Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma
- Conditions
- Multiple Myeloma and Plasma Cell Neoplasm
- Registration Number
- NCT00504101
- Lead Sponsor
- University of Miami
- Brief Summary
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as arsenic trioxide and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving high-dose combination chemotherapy together with bortezomib may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of bortezomib when given together with arsenic trioxide and melphalan in treating patients undergoing an autologous stem cell transplant for multiple myeloma.
- Detailed Description
OBJECTIVES:
Primary
* Evaluate toxicity of a conditioning treatment regimen comprising bortezomib, arsenic trioxide, and melphalan.
Secondary
* Evaluate response and overall survival.
* Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy (e.g., serum arsenic trioxide intracellular glutathione depletion, gene profiling of myeloma cells).
OUTLINE: This is a dose-escalation study of bortezomib.
* Conditioning regimen: Bortezomib will be given on days -6, -4, and -2, arsenic trioxide will be given on days -6, -5, -4, -3, and -2 (total of 5 doses), and melphalan will be given on day -2.
* Stem cell infusion: On day 0 a minimum of autologous 2 x 10\^6 CD34 cells/kg will be infused by central catheter.
After completion of study therapy, patients are followed periodically for at least 5 years.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Evaluate toxicity of the conditioning treatment regimen. 3 ¼ years
- Secondary Outcome Measures
Name Time Method Evaluate response and overall survival (OS). 3 ¼ years Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy 3 ¼ years
Trial Locations
- Locations (1)
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States