Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma
Multiple Myeloma and Plasma Cell Neoplasm
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed multiple myeloma 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 ≥ 10% plasmacytosis Bone marrow < 10% plasma cells but with ≥ 1 bony lesion AND meets the M-protein criteria Ineligible for stem cell transplantation due to any of the following: Advanced age Comorbid illness Patient preference Previously untreated disease Measurable (i.e., quantifiable) serum M-component of IgG, IgA, IgD, or IgE at initial diagnosis OR, if only light-chain disease is present (urine M-protein only), urinary excretion of light-chain protein (Bence Jones) ≥ 1.0 g/24 hours at initial diagnosis No nonsecretory myeloma PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy ≥ 12 months Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 150,000/mm^3 Creatinine ≤ 3 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN AST and/or ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use 2 methods of effective contraception during and for 4 weeks after completion of study treatment No other malignancies within the past 5 years, except adequately treated nonmelanoma skin cancer or curatively treated in situ cancer of the cervix No hypersensitivity to thalidomide or its components, including the development of a desquamating rash No other serious illness or medical condition that would preclude study participation No history of significant neurologic or psychiatric disorder that would preclude informed consent No known HIV positivity No pre-existing cardiovascular conditions and/or symptomatic cardiac dysfunction, including any of the following: Significant cardiac event (including symptomatic heart failure or angina) within 3 months prior to randomization Any cardiac disease that increases risk for ventricular arrhythmia History of ventricular arrhythmia that was symptomatic or required treatment, including any of the following: Multifocal premature ventricular contractions Bigeminy Trigeminy Ventricular tachycardia/fibrillation/flutter/arrhythmia NOS PRIOR CONCURRENT THERAPY: No prior chemotherapy or corticosteroids for the treatment of multiple myeloma Prior corticosteroids for the treatment of hypercalcemia or spinal cord compression allowed provided maximum levels have not been reached (i.e.,< 120 mg for dexamethasone or < 792 mg for prednisone) Prior radiotherapy to single sites for pain control or local plasmacytoma allowed Prior or concurrent bisphosphonates allowed At least 28 days since prior investigational anticancer agents or therapy No concurrent corticosteroids above physiologic replacement doses Concurrent radiotherapy to sites of active myeloma with pain or neurologic compromise allowed No concurrent filgrastim (G-CSF) on day 1 of course 1 No other concurrent anticancer therapy No other concurrent investigational therapy
Sites / Locations
- Tom Baker Cancer Centre - Calgary
- Cross Cancer Institute at University of Alberta
- British Columbia Cancer Agency - Centre for the Southern Interior
- Moncton Hospital
- Nova Scotia Cancer Centre
- Margaret and Charles Juravinski Cancer Centre
- London Regional Cancer Program at London Health Sciences Centre
- Algoma District Cancer Program at Sault Area Hospital
- Princess Margaret Hospital
- Humber River Regional Hospital - Weston
- Hopital Charles Lemoyne
- Hopital Notre-Dame du CHUM
- McGill Cancer Centre at McGill University
- Allan Blair Cancer Centre at Pasqua Hospital