Bendamustine, Wkly Bortezomib, Lenalidomide and Dexamethasone for Multiple Myeloma
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Bendamustine, Bortezomib, Lenalidomide, Dexamethasone, Treanda, Velcade, Revlimid
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: Bortezomib Type: Drug
Name: Lenalidomide Type: Drug
Name: Dexamethasone Type: Drug
Overall Status
Recruiting
Summary
The purpose of the study is to determine the safety and efficacy of the use of Bendamustine in combination with a commonly used combination chemotherapy to treat relapsed and refractory multiple myeloma. The study will be conducted in two phases. Participants in phase I will receive 1 of 4 escalating doses of bendamustine. Once the maximum tolerated dose of bendamustine is determined phase II of this trial will begin. Participants in phase II will receive the maximum tolerated dose of bendamustine in combination with standard of care chemotherapy.
Detailed Description
Multiple myeloma is a multi-organ neoplastic disorder caused by the clonal proliferation of plasma cells. It has an incidence of about 4.5/100,000 per year in the U.S., making it the second most common hematologic malignancy. For many years, alkylating agents have been the backbone of treatment. The combination of melphalan and prednisone was, for many years, the standard of care for patients who were not candidates for autologous transplantation. Melphalan continues to be the primary conditioning agent for autologous transplant,and cyclophosphamide has also gained a foothold in the treatment of this disease.

The introduction of novel agents has fundamentally changed the landscape of treating this disease, although the true effects on survival are not yet known. Immunomodulatory agents and proteosome inhibitors, including thalidomide, lenalidomide and bortezomib, have been used in both newly diagnosed and relapsed patients. Currently, there is intense clinical research on the optimal way to combine these novel agents with the traditional backbones of treatment - including alkylators, with one another and, eventually, with the subsequent iterations of these classes of drugs. However, despite the therapeutic excitement surrounding this disease, nearly all patients will relapse, and cure remains an elusive goal for all but a rare handful.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Adults with relapsed and/or refractory myeloma who have received between 1-4 prior lines of therapy

- must have adequate liver and renal function

- ZPS of 2 or better

- must have measurable disease

Exclusion Criteria:

- Peripheral neuropathy of grade II or higher

- Thrombocytopenia (platelets less than 50,000/uL)

- Neutropenia (ANC<1000/uL)

- AST or ALT >2.4 X ULN

- Total bilirubin >1.5 X ULN

- Creatinine clearance of less than 60mL/min (Phase I) and of 40mL/min or less (Phase II)

- Patients with HIV

- Patients with active hepatitis

- Pregnant or lactating women

- Individuals of child-bearing potential not using adequate contraception

- Individuals unable to provide informed consent
Location
Loyola Univ Med Cntr - Cardinal Bernardin Cancer Center
Maywood, Illinois, United States
Status: Recruiting
Contact: Laura Michaelis, MD - 708-327-3216 - lmichaelis@lumc.edu
Start Date
May 2011
Completion Date
May 2015
Sponsors
Loyola University
Source
Loyola University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page