Status:
COMPLETED
Study of Bendamustine Combined With Bortezomib for Patients With Relapsed/Refractory Multiple Myeloma
Lead Sponsor:
Cephalon
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to assess the safety and tolerability of bendamustine as combination therapy with bortezomib for patients with relapsed/refractory multiple myeloma (MM).
Eligibility Criteria
Inclusion
- The patient:
- has a diagnosis of multiple myeloma.
- currently has multiple myeloma with measurable disease.
- must have received at least 1 previous treatment regimen and shows signs of progressive disease at the time of study entry.
- if a woman of child bearing potential (not surgically sterile or at least 12 months naturally postmenopausal), must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study.
- if a man, must agree to use an acceptable method of contraception throughout the study and for 90 days after last dose study drug.
- must have an Eastern Cooperative Oncology Group (ECOG) performance status not greater than 2.
- must have a life-expectancy of greater than 3 months.
- must meet specific protocol-related hematological and laboratory criteria within 14 days of enrollment.
Exclusion
- The patient has:
- had a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix).
- plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes (POEMS) syndrome.
- plasma cell leukemia.
- non-measurable multiple myeloma.
- Common Terminology Criteria for Adverse Events (CTCAE) grade 2 (or greater) peripheral neuropathy within 14 days before enrollment.
- previously participated in a Cephalon-sponsored clinical study with bendamustine.
- impaired cardiac function or clinically significant cardiac diseases.
- undergone major surgery within 4 weeks prior to screening or has not recovered from side effects of such therapy.
- severe hypercalcemia.
- other concurrent severe and/or uncontrolled medical or psychiatric conditions.
- known positivity for human immunodeficiency virus (HIV) or hepatitis B or C.
- a history of allergic reaction attributable to compounds of similar chemical or biological composition to bendamustine, bortezomib, boron, or mannitol.
- received chemotherapy within 3 weeks before enrollment, with the exception of nitrosoureas, which should be discontinued at least 6 weeks before enrollment.
- received corticosteroids (greater than 10 mg/day prednisone or equivalent) within 3 weeks before enrollment.
- received immunotherapy, antibody, or radiation therapy within 4 weeks before enrollment.
- a status as a pregnant or lactating woman. Any women becoming pregnant during the study will be withdrawn from the study.
- a status as a male whose sexual partner is a woman of childbearing potential not using effective birth control.
- used an investigational drug within 1 month before the screening visit.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00920855
Start Date
June 1 2009
End Date
December 1 2011
Last Update
October 4 2012
Active Locations (13)
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1
Pacific Oncololgy & Hematology
Encinitas, California, United States
2
Capitol Hematology Oncology
Roseville, California, United States
3
University Of California, San Diego
San Diego, California, United States
4
James R. Berenson, M.D., Inc.
West Hollywood, California, United States