Phase 2
Completed N=45
Bortezomib With Melphalan and Prednisone for Multiple Myeloma
Source: ClinicalTrials.gov NCT00734149 ↗Enrolled (actual)
45
Serious AEs
13.3%
Results posted
May 2013
Primary outcomePrimary: Response — 42 participants
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 compared to an historical control group. This trial will also evaluate the safety and toxicity of this regimen as well as evaluate the duration of response of this regimen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response |
42 | — |
| SECONDARY Number of Patients With Any Grade or Severe Adverse Event |
34 | — |
| SECONDARY Median Duration of Response |
19.8; 27.9 | — |
Eligibility Criteria
Inclusion Criteria
- 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) 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00734149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.