An Open-Label Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participants With Dose Limiting Toxicity (DLT)
Maximum tolerated dose was the dose that was 1 step lower than the dose where at least one third of patients experienced DLT. A DLT was defined as any of the following occurring during the first cycle: grade 4 hematologic toxicity without regard for relationship to study drug treatment thrombocytopenia grade 3 with grade 3 or grade 4 hemorrhage grade 3 febrile neutropenia grade 3 or grade 4 nausea and vomiting refractory to anti emetic therapy any study drug related grade 3 or grade 4 nonhematologic toxicity any drug related death Toxicity grades (3=severe AE and 4=life-threatening or disabling AE) were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.
Day 1 - 28
Yes
Sponsor's Medical Expert
Study Director
Cephalon
United States: Food and Drug Administration
C18083/1063/MM/US
NCT00920855
June 2009
December 2011
Name | Location |
---|---|
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
University of California, San Diego | La Jolla, California 92037-1709 |
George Washington University | Washington, District of Columbia 20037 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Charleston Hematology Oncology, PA | Charleston, South Carolina 29403 |
Family Cancer Center, PLLC | Collierville, Tennessee 38017 |
NorthShore University health system | Evanston, Illinois 60201 |
Pacific Oncololgy & Hematology | Encinitas, California |
Capitol Hematology Oncology | Roseville, California |
James R. Berenson, M.D., Inc. | West Hollywood, California |
Alivin & Lois Lapidus Cancer Institute | Baltimore, Maryland |
Sophia Gordon Cancer Center at Lahey Clinic | Burlington, Massachusetts |
Fairfax Northern Virginia Hematology Oncology | Fairfax, Virginia |