Official Title: “Maintenance Therapy With Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma”

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.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: January 2018

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 30 patients will be accrued for this study.

Intervention(s) in this Clinical Trial

• Drug: clarithromycin
• Drug: dexamethasone
• Drug: lenalidomide
• Procedure: adjuvant therapy

Primary Measures

• Toxicity
  • Safety Issue?: Yes
• Time to disease progression
  • Safety Issue?: No
• Overall survival
  • Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Fred Hutchinson Cancer Research Center

Overall Clinical Trial Officials and Contacts

Leona A. Holmberg, MD, PhD Principal Investigator Fred Hutchinson Cancer Research Center  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00445692

Study ID Number: CDR0000533873

ClinicalTrials.gov Identifier: NCT00445692

Health Authority: Unspecified

Clinical trial summary from the National Cancer Institute's PDQ® database