Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Lenalidomide, Dexamethasone, and Clarithromycin in Treating Patients Who Have Undergone Stem Cell Transplant for Multiple Myeloma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 and over NCI FHCRC-2135.00 6435, NCT00445692

Objectives

Primary

1. 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

1. Determine the median time to disease progression in patients treated with this regimen.
2. Determine the survival of patients treated with this regimen.

Entry 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

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

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

Expected Enrollment

A total of 30 patients will be accrued for this study.

Outcomes

Toxicity
Time to disease progression
Overall survival

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.]

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

Leona Holmberg, MD, PhD, Principal investigator		Ph: 206-667-6447 Email: lholmber@fhcrc.org

U.S.A.
Washington
	Seattle
	Fred Hutchinson Cancer Research Center
		Leona Holmberg, MD, PhD	Ph:  206-667-6447
			Email: lholmber@fhcrc.org
	Seattle Cancer Care Alliance
		Clinical Trials Office - Seattle Cancer Care Alliance	Ph:  800-804-8824

Registry Information
Official Title		Maintenance Therapy with Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma
Trial Start Date		2007-01-10
Trial Completion Date		2018-01-10 (estimated)
Registered in ClinicalTrials.gov		NCT00445692
Date Submitted to PDQ		2007-01-29
Information Last Verified		2008-12-28
NCI Grant/Contract Number		CA15704

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