Status:
COMPLETED
Bendamustine Hydrochloride, Bortezomib, and Dexamethasone in Treating Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Sidney Kimmel Cancer Center at Thomas Jefferson University
Conditions:
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies side effects and how well bendamustine hydrochloride, bortezomib, and dexamethasone work in treating patients with newly diagnosed multiple myeloma. Drugs used in chemother...
Detailed Description
PRIMARY OBJECTIVES: I. Establish the response rate of induction therapy following 4 cycles of the combination regimen bendamustine (bendamustine hydrochloride), bortezomib and dexamethasone (BBd) in ...
Eligibility Criteria
Inclusion
- New diagnosis of multiple myeloma with no prior history of systemic treatment (Exceptions include corticosteroids, bisphosphonates, single agent cyclophosphamide, \<= 21 days of the first cycle of a planned regimen
- \>= 18 years of age
- ECOG \<= 3
- Signed informed consent
- Measurable serum paraprotein on SPEP or serum free light chains and ratio, or quantifiable Bence-Jones proteinuria on 24 hour urine specimen. If the monoclonal protein has merged with the beta region we will follow the serum immunoglobulin of the involved heavy chain and comment on either partial remission (PR, as judged by two protocol investigators) or complete remission (CR, as defined by the achievement of PR as above and the resolution of the monoclonal protein by immunofixation in the serum and urine.)
Exclusion
- Failure to sign informed consent
- Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or plasma cell leukemia
- History of previously treated smoldering myeloma
- Grade 3 or above peripheral neuropathy
- Uncontrolled human immunodeficiency virus (HIV)
- Active hepatitis A, B or C
- Pregnant or lactating females
- Total bilirubin \>3 times the upper limit of normal
- ASLT/ALT \> 2.5 times the upper limit of normal
Key Trial Info
Start Date :
August 25 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2018
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02224729
Start Date
August 25 2014
End Date
November 17 2018
Last Update
April 30 2025
Active Locations (1)
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1
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107