Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma
|Multiple Myeloma||Drug: dexamethasone Drug: clarithromycin Drug: Pomalidomide||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Dexamethasone (DECADRON®), Clarithromycin (BIAXIN®), and Pomalidomide (CC-4047®) for Subjects With Relapsed or Refractory Multiple Myeloma|
- Overall Response Rate [ Time Frame: from baseline to cycle with maximum response, which was achieved on average after 2 cycles ]Best response rate was recorded for all patients, using the IMWG criteria.
- 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 ]
|Actual Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2020|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: all patients
Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be 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. Dosing will be in the morning at approximately the same time each day.
40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
Other Name: DecadronDrug: clarithromycin
orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
Other Name: BiaxinDrug: Pomalidomide
orally 4mg daily for days 1-21 of each 28 day cycle
Other Name: CC-4047
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159574
|United States, New York|
|Weill Cornell Medical College|
|New York, New York, United States, 10065|
|Principal Investigator:||Ruben Niesvizky, MD||Weill Medical College of Cornell University|