NCT00305812CompletedPhase 2
A Randomized Phase II Dose Finding Study of Revlimid™ and Melphalan in Patients With Previously Untreated Multiple Myeloma
NCIC Clinical Trials Group28 sites in 1 country51 target enrollmentStarted: March 9, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- NCIC Clinical Trials Group
- Enrollment
- 51
- Locations
- 28
- Primary Endpoint
- Incidence of dose-limiting toxicity within first 3 courses of treatment
Study Overview
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. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving lenalidomide together with melphalan may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying the side effects and best dose of lenalidomide when given together with melphalan and to see how well they work in treating patients with multiple myeloma.
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 undergo future autologous stem cell transplantation.
Secondary
- Characterize the toxicity profile of lenalidomide in combination with melphalan.
- Determine tumor response in these patients after 2 and 12 courses of induction therapy with lenalidomide and melphalan and after 6 months of maintenance therapy with dexamethasone.
- Determine progression-free and overall survival of these patients.
- Determine time to dose modification and time to dose discontinuation in these patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of dose-limiting toxicity within first 3 courses of treatment
Secondary Outcomes
- Overall survival
- Time to progression
- Toxicity
- Disease response after 2 courses, 6 courses, 12 courses, and 6 months of maintenance therapy
- Duration of disease-free interval
- Time to dose modification
- Time to dose discontinuation
Investigators
Study Sites (28)
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