drugset / Trial / NCT00005834

S9922 Combination Chemo Plus Filgrastim With or Without Thalidomide in Refractory Multiple Myeloma

NCT00005834

RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2000-04
Primary completion
2003-11
Completion
2007-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Thalidomide Other / unclassified 800 mg Oral
Background Cisplatin Other / unclassified 15 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 400 mg/m2 Intravenous
Background Dexamethasone Small molecule 40 mg Oral
Background Etoposide Small molecule 40 mg/m2 Intravenous
Background filgrastim Protein / enzyme biologic 300 ug Subcutaneous
Background filgrastim Protein / enzyme biologic 480 ug Subcutaneous

Indications