Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT02224729|
Recruitment Status : Completed
First Posted : August 25, 2014
Results First Posted : June 7, 2018
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma||Drug: Bendamustine hydrochloride Drug: Bortezomib Drug: Dexamethasone||Phase 2|
I. Establish the response rate of induction therapy following 4 cycles of the combination regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in patients with newly diagnosed multiple myeloma.
II. Describe the tolerability and toxicities of this regimen. III. Provide one-year progression-free survival and one-year overall survival data following this therapeutic strategy.
Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2; bortezomib subcutaneously (SC) on days 1, 8, 15, and 22; and dexamethasone orally (PO) on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a very good partial response (VGPR) or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.
NOTE: Patients requiring immediate reduction in paraprotein during course 1 only receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib IV on days 1, 4, 8, and 11; and dexamethasone PO on days 1-4.
After completion of study treatment, patients are followed up for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Bendamustine, Bortezomib, and Dexamethasone (BBD) for Newly Diagnosed Patients With Multiple Myeloma|
|Actual Study Start Date :||August 25, 2014|
|Actual Primary Completion Date :||April 21, 2016|
|Actual Study Completion Date :||November 17, 2018|
Experimental: Bendamustine, Bortezomib, Dexamethasone (Standard)
Patients receive bendamustine hydrochloride IV over 30 minutes on days 1 and 2; bortezomib SC on days 1, 8, 15, and 22; and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 35 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than a VGPR or with more than 10% bone marrow plasmacytosis may receive 2 additional courses.
Drug: Bendamustine hydrochloride
- Count of Participants That Experience Overall Response Following 4 Cycles of the Combination Regimen BBd [ Time Frame: At least 140 days ]ORR (partial remission or better) to induction therapy following 4 cycles of the combination regimen BBd.
- Incidence of Grade 3-4 Adverse Events From the Combination of Bendamustine Hydrochloride, Bortezomib, and Dexamethasone Based on the Common Terminology Criteria Version 4.0 [ Time Frame: Up to 1 year ]All adverse events are tracked during the course of the trial. Adverse events with a grade of 3-4 will be tracked and recorded.
- Count of Participants That Experience Very Good Partial Remission (VGPR) [ Time Frame: Up to 1 year ]Very good partial remission (VGPR) to induction therapy following 4 cycles of the combination regimen BBd. As defined as no dectable M-protein on SPEP (Serum protein electrophoresis) but positive IFX (Immunofixation) on serum or urine and >90% reduction of M-protein in serum and urine
- Count of Participants That Experience Progression-free Survival (PFS) [ Time Frame: 1 year ]The amount of participants that survive one year after treatment with BBd and do not experience worsening disease.
- Count of Participants That Experience Overall Survival (OS) [ Time Frame: 1 year ]The amount of participants that start treatment with BBd and survive at least one year post treatment completion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02224729
|United States, Pennsylvania|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Joanne Filicko-O'Hara, MD||Sidney Kimmel Cancer Center at Thomas Jefferson University|