Status: Closed
Activation Date: 2002SEP16
Closing Date: 2009JAN30
Phase: III
Description: A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant In Patients With Multiple Myeloma
Eligibility: Patients with histologically confirmed myeloma who had had an autologous stem cell transplant within one year of the beginning of initial treatment for their disease. Patients must be randomized within 60-100 days post transplant and have no other medical condition precluding long term use of prednisone or thalidomide.
Objective: Primary: to determine if maintenance treatment post transplant with thalidomide and prednisone (TP) prolongs overall survival compared with observation alone. Secondary: to determine if TP prolongs progression-free survival compared with observation alone; to compare quality of life, toxic effects, and the incidence of venous thromboembolism between the two patient groups. Correlative Studies Endpoints: to correlate FISH-identified chromosome translocations at relapse with clinical outcome in the two patient groups; to determine if there is evidence of increased thrombin generation in patients receiving TP as compared with those not.
Participation: Not limited
Lay Description: This research is being done because researchers believe that a combination of prednisone and thalidomide, given after autologous stem cell transplant, may slow down the return of myeloma. Nevertheless, because both thalidomide and prednisone have potentially serious side effects and might diminish quality of life, it is very important to determine whether or not these drugs are any better than no further treatment. Further, if they are better, are the side effects too great a price to pay?
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Hide Tissue Samples
Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
HEMATOLOGIC | MY10 | 332 | 0 | 0 | 0 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
HEMATOLOGIC | MY10 | 332 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
HEMATOLOGIC | MY10 | 332 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |