Bortezomib and Dexamethasone in Treating Patients With Multiple Myeloma That Has Relapsed or Has Not Responded to Treatment
Recruitment status was: Recruiting
RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with dexamethasone works in treating patients with multiple myeloma that has relapsed or has not responded to treatment.
Multiple Myeloma and Plasma Cell Neoplasm
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Twice Weekly Induction Followed by Once Weekly IV Velcade (Bortezomib) With Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma Following at Least 1 Prior Therapy|
- Overall response rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
- Tolerability [ Designated as safety issue: Yes ]
- Duration of response after completion of treatment [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
- Overall and progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||March 2006|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
- Determine the overall response rate (complete response and partial response) in patients with relapsed or refractory multiple myeloma treated with induction therapy and maintenance therapy comprising bortezomib and dexamethasone.
- Determine the toxicity of this regimen in these patients
- Determine the tolerability of this regimen in these patients.
- Determine the duration of response in patients treated with this regimen.
- Determine time to progression in patients treated with this regimen.
- Determine overall and progression-free survival of patients treated with this regimen.
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11. Patients also receive oral dexamethasone on days 1, 2, 4, 5, 8, 9, 11, and 12. Treatment repeats every 21 days for 4 courses. Patients who achieve complete response (CR) receive an additional 2 courses of induction therapy and proceed to maintenance therapy.
- Maintenance therapy: Patients receive bortezomib IV on days 1, 8, 15, and 22. Patients also receive oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23. Treatment repeats every 36 days in the absence of disease progression or unacceptable toxicity. Patients who achieve CR receive an additional 2 courses of maintenance therapy beyond documentation of CR.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00389701
|United States, Michigan|
|Sparrow Regional Cancer Center|
|Lansing, Michigan, United States, 48909-7980|
|Study Chair:||Gordan Srkalovic, MD, PhD||Sparrow Regional Cancer Center|