Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Trial of Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin in Patients With Relapsed or Refractory Multiple Myeloma: Hoosier Cancer Research Network MM08-141
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.
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) ;
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