Neoplasms

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Multiple Myeloma

Neoplasms, Plasma Cell

Neoplasms by Histologic Type

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Paraproteinemias

Blood Protein Disorders

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Anti-Inflammatory Agents

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All Drugs and Chemicals

Dexamethasone

Lenalidomide

Dexamethasone acetate

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle

Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.

Lenalidomide 15mg

Lenalidomide 25mg

Nikhil C Munshi, M.D.

This is a research study to evaluate two different Lenalidomide doses (15 mg vs. 25 mg) in combination with low dose dexamethasone in patients with relapsed multiple myeloma.

The investigators propose to use the need for dose reduction as a criterion to judge tolerability from various causes. In the veteran population which predominantly is in the older age category with number of co-morbidities, a lower dose regimen may be safer and advantageous.

This study expects to enroll approximately 80 subjects from participating VA sites across the nation.

The investigators will evaluate the safety of the two dose regimens by comparing frequency of dose reductions. The investigators will also measure how long the responses last with each dose.

Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.

At the time of enrollment, one-half of the subjects will be chosen at random to receive the 15 mg Lenalidomide dose and the other half will take the 25 mg dose regimen of Lenalidomide. Depending on lenalidomide treatment assignment, subjects will receive either 15 mg p.o. q.d. or 25 mg p.o. q.d. for days 1-21 of a 28 day cycle. In addition, dexamethasone (40 mg) will be added once a week (Days 1, 8, 15 and 22) to the Lenalidomide regimen, with a dose reduction on the same schedule if the patient cannot tolerate the higher dose of dexamethasone. ASA (81 or 325mg) will be given daily for anticoagulation prophylaxis. Patients intolerant to ASA may use low molecular weight heparin. Lovenox is recommended. Coumadin will be allowed provided the patient is fully anticoagulate with INR 2.0 to 2.5.

Primary Objective:

• Evaluate the frequency of dose reductions in two different lenalidomide dose regimens.

Secondary Objectives:

* Evaluate the efficacy of two different lenalidomide dose regimens in patients with multiple myeloma using the EBMT and IMWG criteria.
* Evaluate the duration of response of 15 mg Lenalidomide and 25 mg of Lenalidomide when used in combination with Low Dose Dexamethasone.
* Evaluate the safety of 15 mg and 25 mg of Lenalidomide regiments when in combination with dexamethasone.
* Explore blood and cellular levels of angiogenic factors, cytokines, and adhesion molecules.

Study to Evaluate Two Lenalidomide Dose Regimens With Low Dose Dexamethasone for the Treatment Relapsed Multiple Myeloma

A Controlled, Parallel-Group, Randomized, Open-Label Study to Evaluate Two Lenalidomide Dose Regimens When Used in Combination With Low Dose Dexamethasone for the Treatment of Subjects With Relapsed Multiple Myeloma

Type, frequency, severity and timing of adverse events and their relationship to combination therapy with lenalidomide plus dexamethasone.

SAE Grade 3 indicates a severe or medically significant but not immediately life threatening; hospitalization or prolongation of hospitalization; disabling; limiting self care ADL SAE Grade 4 indicates a life-threatening consequences; urgent intervention indicated.

SAE Grade 5 Death related to AE.

Number of days between the first day of the first cycle to best M-protein response, at least Minimal Response or higher (Partial Response, Very Good Partial Response, near Complete Response, Complete Response).

Celgene Corporation

Kansas City Veteran Affairs Medical Center

VA Pittsburgh Healthcare System

VA Greater Los Angeles Healthcare System

Michael E. DeBakey VA Medical Center

Edward Hines Jr. VA Hospital

Boston VA Research Institute, Inc.

Principal Investigator -- Coordinating site

Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Lenalidomide 25mg: Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle

Subjects will receive oral lenalidomide 15mg once daily for days 1-21 out of a 28 cycle

Lenalidomide 15mg: Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.

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