NCT00033332

Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma. PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Detailed description

OBJECTIVES: * Compare the response rate of patients with newly diagnosed multiple myeloma treated with dexamethasone with or without thalidomide. * Compare the toxicity of these regimens in these patients. * Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis grade and on the expression of vascular endothelial growth factor and basic fibroblast growth factor in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients also receive either pamidronate IV over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening. * Arm II: Patients receive dexamethasone and pamidronate or zoledronate as in arm I. Treatment in both arms repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses after the fourth course at the physician's discretion. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years. PROJECTED ACCRUAL: A total of 194 patients (97 per treatment arm) will be accrued for this study.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
DRUG	dexamethasone
DRUG	pamidronate disodium
DRUG	thalidomide
DRUG	zoledronic acid

Timeline

• Start date: 2002-04-01
• Primary completion: 2006-03-01
• Completion: 2006-06-01
• First posted: 2003-01-27
• Last updated: 2014-04-04

Locations

78 sites across 3 countries: United States, Puerto Rico, South Africa