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Sponsors and Collaborators: |
University of Arkansas Celgene Corporation |
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Information provided by: | University of Arkansas |
ClinicalTrials.gov Identifier: | NCT00083876 |
This study has been designed to evaluate whether combination chemotherapy and "anti-angiogenesis" therapy with thalidomide is equal or superior to autologous transplantation for the treatment of multiple myeloma.
Condition | Intervention | Phase |
---|---|---|
Multiple Myeloma |
Drug: Thalidomide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | UARK 98-035, A Phase III Study of D.T. PACE Versus High Dose Melphalan and Autologous Transplant in Patients With Previously Treated Multiple Myeloma |
Estimated Enrollment: | 500 |
Study Start Date: | September 1998 |
Study Completion Date: | November 2007 |
All patients will receive two cycles, 4-6 weeks apart, of a combination of chemotherapy drugs (a regimen called D.T. PACE) and collection of peripheral blood stem cells. D.T. PACE consists of 6 chemotherapy drugs (Dexamethasone, Thalidomide, CisPlatin, Adriamycin, Cyclophoshamide, and Etoposide). Four to six weeks after the last cycle of D.T. PACE, each patient with no evidence of myeloma progression will be randomly assigned to receive 1) Autologous Transplant as described below or 2) Additional cycles of D.T. PACE. Since it is not known at this time which treatment is the best, patients will be placed by chance in one of the two groups. If tests show that myeloma is in remission at the time of randomization, 2 additional cycles of D.T. PACE will be given. If myeloma is not in remission, 2 additional cycles of D.T. PACE will be given, then the myeloma will be re-assessed. If the patients myeloma protein has decreased by 90% since baseline or better, 2 more cycles are given. If it has not decreased that much or has gotten worse, the patient will be offered autologous transplantation. Patients with no financial coverage for transplant, or those that have inadequate stem cell collections to support two transplants, will not be randomized and will proceed directly to treatment 2, continued D.T. PACE. If it is determined that the myeloma did not respond adequately to the first 2 cycles of D.T. PACE, then the patient will not be randomized and will proceed directly to autologous transplant.
Between 2 and 4 months after the first PBSC transplant, the patient will undergo a second course of high-dose Melphalan and PBSC transplant. In order for all patients to receive the maximum possible benefit, patients may "cross-over" to the other treatment arm if the myeloma does not go into complete remission or at any time myeloma progresses after randomization.
When the physician feels that the maximum benefit from chemotherapy has been received (best partial or complete remission) the last phase of the study will start, which is maintenance. Patients will be randomly assigned to receive either low dose (50 mg) or higher dose (200 mg) thalidomide with the dexamethasone.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arkansas | |
University of Arkansas for Medical Sciences/MIRT | |
Little Rock, Arkansas, United States, 72205 |
Principal Investigator: | Barthel Barlogie, M.D., Ph.D. | UAMS |
Responsible Party: | University_of_Arkansas ( Edwina Mosby, CRA ) |
Study ID Numbers: | UARK 98-035 |
Study First Received: | June 2, 2004 |
Last Updated: | December 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00083876 |
Health Authority: | United States: Food and Drug Administration |
Multiple Myeloma D.T. PACE Melphalan Transplant Thalidomide Dexamethasone Cisplatin |
Cyclophosphamide Doxorubicin Etoposide Filgrastim Interferon-alpha 2b Sargramostim |
Dexamethasone Melphalan Thalidomide Blood Protein Disorders Paraproteinemias Cyclophosphamide Hemostatic Disorders Etoposide phosphate Hemorrhagic Disorders Multiple myeloma Cisplatin Etoposide Dexamethasone acetate |
Interferon-alpha Immunoproliferative Disorders Hematologic Diseases Blood Coagulation Disorders Interferons Vascular Diseases Doxorubicin Multiple Myeloma Lymphoproliferative Disorders Interferon Alfa-2a Interferon Alfa-2b Neoplasms, Plasma Cell |
Anti-Infective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Anti-Bacterial Agents Neoplasms Therapeutic Uses Myeloablative Agonists Cardiovascular Diseases Growth Inhibitors Angiogenesis Modulating Agents Antineoplastic Agents, Alkylating Alkylating Agents Leprostatic Agents |