Status:
COMPLETED
Bortezomib With Melphalan and Prednisone for Multiple Myeloma
Lead Sponsor:
Duke University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the efficacy of bortezomib in combination with melphalan and prednisone to achieve complete responses for patients with previously untreated multiple myeloma com...
Detailed Description
Based on the need to improve front-line therapy for patients less likely to undergo transplant, the promising recent in vitro and clinical work on melphalan and bortezomib, we propose a prospective tr...
Eligibility Criteria
Inclusion
- Patients must have histologically confirmed multiple myeloma, defined as at least one of the following major criteria and one minor criterion or at least three minor criteria:
- Major Criteria Minor Criteria Plasmacytoma on tissue biopsy Marrow plasmacytosis 10-29% Marrow plasmacytosis ≥ 30% Monoclonal protein present, less than major criteria Monoclonal protein: Lytic bone lesions
- Immunoglobulin G (IgG) \> 3.5 g/dl Decrease in uninvolved immunoglobulins:
- Immunoglobulin A (IgA) \> 2 g/dl Immunoglobulin M (IgM) \< 50 mg/dl Bence Jones ≥ 1 g/24 hr IgA \< 100 mg/dl IgG \< 600 mg/dl
- No prior therapy
- Life expectancy greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status \<3 (Karnofsky \>40%
- Patients must have normal organ and marrow function. Patients with severe pancytopenia due to myeloma involvement of the bone marrow and patients with renal insufficiency (creatinine \> 2 mg/dl) due to myeloma will also be included.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Pregnant women
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to bortezomib, melphalan, or other agents used in the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy. Therefore, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with bortezomib or other agents administered during the study.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00734149
Start Date
July 1 2004
End Date
February 1 2008
Last Update
November 7 2023
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710