A PHASE III STUDY OF PSC-833 IN COMBINATION WITH VINCRISTINE, DOXORUBICIN AND DEXAMETHASONE (PSC-833/VAD) VERSUS VAD ALONE IN PATIENTS WITH RELAPSING OR REFRACTORY MULTIPLE MYELOMA
OBJECTIVES:
- Compare the overall survival and objective response rate of patients with relapsed or
refractory multiple myeloma treated with vincristine, doxorubicin, and dexamethasone
(VAD) with or without PSC 833.
- Compare event free survival and subjective response in patients treated with these
regimens.
- Correlate treatment outcome with p-glycoprotein expression.
- Determine whether prognostic factors previously determined to be useful in untreated
patients (i.e., plasma cell labeling index and multidrug resistance determined from
bone marrow aspirates, serum beta 2-microglobulin and interleukin-6 receptor levels)
correlate with objective and subjective response and event-free and overall survival in
patients treated with these regimens.
- Compare the toxicity of VAD with or without PSC 833.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by response to
prior treatment, prior doxorubicin and/or vincristine, prior autologous peripheral blood
stem cell transplantation, and center.
Patients are randomized to 1 of 2 treatment arms:
- Arm I: The first group receives vincristine, doxorubicin, and dexamethasone (VAD).
Patients receive higher dose vincristine IV over 96 hours and higher dose doxorubicin
IV over 96 hours on days 1-4 and oral dexamethasone daily on days 1-4 and 15-18.
- Arm II: The second group receives VAD plus oral PSC 833. Patients receive oral PSC 833
every 6 hours beginning on day 1 and continuing for 20 doses. Patients receive lower
dose vincristine IV over 96 hours and lower dose doxorubicin IV over 96 hours on days
2-5 and oral dexamethasone daily on days 2-5 and 16-19.
Treatment in both arms repeats every 4 weeks in the absence of disease progression or
unacceptable toxicity. After completion of 2 courses, patients are reevaluated, and those
with stable or responding disease continue treatment for 2 courses beyond maximum response.
Doxorubicin is discontinued in patients who receive a maximum lifetime dose but still have
stable or responding disease.
Patients are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study over approximately
20 months.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
William R. Friedenberg, MD
Study Chair
Guthrie Cancer Center at Guthrie Clinic Sayre
United States: Federal Government
CDR0000065178
NCT00002878
March 1997
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Walter Reed Army Medical Center | Washington, District of Columbia 20307-5000 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
University of Massachusetts Memorial Medical Center | Worcester, Massachusetts 01655 |
University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
Rhode Island Hospital | Providence, Rhode Island 02903 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
University of California San Diego Cancer Center | La Jolla, California 92093-0658 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore, Maryland 21201 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Barnes-Jewish Hospital | Saint Louis, Missouri 63110 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
State University of New York - Upstate Medical University | Syracuse, New York 13210 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
MBCCOP - Massey Cancer Center | Richmond, Virginia 23298-0037 |
Mount Sinai Medical Center, NY | New York, New York 10029 |
New York Presbyterian Hospital - Cornell Campus | New York, New York 10021 |
Holden Comprehensive Cancer Center at The University of Iowa | Iowa City, Iowa 52242-1009 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |
Schneider Children's Hospital at North Shore | Manhasset, New York 11030 |