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
- 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.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate
Gordan Srkalovic, MD, PhD
Sparrow Regional Cancer Center
|Sparrow Regional Cancer Center||Lansing, Michigan 48912-1811|