Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
- Determine the time to progression in patients with relapsed or refractory multiple
myeloma (MM) treated with melphalan, arsenic trioxide, and ascorbic acid.
- Determine the response rate (combined complete response, partial response, and minimal
response) in patients treated with this regimen.
- Determine the safety and tolerability of this regimen in these patients.
- Determine the time to response and overall survival of patients treated with this
- Determine the effects of this regimen on renal failure associated with MM in these
OUTLINE: This is an open-label, non-randomized, multicenter study.
Patients receive oral melphalan once daily on days 1-4 of week 1 and arsenic trioxide (ATO)
IV over 1-2 hours and ascorbic acid IV over 15 minutes on days 1-4 of week 1 and then twice
weekly during weeks 2-5. Treatment repeats every 6 weeks for up to 6 courses in the absence
of disease progression or unacceptable toxicity. Patients with disease progression any time
after course 1 also receive oral prednisone once daily on days 1-4 and 22-25 of each course.
Patients achieving a complete response after 6 courses of therapy undergo bone marrow biopsy
and receive no further therapy. Patients achieving stable disease or a partial response
after 6 courses of therapy continue to receive ATO and ascorbic acid once weekly.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Primary Purpose: Treatment
James R. Berenson, MD
United States: Federal Government
|Abramson Cancer Center of the University of Pennsylvania||Philadelphia, Pennsylvania 19104-4283|
|Tulane Cancer Center at Tulane University Hospital and Clinic||New Orleans, Louisiana 70112|
|Hackensack University Medical Center Cancer Center||Hackensack, New Jersey 07601|
|William Beaumont Hospital - Royal Oak Campus||Royal Oak, Michigan 48073|
|Comprehensive Blood and Cancer Center||Bakersfield, California 93309|
|Mount Sinai Comprehensive Cancer Center at Mount Sinai Medical Center||Miami Beach, Florida 33140|
|Fountain Valley, California 92708|
|Palo Verde Hematology Oncology||Glendale, Arizona 85304|
|Oncotherapeutics||Los Angeles, California 90067|
|Southbay Oncology / Hematology Medical Group||Campbell, California 95008|
|Hematology-Oncology Medical Group of Fresno, Incorporated||Fresno, California 93720|
|Hematology Oncology Medical Group of Orange County, Incorporated||Orange, California 92868|
|Cancer Care Associates Medical Group - Redondo Beach||Redondo Beach, California 90277|
|Redwood Regional Oncology Center - Sotoyome||Santa Rosa, California 95405|
|Cancer Prevention and Treatment Center at Dominican and Watsonville Community Hospital||Soquel, California 95073|
|San Diego Cancer Center - Vista||Vista, California 92083|
|Atlanta Cancer Care - Roswell||Roswell, Georgia 30076|
|Center for Cancer and Blood Disorders at Suburban Hospital||Bethesda, Maryland 20817|
|Utah Cancer Specialists - Administrative Office||Salt Lake City, Utah 84106|