Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma
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.
Multiple Myeloma and Plasma Cell Neoplasm
Drug: Arsenic trioxide
Biological: Autologous hematopoietic stem cell transplantation
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Clinical Trial of Dose Escalated Bortezomib + ATO (Arsenic Trioxide) + Melphalan as a Conditioning Regimen for Multiple Myeloma|
- Evaluate toxicity of the conditioning treatment regimen. [ Time Frame: 3 ¼ years ] [ Designated as safety issue: Yes ]
- Evaluate response and overall survival (OS). [ Time Frame: 3 ¼ years ] [ Designated as safety issue: No ]
- Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy [ Time Frame: 3 ¼ years ] [ Designated as safety issue: No ]
|Study Start Date:||June 2007|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Drug: Arsenic trioxide
- L-phenylalanine mustard
- Evaluate toxicity of a conditioning treatment regimen comprising bortezomib, arsenic trioxide, and melphalan.
- 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.
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center - Miami|
|Miami, Florida, United States, 33136|
|Study Chair:||Mark S. Goodman, MD||University of Miami Sylvester Comprehensive Cancer Center|