine protein electrophoresis Quantitative determination of immunoglobulin Bone marrow biopsy and aspirate with a plasma cell count greater than 10% Refractory or chemoresistant disease defined as failure to respond (less than 50% reduction in M protein level) or progression within 2 months after receiving at least 2 chemotherapy regimens including Alkylating based regimen (melphalan) in combination with steroids (prednisone) or other chemotherapy regimens (e.g., vincristine, bleomycin, melphalan, cyclophosphamide, and prednisone or vincristine, carmustine, doxorubicin, and prednisone) Vincristine, doxorubicin, and dexamethasone (VAD) regimen Pulse therapy with high dose steroids alone High dose alkylating agent and autologous stem cell transplantation Allogeneic bone marrow transplantation | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-75.0, Multiple Myeloma Collection of plasma in recipient: Patients with Immunoglobulin G (IgG) or Immunoglobulin A (IgA) multiple myeloma. Patients have siblings. Human leukocyte antigen (HLA) typing of recipient and donor(s) initiated. Viral antibody screening initiated. Recipient: Patients with IgG or IgA multiple myeloma. Patients must have achieved at least a partial remission following initial conventional chemotherapy regimen or after autologous stem cell transplantation. Patients who have undergone tandem autologous stem transplants are eligible if they meet all other criteria. Patients who have achieved at least a partial remission to initial (primary) conventional chemotherapy will be encouraged to proceed to autologous transplantation, but will also be eligible for this protocol. Patients 18-75 years of age. The upper age limit was chosen as it is felt that the toxicities would exceed potential benefit in this older population. Karnofsky performance status greater than or equal to 80%. Life expectancy greater than 6 months. Left ventricular ejection fraction has to be greater than 50% by either multi-gated acquisition scan (MUGA) or 2-D echo. Carbon monoxide diffusing capacity (DLCO) greater than 50% of the expected value when corrected for hemoglobin (Hb)(96). Creatinine less than or equal to 1.5 mg/dl and a creatinine clearance greater than or equal to 50 ml/min. Direct bilirubin less than or equal to 2.0 mg/dl serum glutamic oxaloacetic transaminase (SGOT) less than 4x top normal. M-protein: the concentration in the harvested plasma must be greater than 70% of the total Ig of the corresponding isotype. Patients must be human immunodeficiency virus (HIV)-negative. There is the theoretical possibility that the degree of immune suppression associated with the treatment may result in progression of HIV infection. Patients may be Hepatitis B core antigen positive, but surface antigen negative and without evidence of active infection. Patients must be Hepatitis C negative. Not pregnant or lactating. Patients of childbearing potential must use an effective method of contraception. The effects of the chemotherapy, the subsequent transplant and the medications used after the transplant are highly likely to be harmful to a fetus. The effects upon breast milk are also unknown and may potentially be harmful to the infant. Consenting first degree relative matched at 6/6 or 5/6 HLA antigens, this may a mismatch at the D locus. Ability to give informed consent. Donor: Age 18-75 years. As the potential cerebrovascular and cardiac complications may potentially increase with age, age 75 has been chosen arbitrarily as the upper age limit. However, if it is determined after initial accrual of patients in this upper age range that this procedure is relatively safe, the age range may be extended. No physical contraindications to stem cell donation (i.e. severe atherosclerosis, auto-immune disease, cerebrovascular accident, active malignancy (97). Patients with severe atherosclerosis by history will receive a cardiology consult and be judged eligible on a case by case basis. Donors must be HIV-negative, hepatitis B surface antigen (HBsAg-), and Hepatitis C antibody negative. This is to prevent the possible transmission of these infections to the recipient. Not pregnant or lactating. Donors of childbearing potential must use an effective method of contraception. The effects of cytokine administration on a fetus are unknown and may be potentially harmful. The effects upon breast milk are also unknown and may potentially be harmful to the infant. Normal cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) numbers as defined by Clinical Center standards. Ability to give informed consent | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-74.0, Acute Undifferentiated Leukemia Adult Nasal Type Extranodal NK/T-cell Lymphoma Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Childhood Burkitt Lymphoma Childhood Diffuse Large Cell Lymphoma Childhood Grade III Lymphomatoid Granulomatosis Childhood Immunoblastic Large Cell Lymphoma Childhood Myelodysplastic Syndromes Childhood Nasal Type Extranodal NK/T-cell Lymphoma Chronic Myelomonocytic Leukemia Cutaneous B-cell Non-Hodgkin Lymphoma de Novo Myelodysplastic Syndromes Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue Hepatosplenic T-cell Lymphoma Intraocular Lymphoma Juvenile Myelomonocytic Leukemia Mast Cell Leukemia Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable Myeloid/NK-cell Acute Leukemia Nodal Marginal Zone B-cell Lymphoma Noncutaneous Extranodal Lymphoma Peripheral T-cell Lymphoma Post-transplant Lymphoproliferative Disorder Previously Treated Myelodysplastic Syndromes Primary Systemic Amyloidosis Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Diffuse Small Cleaved Cell Lymphoma Recurrent Adult Grade III Lymphomatoid Granulomatosis Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Childhood Acute Lymphoblastic Leukemia Recurrent Childhood Acute Myeloid Leukemia Recurrent Childhood Anaplastic Large Cell Lymphoma Recurrent Childhood Grade III Lymphomatoid Granulomatosis Recurrent Childhood Large Cell Lymphoma Recurrent Childhood Lymphoblastic Lymphoma Recurrent Childhood Small Noncleaved Cell Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma Recurrent Marginal Zone Lymphoma Recurrent Mycosis Fungoides/Sezary Syndrome Recurrent Renal Cell Cancer Recurrent Small Lymphocytic Lymphoma Recurrent/Refractory Childhood Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia Refractory Hairy Cell Leukemia Refractory Multiple Myeloma Small Intestine Lymphoma Splenic Marginal Zone Lymphoma Stage II Multiple Myeloma Stage III Multiple Myeloma T-cell Large Granular Lymphocyte Leukemia Testicular Lymphoma Waldenström Macroglobulinemia Patients aged > 49 years and < 75 years with non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) and multiple myeloma who are not eligible for a curative autologous transplantation or who have failed prior autologous transplantation; patients with NHL and CLL must have failed prior therapy with an alkylating agent and/or fludarabine, or be at high risk of relapse; patients with multiple myeloma must have stage II or III disease and received prior chemotherapy Patients < 50 years of age with NHL, CLL or multiple myeloma at high risk of regimen related toxicity through prior autologous transplant or through pre-existing medical conditions Patients < 75 years of age with other malignant diseases treatable by allogeneic bone marrow transplant (BMT) whom through pre-existing chronic disease affecting kidneys, liver, lungs, and heart are considered to be at high risk for regimen related toxicity using standard high dose regimens; the following diseases are the likely candidates Myelodysplastic syndromes Myeloproliferative syndromes Acute Leukemia with < 10% blasts Amyloidosis Hodgkin's disease Renal cell carcinoma Patients with other malignancies declining standard allografts may be approved for transplant following presentation and approval by the Fred Hutchinson Cancer Research Center (FHCRC) chimerism group Eligible for a high-priority curative autologous transplant Patients with rapidly progressive aggressive NHL unless in minimal disease state Active central nervous system (CNS) involvement with disease Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment Females who are pregnant Patients who are human immunodeficiency virus (HIV) positive Cardiac ejection fraction < 40% Severe defects in pulmonary function testing (defects are currently categorized as mild, moderate and severe) as defined by the pulmonary consultant, or receiving supplementary continuous oxygen Total bilirubin > 2 x the upper limit of normal Serum glutamate pyruvate transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT) 4 x the upper limit of normal | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 16.0-120.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically proven multiple myeloma Initial diagnosis must have been confirmed by one of the following prior to initial treatment for multiple myeloma: Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis Bone marrow containing less than 10% plasma cells but with at least 1 bony lesion and the M-protein outlined below Measurable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR If only light chain disease (urine M-protein only) present, then the urinary excretion of light chain (Bence Jones) protein must have been at least 1.0 g/24 hours at time of initial diagnosis Must have undergone autologous stem cell transplantation within 1 year of beginning initial chemotherapy for multiple myeloma Must be randomized 60-100 days after autologous stem cell infusion No evidence of progressive disease Age: 16 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: See Disease Characteristics Granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 1.5 times ULN Renal: Creatinine no greater than 3 times ULN Cardiovascular: No uncontrolled hypertension Other: Not pregnant or nursing Negative pregnancy test Fertile female patients must use 2 effective methods of contraception (1 barrier and 1 hormonal) during and for 1 month after study Fertile male patients must use effective barrier contraception during and for 1 month after study No other medical condition that would preclude long term use of prednisone or thalidomide No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix No diabetes with end stage organ damage No history of gastric ulceration or bleeding No avascular necrosis of the hips No peripheral neuropathy causing symptomatic dysfunction Sensory symptoms induced by vincristine allowed No demonstrated hypersensitivity to thalidomide or its components No other major medical illness that would increase risk or preclude study No employment that prohibits the use of sedatives (due to known effect of thalidomide) PRIOR Biologic: See Disease Characteristics No prior thalidomide Chemotherapy: See Disease Characteristics Endocrine: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No other concurrent anticancer treatment No other concurrent investigational therapy | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed multiple myeloma OR Primary systemic amyloidosis resulting in significant organ dysfunction and decreased quality of life Complete or partial response after standard chemotherapy Primary refractory or relapsed multiple myeloma after first-line treatment with standard chemotherapy Ineligible for higher priority national or institutional clinical studies Age and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 2 times normal Renal | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Adult Langerhans Cell Histiocytosis Childhood Langerhans Cell Histiocytosis Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Diagnosis of one of the following Chronic myelogenous leukemia Philadelphia chromosome-positive OR Molecular evidence of bcr/abl gene rearrangement Acute myeloid leukemia, acute lymphocytic leukemia, lymphoma, histiocytoses, myelodysplasia, juvenile chronic myelomonocytic leukemia, aplastic anemia, paroxysmal nocturnal hemoglobinuria, or Fanconi's anemia Confirmed by cytochemistry, immunophenotyping, and/or chromosomal abnormalities Multiple myeloma Hereditary immunodeficiency disorders Confirmed by immunologic determination Sickle cell anemia or beta-thalassemia | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-70.0, Multiple Myeloma and Plasma Cell Neoplasm Newly diagnosed multiple myeloma (diagnosis within 12 months of study) and scheduled to undergo autologous peripheral blood stem cell transplantation Prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma (SMM) allowed if the for diagnosis of multiple myeloma was met within 12 months of study Serum or urinary M-protein confirmation of diagnosis (IgA, IgD, IgG, IgE, or light chain proteins) At least 10% plasma cells in bone marrow Must have received induction therapy without disease progression or relapse after initial response Prior induction therapy must have been completed no more than 6 months before stem cell collection and no more than 9 months before transplantation Must have undergone stem cell mobilization with cyclophosphamide IV and filgrastim (G-CSF) The following diagnoses are excluded: Non-secretory multiple myeloma IgM myeloma Solitary bone or extramedullary plasmacytoma Symptomatic MGUS or SMM Symptomatic indolent multiple myeloma Age: 18 to 70 Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 2 mg/dL SGPT no greater than 2 times upper limit of normal No clinical evidence of amyloidosis involving the liver Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 30 mL/min No clinical evidence of amyloidosis involving the kidney Cardiovascular: LVEF at least 50% No evidence of amyloidosis on echocardiogram No uncontrolled arrhythmia No symptomatic cardiac disease Pulmonary: FEV1 at least 60% OR FVC at least 60% OR DLCO at least 60% No symptomatic pulmonary disease No clinical evidence of amyloidosis involving the lungs Other: HIV negative No cord compression No other concurrent illness that would preclude survival No clinical evidence of amyloidosis involving the autonomic nervous system or gastrointestinal tract No known allergy to vitamin C Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR Biologic therapy: See Disease Characteristics No prior thalidomide for myeloma No prior peripheral blood stem cell or bone marrow transplantation No concurrent thalidomide No concurrent interferon Chemotherapy: See Disease Characteristics No prior clarithromycin for myeloma No more than 2 courses of prior induction therapy containing an alkylating agent Endocrine therapy: No concurrent dexamethasone Radiotherapy: No prior radiotherapy to more than 20% of bone marrow No greater than 30 Gy to the spinal cord Surgery: Not specified Other: At least 28 days since prior bisphosphonates No prior new or experimental agents for myeloma No concurrent experimental therapies No concurrent bisphosphonates | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-70.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of multiple myeloma meeting 1 of the following Bone marrow plasmacytosis with at least 10% plasma cells Sheets of plasma cells Biopsy-proven plasmacytoma Meets at least 1 of the following Presence of myeloma (M)-protein in the serum Presence of M-protein in the urine Radiographic evidence of osteolytic lesions Generalized osteoporosis allowed if at least 20% plasma cells in bone marrow No non-secretory myeloma | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Gastrointestinal Carcinoid Tumor Islet Cell Tumor Lung Cancer Neoplastic Syndrome Histologically confirmed low-grade neuroendocrine tumors Carcinoid tumors Islet cell tumors Metastatic disease Progression of disease within past 4 weeks by radiological evidence At least 1 bidimensionally measurable lesion by CT scan or MRI Bone metastasis not considered measurable if only site of disease No active brain metastases Age Not specified Performance status Karnofsky 70-100% Life expectancy | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed multiple myeloma Stage II or III No systemic amyloid light-chain amyloidosis Age to 65 Performance status WHO 0-3 Life expectancy Not specified Hematopoietic Not specified Hepatic No significant hepatic dysfunction* Bilirubin less than 1.75 mg/dL* AST/ALT less than 2.5 times normal* NOTE: *Unless related to myeloma Renal | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Multiple Myeloma Previously untreated patients with symptomatic or progressive asymptomatic multiple myeloma. for progression among patients with asymptomatic disease new lytic bone lesions, rise of serum myeloma protein to >5.0 gm/dl or fall of Hgb to <10.5 gm/dl Overt infection or unexplained fever should be resolved before treatment or treated concurrently with antibiotics Patients must provide written informed consent indicating that they are aware of the investigational nature of this study Patients with idiopathic monoclonal gammopathy or stable asymptomatic myeloma are ineligible Patients whose only prior therapy has been with local radiotherapy or alpha interferon are eligible Patients treated with steroids in order to stabilize disease within 60 days prior to enrollment are eligible Patients exposed to longer periods of high-dose glucocorticoid, or with any exposure to thalidomide or alkylating agent are ineligible | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Multiple Myeloma Previously untreated patients with multiple myeloma and without serious or imminent complications (e.g. impending pathologic fracture, hypercalcemia, renal insufficiency). All asymptomatic patients with low or intermediate tumor mass will qualify Patients with high tumor mass, symptomatic or impending fractures, hypercalcemia (corrected calcium >11.5 mg%), anemia (Hgb <8.5 gm/dl), renal failure (creatinine >2.0 mg/dl), high serum lactate dehydrogenase (>300 U/L) or plasma cell leukemia (>1000/ul) are ineligible Overt infections or unexplained fever should be resolved before treatment. Adequate liver function (including SGPT, bilirubin and LDH) is required Patients must have Zubrod performance of 1 or less Patients must provide written informed consent indicating that they are aware of the investigational nature of this study Life expectancy should exceed 1 year Patients with idiopathic monoclonal gammopathy and non-secretory multiple myeloma are ineligible. Patients whose only prior therapy has been with local radiotherapy, alpha-IFN, or ATRA are eligible. Patients exposed to prior high-dose glucocorticoid or alkylating agent are not eligible | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Multiple Myeloma Newly diagnosed multiple myeloma requiring treatment Smoldering myeloma with evidence of progressive disease requiring chemotherapy More than 25% increase in M component levels and/or Bence-Jones excretion or symptom development Non-secretory patients with at least 30% bone marrow plasmacytosis No IgM peaks unless there is evidence of more than 30% bone marrow plasmacytosis or more than 3 lytic lesions Age to 65 Performance status Zubrod 0-2 OR Zubrod 3-4 based solely on bone pain Life expectancy Not specified Hematopoietic No untreated, unresolved symptomatic hyperviscosity Hepatic | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-70.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of multiple myeloma (MM) Patients with a prior diagnosis of monoclonal gammopathy of undetermined significance (MGUS) or smoldering myeloma are eligible if they progressed and met the for diagnosis of MM No non-secretory MM No symptomatic MGUS, smoldering MM, or indolent MM No solitary bone or extramedullary plasmacytoma No immunoglobulin M myeloma Prior induction therapy for myeloma required Responding, stable, or progressive disease after induction therapy, or relapsed disease Candidate for autologous hematopoietic stem cell transplantation Prior stem cell mobilization with chemotherapy and growth factors according to institutional procedures | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Cancer Histologically confirmed malignancy not amenable to curative surgery, radiotherapy, or chemotherapy Tumor types may any of the following Any solid tumor including, but not limited to, head and neck, breast, lung, gastrointestinal, genitourinary, melanoma, and sarcoma Primary CNS neoplasms if the following are true Received primary radiotherapy No concurrent corticosteroids or has been on a stable corticosteroid dose for at least 30 days No concurrent enzyme-inducible anti-epileptic medications (i.e., carbamazepine or phenytoin) Multiple myeloma Non-Hodgkin's lymphoma No refractory or relapsed acute or chronic leukemia | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 16.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Histologically confirmed multiple myeloma as evidenced by one of the following Biopsy of an osteolytic lesion or soft tissue tumor composed of plasma cells Bone marrow aspirate and/or biopsy demonstrating at least 10% plasmacytosis Bone marrow less than 10% plasma cells with at least 1 bony lesion and meets the M-protein as below Detectable serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR Urinary excretion of light chain (Bence Jones) protein at least 1.0 gm/24 hrs if only light chain disease (urine M-protein) was present at initial diagnosis Previously treated with autologous stem cell transplantation after high-dose melphalan (200 mg/m^2) within the past 60-100 days Received transplantation within 1 year of the beginning of initial chemotherapy for multiple myeloma No evidence of disease progression Age and over Performance status | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Newly diagnosed stage I, II, or III multiple myeloma (MM) No refractory or relapsed MM Age and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 1.5 mg/dL AST less than 2.5 times upper limit of normal Renal Not specified Other Not pregnant or nursing | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative Childhood Myelodysplastic Syndromes Chronic Myelogenous Leukemia, BCR-ABL1 Positive Disseminated Neuroblastoma Malignant Neoplasm Ovarian Choriocarcinoma Ovarian Embryonal Carcinoma Ovarian Immature Teratoma Ovarian Mature Teratoma Ovarian Mixed Germ Cell Tumor Ovarian Monodermal and Highly Specialized Teratoma Ovarian Polyembryoma Ovarian Yolk Sac Tumor Previously Treated Myelodysplastic Syndromes Recurrent Adult Acute Lymphoblastic Leukemia Recurrent Adult Acute Myeloid Leukemia Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Adult Hodgkin Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult Lymphoblastic Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Mantle Cell Lymphoma Recurrent Neuroblastoma Recurrent Ovarian Epithelial Cancer Recurrent Ovarian Germ Cell Tumor Refractory Chronic Lymphocytic Leukemia Refractory Multiple Myeloma Relapsing Chronic Myelogenous Leukemia Stage I Multiple Myeloma Stage II Multiple Myeloma Stage II Ovarian Epithelial Cancer Stage III Malignant Testicular Germ Cell Tumor Stage III Multiple Myeloma Stage III Ovarian Epithelial Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage IV Ovarian Epithelial Cancer Testicular Choriocarcinoma Testicular Choriocarcinoma and Embryonal Carcinoma Testicular Choriocarcinoma and Seminoma Testicular Choriocarcinoma and Teratoma Testicular Choriocarcinoma and Yolk Sac Tumor Testicular Embryonal Carcinoma Testicular Embryonal Carcinoma and Seminoma Testicular Embryonal Carcinoma and Teratoma Testicular Embryonal Carcinoma and Teratoma With Seminoma Testicular Embryonal Carcinoma and Yolk Sac Tumor Testicular Embryonal Carcinoma and Yolk Sac Tumor With Seminoma Testicular Teratoma Testicular Yolk Sac Tumor Testicular Yolk Sac Tumor and Teratoma Testicular Yolk Sac Tumor and Teratoma With Seminoma Diagnosis of persistent or progressive hematologic malignancy or solid tumor after allogeneic hematopoietic stem cell transplantation (AHSCT) Patients are eligible for study entry at any time between post-transplantation day 90 and 3 years after withdrawal of immunosuppressive therapy Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that meets any of the following hematologic relapse by standard hematologic persistence evidenced by bone marrow blasts > 10% after day 30 post-AHSCT Cytogenetic progression as evidenced by an increase in the percentage of Philadelphia chromosome (Ph)1-positive metaphases (or Ph1-positive cells by fluorescent in situ hybridization) from complete cytogenetic response (0% Ph1-positive cells) to partial response (1-34% Ph1-positive cells); PR to minor response (35-94% Ph1-positive cells); or MR to no response (95-100% Ph1-positive cells) Resistance to imatinib mesylate, defined as disease progression (hematologic, cytogenetic, or molecular) during OR failure to respond to (i.e., lack of complete hematologic response after 3 months, lack of partial cytogenetic response after 6 months, or lack of complete cytogenetic response after 12 months) prior imatinib mesylate therapy Myelodysplastic syndromes that meet any of the following Hematologic relapse by standard cytogenetic relapse evidenced by recurrence of clonal abnormality in patients who achieved CCR after AHSCT, hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT OR; Hematologic persistence evidenced by cytopenias not attributable to other post-transplant causes accompanied by characteristic morphological changes more than 90 days after AHSCT, or cytogenetic persistence evidenced by persistence of clonal abnormality more than 90 days after AHSCT Chronic lymphocytic leukemia that meets any of the following greater than 25% increase in absolute lymphocytosis of > 5,000/mm3, greater than 25% increase in measurable lymphadenopathy, persistence of absolute lymphocytosis of > 5,000/mm3 at day 90 or later after AHSCT, persistence of lymphadenopathy of ≥ 3 cm in diameter at day 90 or later after AHSCT Aggressive non-Hodgkin's lymphoma (e.g., diffuse large cell lymphoma, lymphoblastic lymphoma, mantle cell lymphoma, or peripheral T cell lymphoma), Hodgkin's lymphoma, OR solid tumor that meets any of the following greater than 50% increase in measurable or evaluable disease, persistence of measurable lesions > 3.0 cm in diameter at day 90 or later after AHSCT OR Persistence of malignancy by biopsy or positron emission tomography scan unless there is clear evidence of progression | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Kidney Failure, Chronic Multiple Myeloma End-stage renal disease (ESRD) due to or in association with stage II or greater multiple myeloma Participants in whom the development of ESRD is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, high-dose radiation therapy with autologous stem cell transplantation) On dialysis or have a creatinine clearance greater than 20 ml/min HLA-matched or one of six HLA antigen-mismatched related donor Compromised pulmonary, cardiac, or liver function Active infection | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-120.0, Multiple Myeloma Plasma Cell Myeloma At least 1 of the following diagnoses Multiple myeloma Stage II or III disease At least 1 of the following must be present Serum M-protein of IgG, IgA, IgD, IgE greater than 1.0 g/dL Urinary M-protein (Bence-Jones) at least 200 mg/24 hours No IgM peaks except in patients who have physiologic to support a diagnosis of multiple myeloma (e.g., bony lesions, myeloma kidney-cast nephropathy, absence of adenopathy [unless pathology-proven to be plasma cell infiltration]) No monoclonal gammopathy of undetermined significance No indolent or smoldering myeloma No disease progression on prior thalidomide or dexamethasone | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Multiple Myeloma Plasma Cell Neoplasm Histologically confirmed AL amyloidosis Persistent or recurrent disease after 1 course of prior high-dose chemotherapy Previously treated with autologous stem cell transplantation Significant initial improvement in organ function after prior high-dose melphalan, defined by at least 1 of the following Complete hematologic remission (e.g., absence of monoclonal spike by immunofixation in serum and urine AND less then 5% plasma cells in bone marrow with no clonal predominance) OR partial hematologic response (e.g., any decrease in serum or urine monoclonal protein OR decrease in bone marrow plasmacytosis) Greater than 50% reduction in proteinuria with preservation of creatinine clearance Greater than 50% reduction in alkaline phosphatase OR at least 2 cm decrease in liver size by physical exam Subjective neurologic improvement, as confirmed by neurologist Cardiac stabilization of disease confirmed by echocardiography defined as less than 2 mm increase in mean wall thickness and/or less than 20 g increase in left ventricular mass Improvement in performance status* NOTE: *This alone does not constitute significant improvement in organ function No myelodysplastic syndromes No abnormal bone marrow cytogenetics Other Not pregnant or nursing Fertile patients must use effective contraception Acceptable toxicity from first transplantation, confirmed by the transplant team HIV negative No other concurrent malignancy except treated skin cancer | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Multiple Myeloma Histologically confirmed AL amyloidosis, meeting 1 of the following Plasma cell dyscrasia, evidenced by 1 of the following Monoclonal protein in the serum or urine by immunofixation electrophoresis Plasmacytosis of the bone marrow with monoclonal staining for kappa or lambda light chain isotype Macroglossia with at least 1 other site having biopsy proven amyloidosis and absence of a mutant transthyretin is ruled out Age to 65 Performance status SWOG 0-2 Life expectancy At least 1 year Hematopoietic Not specified Hepatic Not specified Renal No senile, secondary, localized, dialysis-related, or familial amyloidosis No overt multiple myeloma (e.g., greater than 30% bone marrow plasmacytosis, extensive [more than 2] lytic lesions, hypercalcemia) Cardiovascular No myocardial infarction within the past 6 months No congestive heart failure No arrhythmia refractory to therapy No evidence of symptomatic transient ischemic attacks or strokes No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Male and female adult patients 18 years or older with a diagnosis of relapsed multiple myeloma requiring therapy will be eligible for this study. Key Karnofsky Performance Status (KPS) equal to or greater then 70%, normal liver function tests (aspartate transaminase [AST] or alanine transaminase [ALT] equal to or less then 2 x upper limit of normal [ULN], total bilirubin equal to or less then 1.5 x ULN), hemoglobin equal to or greater then 10 g/dL, platelets equal to greater then 50 x 10 to ninth power/L, and absolute neutrophil count (ANC) equal to or greater then 1000/uL; calculated creatinine clearance equal to or greater then 50 mL/min, and normal serum calcium. Key Patients with significant cardiac disease, equal to or greater then Grade 2 neuropathy, active hepatitis, HIV infection, secondary malignancy, POEMS syndrome, plasma cell leukemia, or who are transfusion-dependent or received extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy within 4 weeks of enrollment will be excluded. Patients taking concurrent medications at entry that may act as inducers or inhibitors of CYP 3A4 are excluded. Patients receiving thalidomide must discontinue that drug at least 2 weeks prior to enrollment. Patients receiving concurrent corticosteroids must have tapered their dose of corticosteroid to to equal to or less then 10 mg/day of prednisone or prednisone equivalent at least 2 weeks prior to enrollment | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients must have a diagnosis of Smoldering or Indolent myeloma All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines Prior bisphosphonate therapy within 30 days prior to study entry Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl Prior plicamycin or calcitonin within 2 weeks of study entry Severe cardiac disease, unstable thyroid disease, or epilepsy Prior radiation therapy to > 20% of the skeleton | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients must have a diagnosis of Multiple myeloma with poor hematopoietic reserve (platelet count <100,000 OR inability to collect adequate PBSC to support autologous transplant (4X106 CD34+cells/kg OR WBC <2,000) Patients must not be eligible for UARK 98-035 Patients must be at least 6 weeks beyond previous chemotherapy All patients must be informed of the investigational nature of this study and must sign a written informed consent in accordance with UAMS Human Research Advisory Committee and federal guidelines Prior bisphosphonate therapy within 30 days prior to study entry Serum creatinine > 5 mg/dl, ascites, or serum direct bilirubin > 2.5 mg/dl Prior plicamycin or calcitonin within 2 weeks of study entry Severe cardiac disease, unstable thyroid disease, or epilepsy | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-70.0, Multiple Myeloma A subject must meet all of the following to be eligible for the study. These will be evaluated within four weeks prior to enrollment Subject must have primary refractory multiple myeloma defined as having failed to achieve an objective response (CR or PR using EBMT/IBMTR/ABMTR criteria) to any therapy since the initiation of induction therapy. At least one previous therapy must be a qualifying therapy that includes high dose pulsed steroids There must be < 18 months from the beginning of induction therapy to time of enrollment on study Subject must meet institutional guidelines for autologous PBSCT Subject must have a minimum of 2 x 106 unmanipulated CD34+ cells/kg cryopreserved and available for transplant Age 18 and 70 years Adequate pulmonary function defined by FEV1, FVC and DLCO > or = 50% of predicted Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) of > or = 45%, with no evidence of cardiac amyloidosis Adequate liver function, defined as serum total bilirubin < or = 2x institutional laboratory upper limit of normal and ALT/SGPT < or = 3x institutional laboratory upper limit of normal Adequate renal function, defined as 24 hour measured creatinine clearance of > or = 50 mL/min/1.73 m2 BSA and serum creatinine < or = 1.8 mg/dL A subject meeting any of the following is not eligible for participation in the study Non-secretory multiple myeloma Asymptomatic MGUS, smoldering multiple myeloma, or indolent multiple myeloma Solitary bone or extramedullary plasmacytoma Waldenstrom's macroglobulinemia (IgM myeloma) Evidence of disease progression (such as new bone lesions) in the setting of a greater than 50% reduction in M-protein Absence of previous therapy with pulsed corticosteroids for multiple myeloma Previous high-dose therapy with stem cell or bone marrow transplant, including autologous, allogeneic, and reduced-intensity or non-myeloablative allogeneic transplants Life expectancy severely limited by concomitant illness (less than 6 months) Evidence of symptomatic spinal cord compression or pathological fracture within 3 months | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma All patients must have a confirmed diagnosis of previously treated, active multiple myeloma Myeloma protein should be evident from which to evaluate response Must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug Patients must have a total white blood cell count of 2,000 K/microliters. Patients may be anemic or thrombocytopenic provided this is felt to be due to extensive marrow involvement with myeloma Patients must have adequate liver function as demonstrated by a direct bilirubin of < or = 2.0 mg/dL Patients must not have an active infection requiring parenteral antibiotics No other concurrent therapy for myeloma is permitted while on Thalidomide | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with relapse or progression following at least one autologous transplant. High risk is defined as any one of the following at the time of relapse:a) Plasma cell labeling index (PCLI) > 1%, b) Bone marrow plasmacytosis > or = 30%, c)Bartl grade >or = 2 on bone marrow biopsy, or d)Cytogenetic abnormalities of chromosome 13, 11q, or any translocation at the time of relapse Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination Patients must have a SWOG performance status of 0-2. Patients with a poor performance status (3-4) based solely on bone pain, will be eligible Patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl Before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. Written report of a negative pregnancy test must be obtained before a prescription for thalidomide is issued. Pregnancy testing is not required for 1) women wh have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy Patients must have adequate bone marrow function, as defined by platelet count of 150,000/microliter, unless explained by extensive marrow plasmacytosis Patients must be off chemotherapy (excluding steroids) and local radiotherapy for > 3 weeks prior to entering the study There must be no evidence of active infection requiring IV antibiotics No other concurrent therapy for myeloma is permitted while on protocol | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma All patients must have a confirmed diagnosis of previously treated, active multiple myeloma, with hypoproliferative/low risk relapse following at least one autologous transplant Patients must be 18 years of age or older. Women of childbearing age and fertile men must use a medically acceptable means of birth control while on study and for 6 months thereafter Patients must sign an informed consent to participate in this study, and be fully aware of the known teratogenic potential of this drug combination Patients must have a SWOG performance status of 0-2 Patients must have adequate renal function, as defined by serum creatinine < or = 3.0 mg/dl Patients must be off chemotherapy (including steroids) and local radiotherapy for > or equal 3 weeks prior to entering the study No other concurrent therapy for myeloma is permitted while on protocol There must be no evidence of active infection requiring IV antibiotics | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma and Plasma Cell Neoplasm Diagnosis of primary systemic (AL) amyloidosis within the past 12 months High or low-risk disease, determined by the extent of systemic organ involvement with disease and patient age Age and over Performance status SWOG 0-3 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No New York Heart Association class III or IV congestive heart failure | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with multiple myeloma who have received at least 1 prior therapy and who have either responded and later had progressive disease or have progressed during their first therapy (primary refractory) are eligible for the study Patients who may have received prior doxorubicin but not more than a cumulative dose of 240 milligram per meter square (mg/m^2) doxorubicin, DOXIL, or the equivalent amount of another anthracycline (i.e., 1 mg doxorubicin = 1 mg DOXIL/CAELYX = 1.8 mg epirubicin = 0.3 mg mitoxantrone = 0.25 mg idarubicin) Must have normal cardiac function, as evidenced by a left LVEF within institutional normal limits History of treatment with or progressive disease while receiving an anthracycline-containing regimen No change in disease status during initial therapy No treatment for malignancy within past 5 yrs (other than multiple myeloma) or progressive disease while receiving anthracycline-containing regimen Non-secretory disease Myocardial infarct within past 6 months No major surgery in past 30 days | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Acute Myelogenous Leukemia Confirmed diagnosis of acute myelogenous leukemia (AML) refractory to prior therapy and/or unlikely to benefit from known therapies Subjects must have adequate organ and immune function as indicated by the following laboratory values: *Creatinine clearance ≥5 L/hr (83mL/min), *Total Bilirubin ≤2.0 mg/dL (≤34.2 µmol/L), *AST(SGOT) and ALT(SGPT) ≤3 x ULN Clinical evidence of active central nervous system (CNS) leukemic involvement Active and uncontrolled infection Uncontrolled medical problems unrelated to the malignancy that impair their ability to give informed consent or unacceptably reduce the safety of the proposed treatment Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up Known or suspected intolerance or hypersensitivity to the investigational new drug or closely related compounds like lamivudine, and/or a recent history of alcohol or other substance abuse Also not eligible are subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrollment Females with a positive pregnancy test at screening or subjects that have previously been enrolled into this study and subsequently withdrew | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Waldenstrom Macroglobulinemia Patients must have a pathological diagnosis of Waldenstrom's Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the following must be true: *Presence of cytopenias, defined as Hemoglobin < 11 gm%, or WBC < 2000/µl, or platelets < 100,000 µl; *Presence of extensive (>3 cm) or symptomatic lymphadenopathy or hepatosplenomegaly; *Presence of B symptoms (night sweats, fever, weight loss of >10% of the baseline); *Presence of severe neuropathy, not otherwise explained; *Progressive disease (increase in "M" by > 50% while observed, and decrease in hemoglobin by >2 gm%,and/or decrease in platelets by >50,000/µl, and/or increase in lymphadenopathy); *Serum albumin <2.5 gm%; *Persistently elevated β-2M >3.0 in the absence of renal impairment or active infection Hyperviscosity will be treated (in addition to plasmapheresis) only in the presence of any of the above All necessary baseline studies for determining must be obtained within 35 days prior to registration Patients must have a performance status of 0-2 based on SWOG criteria. Patients with a poor performance status (3-4), based solely on bone pain, will be eligible Patients must not have significant co-morbid medical conditions or uncontrolled life threatening infection Patients with recent (< 6 months) myocardial infarction, unstable angina, difficult to control congestive heart failure, uncontrolled hypertension, or difficult to control cardiac arrythmias are ineligible. Ejection fraction by ECHO must be > 50% and must be performed within 60 days prior to registration, unless the patient has received chemotherapy within that period of time (dexamethasone and thalidomide excluded), in which case the LVEF must be repeated Patients must have a creatinine < 3 mg/dl and a creatinine clearance > 30 ml/minute. Patients with a creatinine clearance of 30-50 ml will only receive a 50% cisplatin dose Patients must have adequate hepatic function defined as serum transaminases < 2 x ULN and direct bilirubin < 2.0 mg/dl Patients must be able to receive full doses of DT PACE, in the opinion of the treating investigator, with the exception of: *Patients that have received prior adriamycin > 450 mg/m2 and LVEF < 55%. Adriamycin will be omitted in these patients; *Patients with a creatinine clearance 30 ml/minute, who will receive 50% of the cisplatin dose No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least three years. Prior malignancy is acceptable provided there has been no evidence of disease within the three-year interval Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Subjects must satisfy the following to be enrolled in the study Male or female Not a candidate for HDT/SCT due to: age subject is 65 years or older or in subjects less than 65 years of age presence of important comorbid condition(s) likely to have a negative impact on tolerability of HDT/SCT Symptomatic multiple myeloma or asymptomatic multiple myeloma with related organ or tissue damage. Asymptomatic multiple myeloma-related organ or tissue damage can presence of asymptomatic lytic bone lesion or plasmacytoma, or presence of anemia, renal function impairment, or hypercalcemia, as long as the for pre-treatment clinical laboratory values indicated below are met Presence of measurable disease, defined as For secretory multiple myeloma, measurable disease is defined as any quantifiable serum monoclonal protein value For oligosecretory or nonsecretory multiple myeloma, measurable disease is defined by the presence of measurable soft tissue or organ (not bone) plasmacytomas as determined by clinical examination or applicable radiographs Karnofsky performance status score of equal or greater then 60% Potential subjects who meet any of the following will be excluded from participating in the study Diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS, hypercalcemia, and renal insufficiency related to the monoclonal protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less Diagnosis of Waldenström's disease or other conditions in which IgM M protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions Prior or current systemic therapy for multiple myeloma including steroids (with the exception of emergency use of a short course [maximum of 4 days] of steroids before randomization or of prior or current use of bisphosphonates) Radiation therapy within 30 days before randomization Plasmapheresis within 30 days before randomization Major surgery within 30 days before randomization (kyphoplasty is not considered major surgery) History of allergic reaction attributable to compounds containing boron or mannitol Peripheral neuropathy or neuropathic pain Grade 2 or higher Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-70.0, Refractory Multiple Myeloma Smoldering Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma Patients with multiple myeloma (stages I-III) will be eligible if they are either in response, or have stable disease Patients with smoldering myeloma are eligible if there is evidence of progressive disease requiring therapy (>= 25% increase in M protein levels or Bence Jones excretion; Hgb =< 10.5 g/dl; frequent infections; hypercalcemia; rise in serum creatinine above normal on two separate occasion) Patients with non-quantifiable monoclonal proteins are eligible provided they meet other for multiple myeloma, or smoldering myeloma, and they have evaluable or measurable disease by other (radiographic) means Unlimited prior chemotherapy regimens allowed KPS >= 70% Patients with Waldenstrom's macroglobulinemia are not eligible Less than 18 months since diagnosis No contraindication to the collection of a minimum of 4 x 10^6 CD34+ cells/kg by apheresis All patients must have signed a voluntary, informed consent in accordance with institutional and federal guidelines Adequate hepatic function as demonstrated by bilirubin, =< 1.5 mg/dl, and SGOT and SGPT < 2.5 x upper limits of normal | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Each patient must meet all of the following to be enrolled in the study Histologic confirmation of multiple myeloma Patients must have active multiple myeloma requiring first line treatment At least 18 years of age Female patient is either postmenopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e. hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and for 3 months after completing treatment Male patient agrees to use an acceptable method of contraception for the duration of the study and for 3 months after completing treatment Expected survival of at least 6 months Patients with abnormal kidney function, including patients on dialysis, are eligible if kidney insufficiency is secondary to multiple myeloma Patients must have adequate liver functions Patients may have received up to 2 weeks of high dose steroids. Prior steroid treatment for more than 2 weeks is allowed provided the treatment was given for neurological compromise Patients meeting any of the following are not to be enrolled in the study Serious medical or psychiatric illness likely to interfere with participation in this clinical study Patient had a myocardial infarction within 6 months of enrollment, history of cardiac disease, or clinical evidence of congestive heart failure Patient previously received 250 mg/m2 or more of doxorubicin (or equivalent for other anthracyclines) Patient is known to be human immunodeficiency virus (HIV)-positive (patients assessed to be at risk should be tested) Patient is known to be hepatitis B surface antigen-positive or has known active hepatitis C infection (patients assessed by the investigator to be at risk should be tested) Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment Patient has hypersensitivity to bortezomib, boron or mannitol, conventional doxorubicin HCL or the components of Doxil, or other study drugs Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-81.0, Multiple Myeloma Acute Renal Failure New diagnosis of multiple myeloma and progressive acute kidney failure. The former is defined as a bone marrow aspirate with > 10% plasma cells and a monoclonal light chain in the urine, plasma or renal tissue. The latter is defined as a serum Creatinine > 200 umol/L with a rise > 50 umol/L in the preceding 2 weeks despite correction of hypercalcemia , hypovolemia and metabolic acidosis as required in a patient with a normal size kidney on ultrasound <18 or > 81 years of age Obstruction on renal ultrasound (examination required) Use of intravenous contrast or non-steroidal anti-inflammatory drugs during the previous 2 weeks Prior treatment for myeloma Pregnancy Inability to sign informed consent | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients with multiple myeloma according to British Columbia Cancer Agency Stage IIA/B or IIIA/B according to Durie/Salmon Symptomatic or progressive disease Status of disease refractory disease after standard induction therapy OR relapse after standard induction therapy OR relapse after high-dose chemotherapy/stem cell transplantation OR patients with plasma cell leukemia Patients with measurable paraprotein in urine or serum or quantifiable bone marrow infiltration Written informed consent Age < 18 years Life expectancy of less than 3 months Intolerance to the study drugs No change or progressive disease after prior therapy with idarubicin or cyclophosphamide Cardiac insufficiency New York Heart Association (NYHA) grade 3 or 4 Acute infection Actually decompensated diabetes mellitus Total bilirubin > 3.0 mg/dl Pregnant or breast-feeding women Polyneuropathy grade 2 or higher | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-75.0, AIDS Related Lymphoma HIV positive with a high grade Ann Arbor stage I to IV untreated non-Hodgkin's lymphoma of B-cell origin confirmed by biopsy. The following histologies are eligible: *Burkitt's lymphoma, *diffuse large B-cell with standard histological diagnosis, *Burkitt-like and high grade large cell immunoblastic lymphoma with immunophenotyping CD20 positive Good and intermediate prognostic group (no more than one of the following prognostic factors: *CD4 below 100/µl, *history of opportunistic infection, *Karnofsky index below 60 percent or ECOG over 2) Written inform consent to participate Active viral hepatitis Pregnancy | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Age ≥ 18 years Expected survival ≥ 6 months Pre-study performance status of 0, 1, or 2 according to the World Health Organization (WHO) Newly diagnosed or relapsed/refractory myeloma with histologic confirmation of multiple myeloma by the Department of Pathology at University of Michigan Cancer Center (UMCC) Not more than 3 lines of therapy for myeloma for patients with relapsed disease Documented Stage II or III multiple myeloma (Durie and Salmon, 1975) prior to initiation of first line therapy At least 4 cycles of first line (for newly diagnosed patients) or salvage (for relapsed/refractory patients) prior therapy and in a plateau of at least partial response (Blade et al, 1999) for at least 2 determinations 6 weeks apart At least 21 days from day 1 of the last cycle and fully recovered from all toxicities associated with prior surgery, radiation treatments, chemotherapy, or immunotherapy Measurable M-proteins with greater than 1 g/dl serum monoclonal protein and/or greater than 0.5 g/24 hour urine light chain excretion Acceptable hematologic status within two weeks prior to patient registration, including Patients with impaired bone marrow reserve, as indicated by one or more of the following Platelet count < 100,000 cells/mm3 Hypocellular bone marrow Marked reduction in bone marrow precursors of one or more cell lines (granulocytic, megakaryocytic, erythroid) History of failed stem cell collection Myelodysplastic syndrome (MDS) or evidence of other than myeloma clonogenic abnormalities Prior radioimmunotherapy Prior anti-CD20 therapy Other than myeloma malignancy, except B-cell non-Hodgkin's lymphoma, basal and squamous cell carcinoma of the skin, and cervical and breast cancer in situ, unless patient is cancer free for > 3 years Central nervous system (CNS) involvement | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Myeloma, Plasma-Cell Lymphoma, Malignant Myeloproliferative Disorders Myelodysplastic Syndromes Waldenstrom's Macroglobulinemia Patients must be a candidate for unrelated donor stem cell transplantation and the donor and recipient must be 5/6 or 6/6 matched. In addition, patients must have one of the following histologically confirmed diagnosis : 1. Patients with previously treated AML (M0 M7 by FAB classification) who are in not in complete remission (CR) who are in second or later CR who have 5-30% persistent blasts in bone marrow following induction or salvage chemotherapy who have high-risk feature in first complete remission e.g. presence of Philadelphia chromosome or non-core-binding factor type of chromosomal abnormalities. 2. Patients with myelodysplastic syndromes and IPS int-1, int-2 or high-risk scores who are transfusion-dependent. 3. Patients with chronic myeloid leukemia who are in accelerated, blastic, or or chronic phase 4. Patients with acute lymphoblastic leukemia who are in first complete remission and have high risk disease [Ph' or t (4; 11) , WBC> 30,000, > 4 weeks to achieve CR] who are in second or greater CR who did not achieve a CR following induction or salvage therapy. 5. Patients with Hodgkin's or non-Hodgkin's lymphoma who are not curable with conventional chemotherapy and do not have any tumor larger than 5 centimeters in diameter. 6. Patients with myeloma or plasma cell neoplasms who are stage III at presentation Cardiac disease of symptomatic nature; < 25% ejection fraction. 2. Severe renal disease; creatinine > 2.O mg/dl or creatinine clearance < 40 ml/min. (Corrected for age) 3. Severe pulmonary disease < 60% normal (FEV1 & FVC). 4. Severe hepatic disease; bilirubin >2.0, and/or transaminase > 3 x normal corrected for age. 5. Karnofsky performance status of < 60%. 6. Patients with evidence of HIV infection by western blot. 7. Any conditions, in the opinion of the transplant team such as substance abuse, or severe personality disorder that would keep the patients from complying with the needs of the protocol and would markedly increase the morbidity and mortality from the procedure | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 55.0-90.0, Acute Lymphocytic Leukemia Ph+ ALL patients years or older Signed written informed consent CML in transformation Concomitant malignancy Previous treatment by Imatinib Severe organ condition | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Refractory Multiple Myeloma Relapsed Multiple Myeloma Multiple Myeloma Diagnosis of multiple myeloma based on standard diagnosis plasmacytomas on tissue biopsy; bone marrow plasmacytosis; monoclonal immunoglobulin spike on serum electrophoresis; lytic bone lesions Must have relapsed or relapsed/refractory disease years of age or older All baseline studies must be performed within 21 days of enrollment ECOG performance status of 0 to 2 Renal insufficiency (serum creatinine levels > 2mg/dL) Concomitant therapy medications that corticosteroids Peripheral neuropathy of Grade 3 or greater or painful Grade 2 Evidence of mucosal or internal bleeding and/or platelet refractory ANC < 1000 cells/mm3 Hemoglobin < 8.0 g/dL AST (SGOT and ALT) > 2 x ULN Intolerance to bortezomib or CC-5013 in the past or significant allergy to either compound, boron or mannitol Known hypersensitivity to thalidomide or the development of erythema nodosum Active infection or serious co-morbid medical condition | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Amyloidosis Histochemical diagnosis of amyloidosis as based on detection by polarizing microscopy of green birefringent material in Congo red-stained tissue specimens and immunohistochemical proof of AL 2. Measurable disease of AL amyloidosis as defined by one of the following Serum monoclonal protein >=1.0 g by protein electrophoresis >200 mg of monoclonal protein in the urine on 24 hour electrophoresis Serum immunoglobulin free light chain & >=10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio 3. ECOG performance status (PS) 0, 1, 2, or 3 4. >=18 years of age 5. The following laboratory values obtained <=14 days prior to registration Creatinine < = 3 mg/dL Absolute neutrophil count >=1000/microliter Platelet >=75000/microliter Hemoglobin > = 8.0 g/dL 6. Symptomatic organ involvement with amyloid to justify therapy. This could liver involvement, cardiac involvement, renal involvement, peripheral neuropathy grade 1, or soft tissue involvement. Must have more than purpura or carpal tunnel syndrome 7. Previously treated or untreated. No limit to prior therapy provided there is adequate residual organ function 8. Ability to provide informed consent 9. Anticipated life expectancy of at least 3 months 10. None of the following Pregnant women or women of reproductive ability who are unwilling to use effective contraception Nursing women | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Stage I Evidence of myeloma according to the of the British Columbia Cancer Agency (for the diagnosis, 2 of the 3 must be met) Evidence of paraprotein in the serum or urine Bone marrow infiltration with plasma cells which represent more than 10% of the nucleated cells Radiologically, at least one osteolytic lesion Asymptomatic patients with Stage I (Durie and Salmon) multiple myeloma Patients with more than one osteolytic lesion on conventional skeletal radiography Previous treatment with bisphosphonates bilirubin > 2.5 mg/dl Abnormal renal function as evidenced by: A calculated creatinine clearance < 30 ml/minute. Creatinine clearance (CrCl) is calculated using the Cockcroft-Gault formula CrCl= [140-age(years)] x weight(kg)/[72xserumcreatinine(mg/dL)] X {0.85 for female patients} Patients with other malignant diseases or severe concomitant diseases Potentially fertile patients who are not using a reliable and appropriate method of contraception Pregnancy or breast-feeding Participation in another clinical study with an investigational drug within 12 weeks of study entry Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Pleural Effusion Clinical diagnosis of pleural effusion Pleural effusion proved by chest sonography Conditions for which thoracentesis are contraindicated Pregnancy | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-75.0, Multiple Myeloma Patients meeting the Durie and Salmon for initial diagnosis of multiple myeloma, requiring therapy and meeting one of the following After initial therapy in either first complete or partial remission or no objective response After achieving initial response and later disease progression, patient will be eligible after subsequent therapy upon achievement of either complete or partial response Is not eligible or has refused any protocols of higher priority years of age Adequate organ function defined as Hematologic: hemoglobin ≥ 8 gm/dl (untransfused), white blood cells (WBC) ≥ 3000/μl, absolute neutrophil count (ANC) ≥ 1500/μl, platelets ≥ 100,000/μl (untransfused) Cardiac: no active ischemia, left ventricular ejection fraction > 45% by MUGA scan Hepatic: bilirubin < 2.0 mg/dl, ALT < 3x the upper limit of normal Pulmonary: FEV1-Forced Expiratory Volume in One Second AND Forced vital capacity (FVC) >50% predicted and Carbon Monoxide Diffusing Capacity (DLCO) (corrected) > 50% predicted Patients will be ineligible if they have advanced myeloma refractory and unresponsive to salvage chemotherapy regimens Female patients who are pregnant (positive b-HCG) or breastfeeding will be excluded from study entry. In addition fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment, particularly after thalidomide will also be excluded from study entry | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Must understand and voluntarily sign an informed consent form. 2. Must be > or = to 18 years of age at the time of signing the informed consent form. 3. Must be able to adhere to the study visit schedule and other protocol requirements. 4. Must be diagnosed with multiple myeloma that is progressing after at least 2 cycles of anti-myeloma treatment or that has relapsed with progressive disease after treatment. 5. Subjects may have been previously treated with thalidomide and/or radiation therapy. In addition, radiation therapy initiated prior to or at baseline (Day 1) may be given concurrently with study therapy, provided that all other are satisfied. 6. Measurable levels of myeloma paraprotein in serum (>/=0.5 g/dL) or urine (>/=0.2 g excreted in a 24-hour collection sample). 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. 8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study medication Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. Pregnant or lactating females. 3. Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. Any of the following laboratory abnormalities: 1. Absolute neutrophil count (ANC) <1,000 cells/mm3 (1.0 x 109/L) 2. Platelet count <75,000/mm3 (75 x 109/L) for subjects in whom <50% of the bone marrow nucleated cells are plasma cells. 3. Platelet count <30,000/mm3 (30x109/L) for subjects in whom >/= 50% of bone marrow nucleated cells are plasma cells. 4. Serum creatinine >2.5 mg/dL (221 mmol/L) 5. Serum glutamic oxaloacetic transaminase (SGOT, aspartate transaminase [AST]) or serum glutamic pyruvic transaminase (SGPT, alanine transaminase [ALT]) >3.0 x upper limit of normal (ULN) 6. Serum total bilirubin >2.0 mg/dL (34 mmol/L) 5. Prior history of malignancies other than multiple myeloma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for >/= 1 year. 6. Known hypersensitivity to thalidomide or dexamethasone. 7. Prior history of uncontrollable side effects to dexamethasone therapy. 8. The development of a desquamating rash while taking thalidomide. 9. Use of any standard/experimental anti-myeloma drug therapy within 28 days of the initiation of study drug treatment or use of any experimental non-drug therapy (e.g., donor leukocyte/mononuclear cell infusions) within 56 days of the initiation of study drug treatment | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-75.0, Amyloidosis Blood and Marrow Transplant (BMT) Criteria:1. Primary amyloidosis 2. Age < 75 years. 3. Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 4. Patients who have undergone bone marrow transplantation previously will not be eligible. 5. Patients must have a Karnofsky performance status greater than 70%. 6. Patients must have a serum creatinine less than 2 mg/dl or creatinine clearance greater than 30 ml/min, bilirubin less than 2 mg/dl, transaminases less than two times normal, left ventricular ejection fraction >45% on echocardiography, cardiac index > 1.8 liters/min/m^2 and pulmonary function tests demonstrating FEV1 and DLCO > 60%. 7. Patients must be HIV negative. 8. Pregnant or lactating women will not be eligible to participate. 9. Patients must provide signed informed consent. 10. Patients with multiple myeloma and amyloid are eligible prior blood or marrow transplant | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-65.0, Multiple Myeloma Recently diagnosed MM according to the of the South West Oncology Group (SWOG) Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion < 65 years of age Ability to give signed informed consent Secretion of a measurable monoclonal spike (> 10 g/l in the serum or 0.2 g/24h in the urine) Negative pregnancy test at (if necessary) Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone ECOG performance status > 2 History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ) Life expectancy < 2 months Confirmed amyloidosis Positive HIV serology Serious psychiatric item in the history Renal failure requiring dialysis Uncontrolled diabetes, contra-indicating the use of corticosteroids Peripheral neuropathy National Cancer Institute (NCI) grade > 2 (Annex 5) Clinical signs of heart failure or coronary heart disease | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients must have newly diagnosed MM confirmed by the presence of bone marrow plasmacytosis with > 10 percent plasma cells, sheets of plasma cells, or biopsy-proven plasmacytoma. Patients must have Durie-Salmon Stage IIA-B or IIIA-B. Patients with non-secretory myeloma are eligible. (These patients will not be included in the analysis of response rates, but will be assessed for toxicity and survival) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3 ≥ 18 years of age Signed informed consent form Expected survival of greater than 8 weeks Capable of swallowing study medication tablets Capable of following directions regarding taking study medication, or has a daily care provider who will be responsible for administering study medication Patients will be eligible for study even if they lack socioeconomic access to autologous transplantation. (These patients will be identified prior to randomization so as not to confound study results) All patients (in the event that they are randomized to the thalidomide/dexamethasone arm) must agree to take part in the "System for Education and Prescribing Safety" (S.T.E.P.S.)™. They must sign a separate informed consent for this program Elevated direct bilirubin > 2 mg/dl Serum alanine aminotransferase (ALT) or serum aspartate aminotransferase (AST) > 2 times the upper limit of normal (ULN) Absolute neutrophil count (ANC) <1000/mL, unless felt to be secondary to myeloma Ongoing radiation therapy, or radiation therapy within 3 weeks prior to first treatment, unless the acute side effects associated with such therapy are resolved Prior treatment for multiple myeloma Prior bisphosphonate use is allowed but they must be discontinued before starting treatment Concurrent uncontrolled serious infection Patients with peripheral (sensory) neuropathy, grade 3 or higher Life-threatening illness (unrelated to tumor) History of any other and cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Multiple Myeloma Patients with multiple myeloma in need of treatment Previous treatment against multiple myeloma Need of high dose chemotherapy with autologous stem cell support Women in fertile age Psychiatric disease or mental reduction leading to lack of cooperation Lack of consent Life expectancy below 3 months Active cancer of other etiology | 0 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 0.0-999.0, Multiple Myeloma untreated myeloma patients age >65 years of age or younger but excluded from transplant procedure Durie & Salmon stage II or III myeloma and measurable disease Patients agreed to use contraception other cancer psychiatric disease and any grade 2 peripheral neuropathy | 1 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, Multiple Myeloma Patients eligible for this trial are those diagnosed with multiple myeloma by standard and treated with HDCT and ASCT on protocols at Washington University School of Medicine. Following HDCT and ASCT patients must have: 1. M-component (IgG or IgA) with persistent measurable paraprotein, or >=2 g monoclonal protein in 24 hr urine specimen or patients with an abnormal serum kappa/lambda ratio and a level of kappa or lambda light chain > 10 mg/dl. 2. >=90 days and <= 120 days post transplant 3. Laboratory values less than or equal to 2 weeks prior to initiation of treatment Absolute neutrophil count (ANC) greater than or equal 1.5 x 10^9/L Platelets (PLT) greater than or equal to 100 x 10^9/L Hemoglobin (Hgb) greater than or equal to 9 g/dL Serum creatinine less than or equal to 1.5 upper limit of normal (ULN) Serum bilirubin less than or equal to 1.5 ULN Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) less than or equal to 3.0 x ULN Negative for proteinuria based on dip stick reading OR, if documentation of +1 result for protein on dip stick reading, then total urinary albumin ≤ 500 mg and measured creatinine clearance (CrCl) greater than or equal to 50 mL/min from a 24-hour urine collection 4. A negative pregnancy test 48 hours prior to study treatment and must not be lactating if they are females of childbearing age. 5. Ability to understand and the willingness to sign a written informed consent document in accordance with the guidelines of the Washington University Human Studies Committee. 6. Age greater than or equal to 18 years old. 7. ECOG performance status less than or equal to 2 Receiving any other investigational agents. 2. Receiving concurrent steroids with a dose equivalent of prednisone of >= 150 mg/month. 3. Female patients who are pregnant or breast feeding, or adults of reproductive potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial in both sexes. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. 4. Biopsy proven amyloidosis. 5. Patients with a history of another primary malignancy within less than or equal to 5 years, with the exception of inactive basal or squamous cell carcinoma of the skin. 6. Prior chemotherapy less than or equal to 3 weeks prior to registration and/or randomization. Patients must have recovered from all therapy-related toxicities. 7. Prior biologic or immunotherapy less than or equal to 2 weeks prior to registration and/or randomization. Patients must have recovered from all therapy-related toxicities. 8. Prior full field radiotherapy less than or equal to 4 weeks or limited field radiotherapy less than or equal to 2 weeks prior to randomization. Patients must have recovered from all therapy-related toxicities. 9. Pleural effusion or ascites that cause respiratory compromise (greater than or equal to CTC grade 2 dyspnea). 10. Major surgery (i.e. laparotomy) less than or equal to 4 weeks prior to randomization. Minor surgery less than or equal to 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities. 11. Patients who have received investigational drugs less than or equal to 4 weeks prior to registration and/or randomization. 12. Prior therapy with anti-vascular endothelial growth factor (VEGF) agents. 13. Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen Unstable angina pectoris Symptomatic congestive heart failure Myocardial infarction less than or equal to 6 months prior to registration and/or randomization Serious uncontrolled cardiac arrhythmia QTc interval > 450 milliseconds in males or > 470 milliseconds in females Uncontrolled diabetes Active or uncontrolled infection Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung 14. Acute or chronic liver disease (e.g. hepatitis, cirrhosis). 15. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PTK787/ZK 222584 (i.e., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, bowel obstruction, or inability to swallow the tablets). 16. Patients with confirmed diagnosis of human immunodeficiency virus (HIV) infection are excluded at the investigator's discretion if he/she feels that: a potential drug interaction between PTK787/ZK 222584 and any of the patient's anti-HIV medications could influence the efficacy of the anti-HIV medication, or it may place the patient at risk due to the pharmacologic activity of PTK787/ZK 222584. 17. Patients who are taking therapeutic warfarin sodium (Coumadin) or similar oral anticoagulants that are metabolized by the cytochrome P450 system. Heparin is allowed. 18. Patients unwilling to or unable to comply with the protocol | 2 |
64yo woman with multiple myeloma, s/p allogeneic transplant with recurrent disease and with systemic amyloidosis (involvement of lungs, tongue, bladder, heart), on hemodialysis for ESRD who represents for malaise, weakness, and generalized body aching x 2 days. She was admitted last week with hypercalcemia and treated with pamidronate 30mg, calcitonin, and dialysis. Patient was Initially treated with melphalan and prednisone, followed by VAD regimen, and autologous stem cell transplant. With relapse of her myeloma, she received thalidomide velcade and thalidomide, which were eventually also held due to worsening edema and kidney function. | eligible ages (years): 18.0-999.0, End-Stage Renal Disease Muscle Weakness end-stage renal disease on hemodialysis for 3 or more months inadequate dialysis; Kt/V <1.2 nonadherent to dialysis treatments; missing >2 dialysis sessions in the month prior to screening catabolic state; HIV with opportunistic infection in the last 3 months, malignancy, or infection requiring intravenous antibiotics within 2 months prior to screening unable to give informed consent active intravenous drug use contraindications to resistance exercise; myocardial infarction within 6 months, active angina, uncompensated congestive heart failure, orthopedic or musculoskeletal limitations | 0 |
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