Spots Global Cancer Trial Database for Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma
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Trial Identification
Brief Title: Combination Chemotherapy With or Without PSC 833 in Treating Patients With Relapsed or Refractory Multiple Myeloma
Official Title: 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
Study ID: NCT00002878
Study Description
Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining PSC 833 with chemotherapy may reduce resistance to the drug, and allow more tumor cells to be killed. It is not yet known whether combination chemotherapy plus PSC 833 is more effective than combination chemotherapy alone in treating patients with relapsed or refractory multiple myeloma. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without PSC 833 in treating patients with relapsed or refractory multiple myeloma.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California San Diego Cancer Center, La Jolla, California, United States
UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States
CCOP - Christiana Care Health Services, Wilmington, Delaware, United States
Walter Reed Army Medical Center, Washington, District of Columbia, United States
CCOP - Mount Sinai Medical Center, Miami Beach, Florida, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Holden Comprehensive Cancer Center at The University of Iowa, Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore, Maryland, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Ellis Fischel Cancer Center - Columbia, Columbia, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
CCOP - Southern Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
CCOP - North Shore University Hospital, Manhasset, New York, United States
Schneider Children's Hospital at North Shore, Manhasset, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
New York Presbyterian Hospital - Cornell Campus, New York, New York, United States
Mount Sinai Medical Center, NY, New York, New York, United States
State University of New York - Upstate Medical University, Syracuse, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC, Chapel Hill, North Carolina, United States
Duke Comprehensive Cancer Center, Durham, North Carolina, United States
CCOP - Southeast Cancer Control Consortium, Winston-Salem, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Rhode Island Hospital, Providence, Rhode Island, United States
University of Tennessee, Memphis Cancer Center, Memphis, Tennessee, United States
Vermont Cancer Center, Burlington, Vermont, United States
MBCCOP - Massey Cancer Center, Richmond, Virginia, United States
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Moncton Hospital, Moncton, New Brunswick, Canada
Cancer Care Ontario-London Regional Cancer Centre, London, Ontario, Canada
Hotel Dieu Health Sciences Hospital - Niagara, St. Catharines, Ontario, Canada
Toronto General Hospital, Toronto, Ontario, Canada
Cancer Care Ontario - Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
McGill University, Montreal, Quebec, Canada
Contact Details
Name: William R. Friedenberg, MD
Affiliation: Guthrie Cancer Center at Guthrie Clinic Sayre
Role: STUDY_CHAIR
Name: Karl H. Hanson, MD
Affiliation: Saint Luke's Cancer Institute at Saint Luke's Hospital
Role: STUDY_CHAIR
Name: Richard A. Larson, MD
Affiliation: University of Chicago
Role: STUDY_CHAIR
Name: Chaim Shustik, MD
Affiliation: Royal Victoria Hospital - Montreal
Role: STUDY_CHAIR
Name: Pieter Sonneveld, MD, PhD
Affiliation: University Medical Center Rotterdam at Erasmus Medical Center
Role: STUDY_CHAIR
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