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

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 clinical trial studies lenalidomide, dexamethasone, and clarithromycin in treating patients who have undergone stem cell transplant for multiple myeloma

OBJECTIVES:

I. Evaluate the toxicity of the use of Lenalidomide/Biaxin/Dexamethasone as maintenance therapy after autologous/syngeneic transplant.

II. Evaluate the median time to disease progression. III. Evaluate survival.

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

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

After completion of study treatment, patients are followed up periodically.

Intervention(s) in this Clinical Trial

• Drug: lenalidomide
  • Given orally
• Drug: dexamethasone
  • Given orally
• Drug: clarithromycin
  • Given orally

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm I
  • Patients receive oral clarithromycin twice daily and oral dexamethasone once a week. Treatment with clarithromycin and dexamethasone continues for up to 1 year* in the absence of disease progression or unacceptable toxicity. Patients also receive oral lenalidomide once daily on days 1-14. Courses with lenalidomide repeat every 21 days in the absence of disease progression or unacceptable toxicity. NOTE: *After one year of treatment, dexamethasone is tapered for an additional 4 weeks.

Primary Measures

• Toxicity of this proposed treatment with clarithromycin (Biaxin), dexamethasone, and lenalidomide
  • Time Frame: The first 3 months of therapy
    Safety Issue?: Yes
• Time to disease progression
  • Time Frame: Every 2 weeks for the first 3 months and then monthly or every 3 months during treatment
    Safety Issue?: No

Inclusion Criteria:

• Any autologous or syngeneic patient who underwent high dose melphalan (>= 140 mg/m^2) therapy/PBSC or BM rescue for any stage of multiple myeloma and did not participate in another clinical transplant trial which is also evaluating long-term disease free survival or survival
• Platelet count (transfusion independent) > 50,000 cells/mm^3 and absolute granulocyte count > 1500 cells/mm^3 for 5 calendar days after recovery from high dose therapy
• Patients should be between 30 days to 120 days after transplant
• Willingness and ability to comply with FDA-mandated REV ASSIST Program, Celgene
• System for Lenalidomide Education and Prescribing Safety
• Signing a written informed consent form

Exclusion Criteria:

• Karnofsky score less than 70
• A left ventricular ejection fraction less than 45% immediately pre transplant;
• patients with congestive heart disease with transplant, history of MI, or history of coronary artery disease
• Total bilirubin greater than 2 mg/ml (unless history of Gilbert's disease), SGOT or SGPT > 2.5 x upper limit of normal
• Calculated by Cockcroft-Gault formula or measured serum creatinine clearance < 25 ml/minute
• Pregnant and/or lactating females
• Patients who cannot give informed consent
• Patients with untreated systemic infection
• Patients with history prior to transplant of treatment with combination therapy
• Lenalidomide/Biaxin and Steroid without response
• Patients allergic to Lenalidomide, Biaxin or Dexamethasone
• Referring physician not registered with REV ASSIST program or unwilling to oversee the care of the patients on study and comply with the FDA-mandated REV ASSIST Program
• Patients unwilling to practice adequate forms of contraception if clinically indicated until 30 days after stopping therapy; male patients on study need to be consulted to use latex condoms (even if they have had a vasectomy) every time they have sex with a woman who is able to have children while they are being treated and for 30 days after stopping drugs
• Patients with >= grade 3 peripheral neuropathy
• Prior history of uncontrollable side effects to Dexamethasone therapy
• A prior history of HIV positivity with pre-transplant evaluation

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 Investigator: Fred Hutchinson Cancer Research Center Other

Overall Clinical Trial Officials and Contacts

Leona Holmberg Principal Investigator Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium  

Information obtained from ClinicalTrials.gov on February 09, 2012

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

Study ID Number: 2135.00

ClinicalTrials.gov Identifier: NCT00445692

Health Authority: United States: Food and Drug Administration