Multiple Myeloma Clinical Trial
Official title:
A Phase III Trial of Dexamethasone, Cyclophosphamide, Etoposide, Cisplatin (DCEP) and G-CSF With or Without Thalidomide (NSC #66847) as Salvage Therapy for Patients With Refractory Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Thalidomide may stop the growth of tumor cells by stopping
blood flow to the tumor. It is not yet known if combination chemotherapy is more effective
with or without thalidomide for multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy
with or without thalidomide in treating patients who have refractory multiple myeloma.
OBJECTIVES: I. Compare the overall and progression-free survival and remission rates in
patients with refractory multiple myeloma treated with dexamethasone, cyclophosphamide,
etoposide, cisplatin, and filgrastim (G-CSF) with or without thalidomide. II. Compare the
qualitative and quantitative toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior
transplantation (yes vs no), prior treatment failure (resistant vs relapsing), prior
treatment regimens (1-2 vs 3-4), and prior thalidomide (no vs some). Patients are randomized
to one of two treatment arms. Arm I: Patients receive oral dexamethasone daily and
cyclophosphamide, etoposide, and cisplatin (DCEP) IV continuously on days 1-4. Patients also
receive filgrastim (G-CSF) subcutaneously daily beginning on day 5 and continuing until
blood counts recover. Treatment continues every 3-4 weeks for 3 courses. Patients achieving
stable disease or better proceed to maintenance chemotherapy with DCEP administered every 8
weeks for 3 additional courses. Arm II: Patients receive chemotherapy with DCEP as in arm I
plus oral thalidomide daily. Thalidomide continues with maintenance chemotherapy and then
continues after chemotherapy is completed until disease progression. Patients are followed
every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 320 patients will be accrued for this study within 4 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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