Expired Study
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Indianapolis, Indiana 46219


Purpose:

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.


Study summary:

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)


Criteria:

Inclusion Criteria: - 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 Criteria: - 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.


NCT ID:

NCT01177683


Primary Contact:

Study Chair
Sherif Farag, M.B., B.S.
Hoosier Cancer Research Network


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 46219
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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