Thalidomide, Doxorubicin, and Dexamethasone in Treating Patients With Untreated Stage II or Stage III Multiple Myeloma

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title: A Phase II Clinical Trial Of Thalidomide, Adramycin And Dexamethasone (TAD) As Initial Therapy For The Treatment Of Multiple Myeloma

Status Completed

Clinical Trial Summary

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining thalidomide with chemotherapy may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of thalidomide, doxorubicin, and dexamethasone in treating patients who have untreated stage II or stage III multiple myeloma.

Clinical Trial Description

OBJECTIVES: I. Determine the response rate of patients with previously untreated stage II or III multiple myeloma treated with thalidomide, doxorubicin, and dexamethasone. II. Determine the safety and toxicity of this regimen in this patient population.

OUTLINE: Patients receive oral dexamethasone on days 1-4, 9-12, and 17-20, doxorubicin IV on day 1, and oral thalidomide daily. Treatment repeats every 30 days for 4 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 21-45 patients will be accrued for this study within approximately 1 year. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

• NCT number: NCT00008242
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: August 2000
• Completion date: January 2006