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Clinical Trials/NCT00305812
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
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

Sponsor Class
Network
Responsible Party
Sponsor

Study Sites (28)

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