drugset / Trial / NCT00258245

Arsenic Trioxide and Ascorbic Acid Combined With Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma or Plasma Cell Leukemia

NCT00258245

NaSingle-groupOpen-labelTreatment

Summary

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Ascorbic acid may help arsenic trioxide work better by making cancer cells more sensitive to the drug. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Thalidomide may stop the growth of cancer cells by stopping blood flow to the cancer. Giving arsenic trioxide and ascorbic acid together with bortezomib, thalidomide, and dexamethasone may stop the growth of and kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide when given together with ascorbic acid, bortezomib, thalidomide, and dexamethasone in treating patients with relapsed or refractory multiple myeloma or plasma cell leukemia.

Timeline

Start
2005-05
Primary completion
2008-04
Completion
2008-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Vitamin C Other / unclassified 1000 mg Intravenous
Subject arsenic trioxide Small molecule 0.1 mg/kg Intravenous
Subject arsenic trioxide Small molecule 0.15 mg/kg Intravenous
Subject arsenic trioxide Small molecule 0.25 mg/kg Intravenous
Background Aspirin Small molecule 325 mg Oral
Background Bortezomib Small molecule 1 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg Intravenous
Background Thalidomide Other / unclassified 50 mg Oral

Indications