Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment w/ Carfilzomib, Lenalidomide (Revlimid®) and Dexamethasone (CRD) in Subjects w/ Newly Diagnosed, Previously Untreated Multiple Myeloma Requiring Systemic Chemotherapy
During the Phase I portion of this clinical trial, the dose of Revlimid® and carfilzomib
will be increased until the best and safest amount (or dose) is identified in combination
with standard doses of Revlimid® and dexamethasone. "Investigational" means that the drug
combination is still being studied and that research doctors are trying to find out more
about it such as the safest dose to use, the side effects it may cause and how effective the
Revlimid® and carfilzomib and dexamethasone investigational combination is for treating
newly diagnosed multiple myeloma. In this clinical trial we are looking for the highest dose
of the combination that can be given safely and see how well it works as a combination in
newly diagnosed patients.
The drug, carfilzomib, has not yet been approved by the FDA (U.S. Food and Drug
Administration). Revlimid® and Dexamethasone have been approved by the FDA. The drugs have
not been approved in this combination for use for your type of cancer or any other type of
cancer. Carfilzomib is being researched to treat multiple myeloma. Dexamethasone is commonly
used, either alone, or in combination with other drugs, to treat multiple myeloma. Revlimid®
is currently approved by the US FDA in combination with dexamethasone for the treatment of
patients with multiple myeloma who have received at least 1 prior therapy.
After the Phase I clinical trial defines the safest doses of Revlimid® and carfilzomib and
dexamethasone that can be taken together, the research study will move on to its second
portion, a Phase II clinical trial. The Phase II portion of the clinical trial will test the
clinical effectiveness of the best dose combination of the three drugs.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
• Phase 1b - Safety and MTD of the combination therapy • Phase 2 - Week 16 (end of cycle 4) complete and near complete response rate (sCR, CR, CR)
Mark Kaminski, M.D.
University of Michigan Cancer Center
United States: Food and Drug Administration
|University of Michigan Comprehensive Cancer Center||Ann Arbor, Michigan 48109-0752|
|Washington University School of Medicine||Saint Louis, Missouri 63110|
|Hackensack University Medical Center||Hackensack, New Jersey 07601|
|Mt. Sinai Medical Center||New York, New York 10029|