|Phase III||Treatment||Closed||18 to 70||NCI||NCI-2009-00439|
CDR0000434845, CALGB 100104/ECOG 100104, CALGB-100104, U10CA031946, ECOG-CALGB-100104, NCT00114101
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.
- 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
- Absolute neutrophil count >= 1,000/mm^3;
- Platelet count >= 100,000/mm^3
- 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
- Creatinine clearance >= 40 mL/min;
- Creatinine =< 2 mg/dL
- LVEF >= 40% by MUGA or echocardiogram
- 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 Lead Organizations/Sponsors
National Cancer Institute
|Philip McCarthy||Principal Investigator|
|Rebecca and John Moores UCSD Cancer Center|
|Barbara A Parker||Ph: 858-822-5354|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00114101
ClinicalTrials.gov processed this data on October 17, 2013
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