Phase II Study of VDT (VELCADE, Doxil® and Thalidomide) as Frontline Therapy for Patients With Previously Untreated Multiple Myeloma (MM)
- To determine the overall response rate (complete response and partial response) in
patients previously untreated stage I, II, or III multiple myeloma.
- To evaluate the complete response rate in patients treated with this regimen.
- To determine the time to disease progression from the start of this therapy in patients
treated with this regimen.
OUTLINE: Patients receive low-dose oral thalidomide once a day on days 1-28, bortezomib IV
on days 1, 4, 15, and 18, and doxorubicin hydrochloride liposome IV over 60-90 minutes on
days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease
progression or unacceptable toxicity. Patients with residual disease who continue to show
response after completion of 6 courses may receive 2 additional courses for a total of 8
After completion of study treatment, patients are followed every 3 months.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete and partial)
Every 3 months
Kelvin Lee, MD
Roswell Park Cancer Institute
United States: Food and Drug Administration
|Roswell Park Cancer Institute||Buffalo, New York 14263|