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

RATIONALE: Biological therapies, such as thalidomide and clarithromycin, may stimulate the immune system in different ways and stop cancer cells from growing. Thalidomide and clarithromycin may also stop the growth of multiple myeloma by blocking blood flow to the cancer. 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 thalidomide together with dexamethasone and clarithromycin after an autologous or syngeneic bone marrow or stem cell transplant may be an effective treatment for multiple myeloma.

PURPOSE: This phase II trial is studying how well giving thalidomide together with dexamethasone and clarithromycin works in treating patients who have undergone a previous autologous or syngeneic bone marrow or stem cell transplant for multiple myeloma.

Study Type: Interventional

Study Design: Treatment, Open Label

Study Primary Completion Date: October 2018

OBJECTIVES: - Determine the toxicity of maintenance therapy comprising thalidomide, dexamethasone, and clarithromycin in patients with multiple myeloma who have undergone prior autologous or syngeneic bone marrow or peripheral blood stem cell transplantation. - Determine the median time to disease progression in patients treated with this regimen. - Determine overall survival and disease-free survival of patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide once daily, oral dexamethasone once weekly, and oral clarithromycin twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. After completion of 1 year of treatment, patients discontinue oral clarithromycin, receive tapering doses of oral dexamethasone once weekly for 8 weeks, and continue to receive oral thalidomide once daily in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2-3 years.

Intervention(s) in this Clinical Trial

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

Primary Measures

• Toxicity
  • Safety Issue?: Yes
• Median time to disease progression
  • Safety Issue?: No
• Survival
  • Safety Issue?: No

DISEASE CHARACTERISTICS:

• Diagnosis of multiple myeloma
• Any stage disease
• Has undergone prior high-dose (i.e., ≥ 140 mg/m^2) melphalan therapy and autologous or syngeneic bone marrow or peripheral blood stem cell transplantation within the past 30-120 days

PATIENT CHARACTERISTICS:

• Age
• Not specified
• Performance status
• Karnofsky 70-100%
• Life expectancy
• Not specified
• Hematopoietic
• Platelet count > 50,000/mm^3 (transfusion independent)
• Absolute granulocyte count > 1,500/mm^3 (for 5 calendar days after recovery from high-dose melphalan therapy)
• Hepatic
• SGOT or SGPT ≤ 2.5 times upper limit of normal
• Bilirubin ≤ 2 mg/mL (unless due to Gilbert's disease)
• Renal
• Not specified
• Cardiovascular
• No history of myocardial infarction
• No history of deep vein thrombosis
• No history of arterial occlusions
• LVEF ≥ 45%
• No congestive heart disease
• No coronary artery disease
• Pulmonary
• No history of pulmonary emboli
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile female patients must use effective contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after the completion of study treatment (during and for 4 weeks after the completion of study treatment for male patients)
• No blood, ova, or sperm donation during study treatment
• No history of seizures
• No allergy to any study drugs
• No untreated systemic infection

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• See Disease Characteristics
• Recovered from prior autologous or syngeneic bone marrow or peripheral blood stem cell transplantation
• Combination therapy with thalidomide, clarithromycin, and steroids prior to transplantation allowed provided disease responded to the combination therapy
• Chemotherapy
• See Disease Characteristics
• Endocrine therapy
• See Biologic therapy
• Radiotherapy
• Not specified
• Surgery
• Not specified
• Other
• No prior or concurrent participation on another transplant clinical trial that has evaluated (or is evaluating) disease-free survival or overall survival
• No other concurrent anticancer therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

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 December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00182663

Study ID Number: CDR0000439530

ClinicalTrials.gov Identifier: NCT00182663

Health Authority: United States: Federal Government

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