S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis
Multiple Myeloma, Plasma Cell Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring primary systemic amyloidosis, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: 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 criteria 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 Histologically confirmed primary systemic amyloidosis No senile, secondary, localized, dialysis-related, or familial amyloidosis No severe cardiac involvement No pre-exertional syncope, ventricular arrhythmia, or symptomatic pleural effusions associated with cardiac involvement Light Chain Deposition Disease alone or in combination with multiple myeloma meeting the following criteria: Deposition of granular material containing free light chains/immunoglobulins that did not bind Congo red Evidence of plasma cell dyscrasia (i.e., monoclonal gammopathy in the serum or urine by immunofixation electrophoresis and/or clonal plasmacytosis) on bone marrow biopsy by immunohistochemistry and/or elevated serum-free light chain concentration Must have been diagnosed within the past year Concurrent enrollment in the myeloma repository protocol SWOG-S0309 must be offered PATIENT CHARACTERISTICS: Age 18 and over (patients with amyloidosis only OR patients with amyloidosis and multiple myeloma OR patients with multiple myeloma only with poor renal function) OR 70 and over (patients with multiple myeloma only with or without poor renal function) Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2.5 times upper limit of normal (ULN) SGOT or SGPT no greater than 2.5 times ULN Renal No hemodialysis within 2 hours of melphalan or stem cell infusion Cardiovascular See Disease Characteristics Hemodynamically stable (i.e., systolic blood pressure > 90 mm Hg in a lying position within the past 42 days) No myocardial infarction within the past 6 months No congestive heart failure No arrhythmia refractory to medical therapy LVEF greater than 45% by echocardiogram or MUGA Pulmonary See Disease Characteristics No history of chronic obstructive or chronic restrictive pulmonary disease Pulmonary function studies (e.g., FEV_1 and FVC) at least 50% of predicted DLCO at least 50% of predicted Normal high resolution CT scan of the chest and acceptable arterial blood gases (i.e., PO_2 greater than 70) required for patients unable to complete pulmonary function tests due to bone pain or fracture Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Multiple myeloma patients receiving thalidomide must use 2 methods of effective contraception for at least 4 weeks before, during, and for at least 4 weeks after discontinuation of thalidomide HIV negative No other concurrent significant medical condition No concurrent uncontrolled life-threatening infection 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 PRIOR CONCURRENT THERAPY: Biologic therapy See Disease Characteristics Chemotherapy See Disease Characteristics Prior cumulative melphalan dose no more than 200 mg No other concurrent chemotherapy Endocrine therapy See Disease Characteristics No concurrent hormonal therapy Radiotherapy No concurrent radiotherapy Surgery Not specified Other Recovered from prior therapy Prior or concurrent bisphosphonates allowed
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- University of California Davis Cancer Center
- Mountain States Tumor Institute at St. Luke's Regional Medical Center
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Tammy Walker Cancer Center at Salina Regional Health Center
- Boston University Cancer Research Center
- Barbara Ann Karmanos Cancer Institute
- Josephine Ford Cancer Center at Henry Ford Hospital
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- Billings Clinic - Downtown
- Bozeman Deaconess Cancer Center
- St. James Healthcare Cancer Care
- Big Sky Oncology
- Great Falls Clinic - Main Facility
- Sletten Cancer Institute at Benefis Healthcare
- Northern Montana Hospital
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology at KRMC
- Guardian Oncology and Center for Wellness
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Cleveland Clinic Taussig Cancer Center
- Legacy Good Samaritan Hospital & Comprehensive Cancer Center
- Northwest Cancer Specialists at Rose Quarter Cancer Center
- Thompson Cancer Survival Center
- Fred Hutchinson Cancer Research Center
- Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
- University Cancer Center at University of Washington Medical Center
- Rocky Mountain Oncology
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Experimental
Treatment
MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion >/= 3.5 x 10^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year.