A Phase II Trial of Bortezomib + Ascorbic Acid + Melphalan (BAM) Combination Therapy for Patients With Newly Diagnosed Multiple Myeloma
- Determine the overall response rate (combined complete response [CR], near CR, partial
response [PR], and minimal response [MR]) and time to progression of disease in
patients with newly diagnosed multiple myeloma treated with bortezomib, ascorbic acid,
- Assess the safety and tolerability of this regimen in these patients.
- Assess the time to response in these patients.
- Determine progression-free and overall survival of these patients.
- Assess time to disease progression among subjects who continue to maintenance treatment
OUTLINE: This is an open-label study.
- Induction therapy: Patients receive bortezomib IV on days 1, 4, 8, and 11 and oral
melphalan and oral ascorbic acid on days 1-4. Treatment repeats every 28 days to
maximum response [MR] or for at least 8 courses in the absence of disease progression
or unacceptable toxicity. Patients with responding disease receive an additional 2
courses of induction therapy beyond MR and proceed to maintenance therapy. Patients
with stable disease or without a maximum reduction in their paraprotein after 8 courses
of induction therapy are eligible to receive maintenance therapy.
- Maintenance therapy: Patients receive bortezomib IV on days 1 and 15. Treatment repeats
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Overall response rate (complete response [CR], near CR, partial response, and minimal response)
James R. Berenson, MD
United States: Federal Government
|University of Chicago Cancer Research Center||Chicago, Illinois 60637|
|SUNY Downstate Medical Center||Brooklyn, New York 11203|
|Florida Oncology Associates||Orange Park, Florida 32073|
|Oncotherapeutics||Los Angeles, California 90067|
|Hematology-Oncology Medical Group of Fresno, Incorporated||Fresno, California 93720|
|Hematology Oncology Medical Group of Orange County, Incorporated||Orange, California 92868|
|Atlanta Cancer Care - Roswell||Roswell, Georgia 30076|
|Florida Cancer Specialists - Bonita Springs||Bonita Springs, Florida 34135|