Phase II Study of Melphalan, Arsenic Trioxide, and Ascorbic Acid in Patients With Relapsed or Refractory Multiple Myeloma
OBJECTIVES:
Primary
- 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.
Secondary
- Determine the time to response and overall survival of patients treated with this
regimen.
- Determine the effects of this regimen on renal failure associated with MM in these
patients.
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.
Interventional
Primary Purpose: Treatment
James R. Berenson, MD
Study Chair
Oncotherapeutics
United States: Federal Government
CDR0000368637
NCT00085345
Name | Location |
---|---|
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 |