Lenalidomide in Treating Patients Who Are Undergoing Autologous Stem Cell Transplant for Multiple Myeloma

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 to 70NCINCI-2009-00439
CDR0000434845, CALGB 100104/ECOG 100104, CALGB-100104, U10CA031946, P30CA014236, ECOG-CALGB-100104, NCT00114101

Trial Description


This randomized phase III trial is studying lenalidomide to see how well it works compared to a placebo in treating patients who are undergoing autologous stem cell transplant for multiple myeloma. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may stop or slow the return of cancer. It is not yet known whether lenalidomide is more effective than a placebo when given after autologous stem cell transplant in treating multiple myeloma.

Further Study Information


I. Compare the efficacy of lenalidomide vs placebo as maintenance therapy after autologous stem cell transplantation, in terms of prolonging time to disease progression, in patients with multiple myeloma.


I. Compare the rate of complete response in patients treated with these regimens.

II. Compare the progression-free and overall survival of patients treated with these regimens.

III. Determine the feasibility of long-term treatment with lenalidomide in these patients

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.

PERIPHERAL BLOOD STEM CELL (PBSC) MOBILIZATION: Patients receive high-dose cyclophosphamide IV over 2-3 hours on day 1 OR IV over 1 hour every 3 hours three times on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on day 5 and continuing until PBSC collection is complete. Patients then undergo leukapheresis for collection of PBSC.

AUTOLOGOUS PBSC TRANSPLANTATION (PBSCT): Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV over 30-60 minutes on day -2. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily beginning on day 5 and continuing until blood counts recover.

MAINTENANCE THERAPY*: Approximately 90-100 days after completion of autologous PBSCT, patients undergo restaging. Patients with disease progression are removed from the study. Patients with responding or stable disease are stratified according to levels of beta2 microglobulin at baseline ( >= 2.5 mg/dL vs normal), prior thalidomide (yes vs no), and prior lenalidomide (yes vs no). Patients are randomized to 1 of 2 maintenance treatment arms.

ARM I: Beginning between day 100-110, patients receive oral lenalidomide once daily.

ARM II: Beginning between day 100-110, patients receive oral placebo once daily.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.

[Note: *The maintenance dose is increased to a maximum dose of 3 pills over 3-6 months]

After completion of study treatment, patients are followed every 3 months for 4 years and every 6 months thereafter.

Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of multiple myeloma:
  • Active disease requiring treatment;
  • Durie-Salmon Stage I, II, or III
  • Stable disease or responsive after >= 2 months of induction therapy initiated within the past year
  • No prior disease progression after initial therapy
  • Patients with smoldering myeloma are eligible provided disease has progressed to >= stage I
  • Performance status:
  • ECOG 0-1
  • Hematopoietic:
  • Absolute neutrophil count >= 1,000/mm^3;
  • Platelet count >= 100,000/mm^3
  • Hepatic:
  • Hepatitis B surface antigen negative;
  • Hepatitis C negative;
  • Bilirubin =< 2 mg/dL;
  • AST =< 3 times upper limit of normal (ULN);
  • Alkaline phosphatase =< 3 times ULN
  • Renal:
  • Creatinine clearance >= 40 mL/min;
  • Creatinine =< 2 mg/dL
  • Cardiovascular:
  • LVEF >= 40% by MUGA or echocardiogram
  • Pulmonary:
  • DLCO > 50% of predicted;
  • No symptomatic pulmonary disease
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective double-method contraception
  • HIV negative
  • No uncontrolled diabetes mellitus
  • No serious active infection
  • Prior thalidomide or lenalidomide allowed provided treatment duration was =< 12 months
  • No prior bone marrow or peripheral blood stem cell transplantation
  • No concurrent pegfilgrastim
  • No prior solid organ transplantation
  • Prior therapy allowed provided treatment duration was =< 12 months
  • Peripheral blood stem cell collection of >= 2 x 10^6 CD34+ cells/kg (patient body weight) and preferably 5 x 10^6 cells/kg (patient body weight);
  • Stem cells may be collected at any time prior to transplant

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Philip McCarthy, Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00114101
    ClinicalTrials.gov processed this data on April 09, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.