Overview

This trial is active, not recruiting.

Condition multiple myeloma
Treatments bendamustine, doxorubicin, bortezomib, filgrastim
Phase phase 1/phase 2
Target proteasome
Sponsor Sherif Farag, MB, BS
Collaborator Hoosier Cancer Research Network
Start date July 2010
End date December 2016
Trial size 69 participants
Trial identifier NCT01177683, MM08-141

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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

Primary Outcomes

Measure
Assessing Patient Response to Bendamustine - Phase I by assessing patient adverse events
time frame: 6 months
Overall Response Rate of Treatment Regimen - Phase II by assessing patient response rates
time frame: 8 months

Secondary Outcomes

Measure
Toxicity of Treatment Regimen - Phase I and II by assessing patient adverse events
time frame: 6 months
Evaluation of Survival - Phase II by assessing patient survival times
time frame: 8 months
Bendamustine Pharmacokinetics - Phase II by evaluating patient samples
time frame: 8 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
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 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)
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hoosier Cancer Research Network.
Location data was received from the National Cancer Institute and was last updated in August 2016.