Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: 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.

PURPOSE: 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 (group two closed as of 12/17/09).

Further Study Information

OBJECTIVES:

Primary

• 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 (arm II closed as of 12/17/09).

Secondary

• Compare the rate of complete response in patients treated with these regimens (arm II closed as of 12/17/09).

• Compare the progression-free and overall survival of patients treated with these regimens (arm II closed as of 12/17/09).

• 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: Mobilization of autologous peripheral blood stem cells will be performed according to institutional guidelines. Stem cells may be collected at any time prior to transplant.

• Autologous PBSC transplantation (PBSCT): Approximately 2-4 weeks after PBSC collection, patients receive melphalan IV either over 30-60 minutes on day -2 or as a divided dose over two days on days -3 and -2 or days -2 and -1. Patients undergo autologous PBSCT on day 0. Patients receive G-CSF SC once daily after day 0 but before 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 β2 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 II closed as of 12/17/09).

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

• Arm II (closed as of 12/17/09): Beginning between day 100-110, patients receive oral placebo once daily. Patients who have not yet met the study endpoint receive oral lenalidomide as in arm I at the discretion of treating physician.

In both arms, treatment continues in the absence of disease progression or unacceptable toxicity (arm II closed as of 12/17/09) .

NOTE: *The maintenance dose is increased to a maximum dose of 3 pills over 3-6 months.

Treatment assignments were unblinded on 12/17/2009. As of 12/17/2009, no more patients will be randomized between lenalidomide and placebo.

After completion of study treatment, patients are followed every 3 months for 4 years, every 6 months for 5 years, and then annually for 6 years.

PROJECTED ACCRUAL: A total of 538 will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Active disease requiring treatment

• Durie-Salmon Stage I, II, or III

• Stable disease or responsive after ≥ 2 months of any 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

PATIENT CHARACTERISTICS:

Age

• 18 to 70

Performance status

• ECOG 0-1

Life expectancy

• Not specified

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

Other

• 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 CONCURRENT THERAPY:

• Prior thalidomide or lenalidomide allowed provided treatment duration was ≤ 12 months

• No prior bone marrow or peripheral blood stem cell transplantation

• No prior solid organ transplantation

• Prior therapy allowed provided treatment duration was ≤ 12 months

• No more than two prior regimens (not including dexamethasone alone)

• No concurrent pegfilgrastim

• Peripheral blood stem cell (PBSC) 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

• PBSC collection may occur before or after registration

Trial Contact Information

Trial Lead Organizations/Sponsors

Cancer and Leukemia Group B

Philip L. McCarthy

Study Chair

Kenneth C. Anderson

Study Chair

Edward Allen Stadtmauer

Study Chair

U.S.A.
California
	San Diego
	Rebecca and John Moores UCSD Cancer Center
		Barbara A Parker	Ph: 858-822-5354
			Email: baparker@ucsd.edu

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00114101
Information obtained from ClinicalTrials.gov on November 20, 2012

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