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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Southwest Oncology Group Cancer and Leukemia Group B National Cancer Institute of Canada European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002878 |
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.
Condition | Intervention | Phase |
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Multiple Myeloma and Plasma Cell Neoplasm |
Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: valspodar Drug: vincristine sulfate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 Start Date: | March 1997 |
OBJECTIVES:
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:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Multiple myeloma of any stage confirmed by:
Measurable disease by at least one of the following:
Serum M-component at least 1.0 g/dL by electrophoresis
The following are not considered measurable but are followed for response:
Objective evidence of progression by at least one of the following:
Increased serum M-protein (by electrophoresis unless M-spike less than 1.5 g/dL)
Increased urine M-protein
Increase in serum or urine M-protein by 25% to under 50% (as above) plus one of the following:
Hemoglobin decreased by more than 2.0 g/dL not attributed to chemotherapy, interferon therapy, or a myelodysplastic syndrome
Failure of prior cytotoxic therapy defined by one of the following:
Adequate prior chemotherapy required, e.g.:
At least 2 courses of combination chemotherapy (e.g., VBMCP, VBAP, MP)
Prior vincristine, doxorubicin, and dexamethasone (VAD) allowed
Prior autologous peripheral blood stem cell transplant allowed if performed prior to development of drug resistance
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
No arrhythmia requiring therapy (i.e., sustained atrial or ventricular arrhythmia or multifocal premature ventricular contraction)
Neurologic:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | William R. Friedenberg, MD | Guthrie Cancer Center at Guthrie Clinic Sayre |
Study Chair: | Karl H. Hanson, MD | Saint Luke's Cancer Institute at Saint Luke's Hospital |
Study Chair: | Richard A. Larson, MD | University of Chicago |
Study Chair: | Chaim Shustik, MD | Royal Victoria Hospital - Montreal |
Study Chair: | Pieter Sonneveld, MD, PhD | University Medical Center Rotterdam at Erasmus Medical Center |
Study ID Numbers: | CDR0000065178, E-1A95, CAN-NCIC-MY8, CLB-E1A95, EORTC-E1A95/06971, SWOG-E1A95, CAN-NCIC-J1A95, CLB-9596, SWOG-S1A95 |
Study First Received: | November 1, 1999 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00002878 History of Changes |
Health Authority: | United States: Federal Government |
refractory multiple myeloma |
Dexamethasone Anti-Inflammatory Agents Blood Protein Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Hemostatic Disorders Hormones Anti-Bacterial Agents Hemorrhagic Disorders Dexamethasone acetate Immunoproliferative Disorders Antineoplastic Agents, Hormonal |
Hematologic Diseases Blood Coagulation Disorders Vascular Diseases Vincristine Antimitotic Agents Glucocorticoids Doxorubicin Multiple Myeloma Tubulin Modulators Peripheral Nervous System Agents Lymphoproliferative Disorders Antineoplastic Agents, Phytogenic Neoplasms, Plasma Cell |
Anti-Inflammatory Agents Dexamethasone Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Blood Protein Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Paraproteinemias Antibiotics, Antineoplastic Hemostatic Disorders Hormones Hemorrhagic Disorders Therapeutic Uses Cardiovascular Diseases |
Dexamethasone acetate Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Hematologic Diseases Mitosis Modulators Gastrointestinal Agents Vascular Diseases Vincristine Antimitotic Agents Glucocorticoids Doxorubicin Pharmacologic Actions Multiple Myeloma |