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
- 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
PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study within 1 year.
Masking: Open Label, Primary Purpose: Treatment
Millennium Pharmaceuticals, Inc.
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|