Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial
Official title:
Phase I Clinical Trial of Dose Escalated Bortezomib + ATO (Arsenic Trioxide) + Melphalan as a Conditioning Regimen 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.
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.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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