NCT00504101

Bortezomib, Arsenic Trioxide, and Melphalan in Treating Patients Undergoing an Autologous Stem Cell Transplant For Multiple Myeloma

Phase I Clinical Trial of Dose Escalated Bortezomib + ATO (Arsenic Trioxide) + Melphalan as a Conditioning Regimen for Multiple Myeloma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
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.
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.
DRUG	Melphalan	Melphalan will be given at 200 mg/m2 on day -2 (1 dose only)
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.

Timeline

• Start date: 2007-06-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2007-07-19
• Last updated: 2016-12-15

Locations

1 site across 1 country: United States