Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00504101|
Recruitment Status : Withdrawn (Temporarily closed to accrual pending availablity of drug.)
First Posted : July 19, 2007
Last Update Posted : December 15, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: Arsenic trioxide Drug: Bortezomib Drug: Melphalan Biological: Autologous hematopoietic stem cell transplantation||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Clinical Trial of Dose Escalated Bortezomib + ATO (Arsenic Trioxide) + Melphalan as a Conditioning Regimen for Multiple Myeloma|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
- Drug: Arsenic trioxide
Arsenic Trioxide will be given on day -6, -5, -4,-3,-2 (total of 5 doses). The dose of Arsenic trioxide (ATO) is 0.25 mg/m2.Other Name: ATO (As2O3)
- Drug: Bortezomib
Bortezomib will be given on day -6, -4, -2 (total 3 doses) beginning at a dose of 0.8 mg/m2 each day of therapy.Other Names:
- Drug: Melphalan
Melphalan will be given at 200 mg/m2 on day -2 (1 dose only)Other Names:
- L-phenylalanine mustard
- Biological: Autologous hematopoietic stem cell transplantation
On day 0 a minimal of 2 x 106 CD 34 cells/kg will be infused by central catheter according to institutional standards.
- Evaluate toxicity of the conditioning treatment regimen. [ Time Frame: 3 ¼ years ]
- Evaluate response and overall survival (OS). [ Time Frame: 3 ¼ years ]
- Determine what correlative laboratory and clinical parameters, if any, are associated with efficacy [ Time Frame: 3 ¼ years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00504101
|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|