Study of Decadron, Biaxin, and Pomalidomide in Relapsed/Refractory Myeloma
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
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 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.
|Contact: Ruben Niesvizky, MDemail@example.com|
|United States, New York|
|Weill Cornell Medical College||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ruben Niesvizky, MD 646-962-2070 firstname.lastname@example.org|
|Principal Investigator: Ruben Niesvizky, MD|
|Principal Investigator:||Ruben Niesvizky, MD||Weill Medical College of Cornell University|