This study is intended to investigate the combination of the combination of dexamethasone (Decadron®), Clarithromycin (Biaxin®), and pomalidomide (CC-4047®) \[ClaPd\] in multiple myeloma patients who have relapsed or refractory disease who have failed prior treatment with lenalidomide when used alone or in combination with corticosteroids. Primary endpoint will be response rate to treatment. Secondary endpoints will include toxicity of the combination, time to maximum response, and time to disease progression
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with lenalidomide. Up to 54 patients will be enrolled. Patients who sign informed consent form and fulfill all eligibility criteria will be enrolled. ClaPd therapy: Dexamethasone (40mg ) on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle. Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Serial clinic visits and laboratory measurements will be performed to monitor for treatment response. Those patients who demonstrate progression of disease at any point during ClaPd therapy will be taken off study. At the end of every cycle (which may coincide with day 1 of the new cycle), response and toxicity will be evaluated. During cycle 1, patients will have labwork done weekly (CBC with differential and blood electrolytes). All patients will remain on study until disease progression or side effects become excessive. Patients who achieve a stable plateau may be taken off study if eligible to proceed to high dose chemotherapy and autologous stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
121
40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
orally 4mg daily for days 1-21 of each 28 day cycle
Weill Cornell Medical College
New York, New York, United States
Overall Response Rate
Best response rate was recorded for all patients, using the IMWG criteria.
Time frame: from baseline to cycle with maximum response, which was achieved on average after 2 cycles
Time to Maximum Response, Expressed as Number of Cycles of Treatment to Maximum Response
Time frame: From baseline to cycle of maximum response, which occurred on average after 2 cycles; 1 cycle = 28 days
Time to Disease Progression (Progression Free Survival)
Time frame: From start of treatment, to date of disease progression
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