Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
NCT ID: NCT01177683
Last Updated: 2023-10-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2010-07-31
2017-12-31
Brief Summary
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Detailed Description
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Phase II 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 at MTD IV over 1 hour, Days 1 and 4 Filgrastim (if defined in MTD) 5 µg/kg/day SC, Starting day 6 until neutrophil recovery to ANC \>1000
1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles.
ECOG Performance Status: 0-2
Hematopoietic:
* Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3
* Platelets ≥ 75 x K/mm3
Hepatic:
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST ≤ 2.5 x ULN
* ALT ≤ 2.5 x ULN
Renal:
* Serum creatinine \< 3.0 mg/dL
Cardiovascular:
* LVEF \>45% corrected by MUGA scan or echocardiogram.
* No unstable angina pectoris or recent myocardial infarction (within 6 months)
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm 1
Bendamustine in combination with bortezomib and pegylated liposomal doxorubicin.
Bendamustine
Phase I component:
Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4
Doxorubicin
Phase I and II components:
Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4
Bortezomib
Phase I and II components:
Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11
Bendamustine
Phase II component:
Bendamustine at at MTD IV over 1 hour, Days 1 and 4
Filgrastim
Phase II component:
Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000
Interventions
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Bendamustine
Phase I component:
Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4
Doxorubicin
Phase I and II components:
Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4
Bortezomib
Phase I and II components:
Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11
Bendamustine
Phase II component:
Bendamustine at at MTD IV over 1 hour, Days 1 and 4
Filgrastim
Phase II component:
Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC \>1000
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Hoosier Cancer Research Network
OTHER
Cephalon, Inc.
INDUSTRY
Sherif Farag, MB, BS
OTHER
Responsible Party
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Sherif Farag, MB, BS
Sponsor-Investigator
Principal Investigators
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Sherif Farag, M.B., B.S.
Role: STUDY_CHAIR
Hoosier Cancer Research Network
Locations
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Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Community Regional Cancer Center
Indianapolis, Indiana, United States
IU Health Arnett Cancer Center
Lafayette, Indiana, United States
Metro Health Cancer Care
Wyoming, Michigan, United States
University of Rochester Medical Center
Rochester, New York, United States
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Hoosier Oncology Group Homepage
Other Identifiers
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MM08-141
Identifier Type: -
Identifier Source: org_study_id
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