Status:
TERMINATED
Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to determine the safety and efficacy of the use of bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myelo...
Detailed Description
Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the second most commo...
Eligibility Criteria
Inclusion
- Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy
- Must have adequate liver and renal function
- Zubrod Performance Status (ZPS) of 2 or better
- Must have measurable disease
Exclusion
- Peripheral neuropathy of grade II or higher
- Thrombocytopenia (platelets less than 50,000/uL)
- Neutropenia (ANC\<1000/uL)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.4 X ULN
- Total bilirubin \>1.5 X upper limit of normal (ULN)
- Creatinine clearance of less than 45 milliliters per minute (mL/min)
- Patients with HIV
- Patients with active hepatitis
- Pregnant or lactating women
- Individuals of child-bearing potential not using adequate contraception
- Individuals unable to provide informed consent
Key Trial Info
Start Date :
May 5 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 18 2014
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT01484626
Start Date
May 5 2011
End Date
June 18 2014
Last Update
July 10 2018
Active Locations (1)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153