Status:
COMPLETED
Lenalidomide and Melphalan in Treating Patients With Previously Untreated Multiple Myeloma
Lead Sponsor:
NCIC Clinical Trials Group
Conditions:
Multiple Myeloma and Plasma Cell Neoplasm
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Lenalidomide may stop the growth of multiple myeloma by blocking blood flow to the cancer. It may also stimulate the immune system in different ways and stop cancer cells from growing. Drug...
Detailed Description
OBJECTIVES: Primary * Evaluate the tolerability of 2 different doses of lenalidomide when administered with melphalan in patients with previously untreated multiple myeloma who are not planning to u...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2008
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00305812
Start Date
March 9 2006
End Date
June 30 2008
Last Update
August 4 2023
Active Locations (14)
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1
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
2
Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada, T6G 1Z2
3
British Columbia Cancer Agency - Centre for the Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
4
Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8