Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bendamustine Type: Drug
Name: Doxorubicin Type: Drug
Name: Bortezomib Type: Drug
Name: Bendamustine Type: Drug
Name: Filgrastim Type: Drug
Overall Status
Recruiting
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.
Detailed 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)
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
Cancer Care Center of Southern Indiana
Bloomington, Indiana, United States
Status: Withdrawn
IU Health Goshen Hospital
Goshen, Indiana, United States
Status: Withdrawn
Community Regional Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Anuj Agarwala, M.D. - 317-621-7104
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Sherif Farag, M.B., B.S. - 317-274-0843 - ssfarag@iupui.edu
IU Health Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Status: Recruiting
Contact: Hillary Wu, M.D. - 317-964-5253 - hwu@iuhealth.org
IU Health Arnett Cancer Center
Lafayette, Indiana, United States
Status: Recruiting
Contact: Bamidele Adesunloye, M.D. - 765-448-7500
Floyd Memorial Cancer Center of Indiana
New Albany, Indiana, United States
Status: Withdrawn
Metro Health Cancer Care
Wyoming, Michigan, United States
Status: Terminated
University Hospitals Seidman Cancer Center
Cleveland, Ohio, United States
Status: Terminated
Start Date
July 2010
Completion Date
July 2017
Sponsors
Sherif Farag, MB, BS
Source
Hoosier Cancer Research Network
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page