In this study, investigators will evaluate the activity of bendamustine, bortezomib and dexamethasone (BBD). This regimen combines 3 agents with high activity in multiple myeloma, with different mechanisms of action and non-overlapping toxicities.
The purpose of this study is to assess the efficacy, tolerability, and toxicity of bendamustine, bortezomib, and dexamethasone (BBD) as first-line treatment of multiple myeloma (MM) patients who are transplant ineligible or who are not candidates for high dose chemotherapy. Eligible patients will receive protocol treatment for up to 34 weeks plus the screening period (up to 2 weeks). Response assessments will occur every 4 weeks and confirmed using the International Myeloma Working Group Uniform Response Criteria. Patients having an objective response or stable disease will continue to maintenance therapy until disease progression or intolerable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
59
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.
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
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
Los Robles Hospital and Medical Center
Thousand Oaks, California, United States
Florida Cancer Specialists
Fort Myers, Florida, United States
Hematology Oncology Clinic, LLP
Baton Rouge, Louisiana, United States
Complete Response Rate
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.
Time frame: every 8 weeks for approximately 48 months
Number of Patients Who Experienced Serious and Non-serious Adverse Events
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.
Time frame: approximately 36 weeks
Progression Free Survival
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.
Time frame: every 8 weeks for up to 48 months
Overall Survival
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.
Time frame: every 4 weeks until progressive disease then every 12 weeks, projected 48 months
Overall Response Rate
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States
Oncology Hematology Care Inc.
Cincinnati, Ohio, United States
South Carolina Oncology Associates
Columbia, South Carolina, United States
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
...and 3 more locations
Time frame: every 4 weeks for approximately 2 years