PS-341 in Treating Patients With Refractory or Progressive Multiple Myeloma
Recruitment status was Active, not recruiting
RATIONALE: PS-341 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. It is not yet known if PS-341 is effective in treating patients who have multiple myeloma.
PURPOSE: Randomized phase III trial to study the effectiveness of PS-341 in treating patients who have refractory or progressive multiple myeloma.
Multiple Myeloma and Plasma Cell Neoplasm
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An International, Non-Comparative, Open-Label Study of PS-341 Administered to Patients With Multiple Myeloma Who Experienced Relapsed or Progressive Disease After Receiving at Least Four Previous Treatment Regimens or Experienced Progressive Disease After Receiving Dexamethasone in FHCRC Protocol 1746.00|
|Study Start Date:||July 2002|
- Determine the time to progressive disease in patients with refractory or progressive multiple myeloma treated with PS-341.
- Determine the safety and tolerability of this drug in these patients.
- Determine survival of patients treated with this drug.
- Determine the rate and duration of response (complete and partial) in patients treated with this drug.
- Assess the relationship between selected genetic disease markers and response in patients treated with this drug.
OUTLINE: This is an open-label, multicenter study.
- Induction therapy: Patients receive PS-341 IV on days 1, 4, 8, and 11. Treatment repeats every 3 weeks for up to 8 courses.
- Maintenance therapy: Patients receive PS-341 IV on days 1, 8, 15, and 22. Treatment repeats every 5 weeks for up to 3 courses.
Patients who experience progressive disease (PD) after at least 2 courses or no change after at least 4 courses may also receive oral dexamethasone on the day of and the day after PS-341 administration. Patients who experience PD after at least 2 courses of this combined therapy go off study.
Patients are followed at 30 days, every 6 weeks until disease progression, and then every 3 months thereafter.
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 1 year.
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Study Chair:||Denise Collins||Millennium Pharmaceuticals, Inc.|