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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI, Other	CDR0000533873 FHCRC-2135.00, NCT00445692

Trial Description

Summary

RATIONALE: Biological therapies, such as lenalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, 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 dexamethasone and clarithromycin may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying the side effects and how well giving lenalidomide together with dexamethasone and clarithromycin works in treating patients who have undergone autologous or syngeneic stem cell transplant for multiple myeloma.

Further Study Information

OBJECTIVES:

Primary

• Determine the toxicity of maintenance therapy comprising lenalidomide, clarithromycin, and dexamethasone in patients who have undergone autologous or syngeneic hematopoietic stem cell transplantation for multiple myeloma.

Secondary

• Determine the median time to disease progression in patients treated with this regimen.

• Determine the survival of patients treated with this regimen.

OUTLINE: This is an open-label study.

Patients receive oral clarithromycin twice daily and oral dexamethasone once a week. Treatment continues for up to 1 year* in the absence of disease progression or unacceptable toxicity. Patients also receive oral lenalidomide on days 1-14. Treatment with lenalidomide repeats every 21 days in the absence of unacceptable toxicity or disease progression.

NOTE: *After 1 year of treatment, dexamethasone is tapered for an additional 4 weeks.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma

• Received high-dose (≥ 140 mg/m²) melphalan with autologous or syngeneic peripheral blood stem cell or bone marrow transplantation (for any stage disease) 30-120 days ago

PATIENT CHARACTERISTICS:

• Karnofsky performance status 70-100%

• Absolute granulocyte count > 1,500/mm³

• Platelet count > 50,000/mm³ (independent of transfusion)

• Bilirubin ≤ 2 mg/dL (unless history of Gilbert's disease)

• ALT and AST ≤ 2.5 times upper limit of normal

• Creatinine clearance ≥ 25 mL/min

• LVEF ≥ 45% immediately pretransplant

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use 2 methods of effective contraception during and for 30 days after completion of study therapy

• No cardiovascular disease, including any of the following:

• Congestive heart disease with transplant

• History of myocardial infarction

• History of coronary artery disease

• No untreated systemic infection

• No allergies to lenalidomide, clarithromycin, or dexamethasone

• No peripheral neuropathy ≥ grade 3

• No history of uncontrollable side effects secondary to dexamethasone

• No HIV positivity

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Lenalidomide or clarithromycin with steroids allowed prior to transplantation provided patient responded to these drugs

• No concurrent participation in another transplantation clinical trial that is also evaluating long-term disease-free survival or overall survival

• No other concurrent anticancer therapy

Trial Contact Information

Trial Lead Organizations/Sponsors

Fred Hutchinson Cancer Research Center

Leona A. Holmberg

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00445692
Information obtained from ClinicalTrials.gov on October 25, 2009

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