A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma
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 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)
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Assessing Patient Response to Bendamustine - Phase I by assessing patient adverse events
Determine the maximum tolerated dose of bendamustine in association with bortezomib and pegylated liposomal doxorubicin in patients with relapsed or refractory Multiple Myeloma.
6 months
Yes
Sherif Farag, M.B., B.S.
Study Chair
Hoosier Oncology Group
United States: Institutional Review Board
MM08-141
NCT01177683
July 2010
December 2013
Name | Location |
---|---|
Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
IU Health Arnett Cancer Center | Lafayette, Indiana 47904 |
IU Health Central Indiana Cancer Centers | Indianapolis, Indiana 46219 |
Metro Health Cancer Care | Wyoming, Michigan 49519 |
IU Health Goshen Hospital | Goshen, Indiana 46527 |
Floyd Memorial Cancer Center of Indiana | New Albany, Indiana 47150 |
University Hospitals Seidman Cancer Center | Cleveland, Ohio 44106 |