Status:
TERMINATED
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
Lead Sponsor:
Sherif Farag, MB, BS
Collaborating Sponsors:
Hoosier Cancer Research Network
Cephalon, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.
Detailed Description
Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle = 28 days Phase I...
Eligibility Criteria
Inclusion
- A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
- Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level \>100 mg/l for the involved free light chain.
- Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
- Must be willing to provide correlative blood samples.
Exclusion
- Must not have received an excessive cumulative dose of anthracycline
- No ≥ grade 2 peripheral neuropathy.
- No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
- No autologous stem cell transplant within 6 months prior to registration for protocol therapy
- No prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation.
- No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
- No known central nervous system involvement by myeloma.
- No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
- No patients known to be positive for HIV, or active Hepatitis A, B, or C.
- No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01177683
Start Date
July 1 2010
End Date
December 1 2017
Last Update
October 6 2023
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
2
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46219
3
Community Regional Cancer Center
Indianapolis, Indiana, United States, 46256
4
IU Health Arnett Cancer Center
Lafayette, Indiana, United States, 47904