Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy
|ClinicalTrials.gov Identifier: NCT01056276|
Recruitment Status : Completed
First Posted : January 26, 2010
Results First Posted : March 28, 2017
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: Bendamustine Drug: Bortezomib Drug: Dexamethasone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study for the Evaluation of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy|
|Study Start Date :||May 2010|
|Primary Completion Date :||August 2015|
|Study Completion Date :||February 2017|
Bendamustine, Bortezomib,and Dexamethasone for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by IMWG criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone until disease progression or intolerable toxicity.
Treatment: 80 mg/m2 via intravenous (IV) Days 1 and 2; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
Other Name: TreandaDrug: Bortezomib
1.3 mg/m2 IV Days 1, 8, 15; repeat cycles every 28-days for 8 cycles or 2 cycles beyond confirmed complete response.
Maintenance: 1.3 mg/m2 IV or SQ Days 1, 15
Other Name: VelcadeDrug: Dexamethasone
20 mg orally (PO) Days 1, 2, 8, 9, 15, 16 every 28-days for 8 cycles or 2 cycles beyond confirmed complete response, Maintenance: 20 mg PO Days 1, 15
- Complete Response Rate [ Time Frame: every 8 weeks for approximately 48 months ]Defined as the percent of patients having a complete response (CR) to treatment, assessed using the International Myeloma Working Group (IMWG) Uniform Response Criteria. CR=disappearance of soft tissue plasmacytomas and 5% or less plasma cells in bone marrow.
- Number of Patients Who Experienced Serious and Non-serious Adverse Events [ Time Frame: approximately 36 weeks ]All serious adverse events (SAEs) and non-serious adverse events (AEs) were assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0, and were collected from start of study treatment until 30 days after last dose of study medication. Refer to the Adverse Event module for specific terms.
- Progression Free Survival [ Time Frame: every 8 weeks for up to 48 months ]Defined as the interval of time (in months) that patient are alive from date of first protocol treatment to date of documented tumor progression or date of death from any cause. Progressive disease, assessed according to International Myeloma Working Group Uniform Response Criteria, is defined as at least a 25% increase from the nadir in any one of the following criteria: serum M-protein, urine M-protein, or bone marrow plasma cell percentage of 10% or greater.
- Overall Survival [ Time Frame: every 4 weeks until progressive disease then every 12 weeks, projected 48 months ]Defined as the interval of time, in months, from first study treatment until the earlier of the date of death or date last known alive.
- Overall Response Rate [ Time Frame: every 4 weeks for approximately 2 years ]The number of patients with observed complete or partial response (CR or PR) assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. PR=50% or greater reduction from baseline in serum M-protein and 90% or greater reduction from baseline in 24-hour urinary M-protein.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01056276
|United States, California|
|Los Robles Hospital and Medical Center|
|Thousand Oaks, California, United States, 91360|
|United States, Florida|
|Florida Cancer Specialists|
|Ft. Myers, Florida, United States, 33916|
|United States, Louisiana|
|Hematology Oncology Clinic, LLP|
|Baton Rouge, Louisiana, United States, 70809|
|United States, Maryland|
|Center for Cancer and Blood Disorders|
|Bethesda, Maryland, United States, 20817|
|National Capital Clinical Research Consortium|
|Bethesda, Maryland, United States, 20817|
|United States, Michigan|
|Grand Rapids Clinical Oncology Program|
|Grand Rapids, Michigan, United States, 49503|
|United States, Ohio|
|Oncology Hematology Care Inc.|
|Cincinnati, Ohio, United States, 45242|
|United States, South Carolina|
|South Carolina Oncology Associates|
|Columbia, South Carolina, United States, 29210|
|United States, Tennessee|
|Chattanooga Oncology Hematology Associates|
|Chattanooga, Tennessee, United States, 37404|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|Leading Edge Research, PA|
|Arlington, Texas, United States, 75213|
|The Center for Cancer and Blood Disorders|
|Fort Worth, Texas, United States, 76104|
|United States, Virginia|
|Peninsula Cancer Institute|
|Newport News, Virginia, United States, 23601|
|Study Chair:||Jesus Berdeja, M.D.||SCRI Development Innovations, LLC|