Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 332
Healthy volunteers: no

Brief summary:
RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. It is not yet known whether combining thalidomide with prednisone and giving them after autologous stem cell transplantation may be effective in treating multiple myeloma.

PURPOSE: This randomized phase III trial is studying thalidomide and prednisone to see how well they work compared to observation in treating patients who have undergone stem cell transplantation for multiple myeloma.

Detailed description:
OBJECTIVES:

* Compare overall survival of patients with multiple myeloma treated with thalidomide and prednisone as maintenance therapy vs observation alone after autologous stem cell transplantation.
* Compare progression-free survival of patients treated with these regimens.
* Compare quality of life of patients treated with these regimens.
* Compare toxic effects of these regimens in these patients.
* Compare the objective venous thromboembolism rate in symptomatic patients treated with these regimens.

OUTLINE: This is a randomized, non-blinded, multicenter study. Patients are stratified according to treatment center, age (under 60 vs 60 and over), and response to prior transplantation (complete vs incomplete). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo observation.

For both arms, patients are assessed (including for quality of life) regularly throughout the treatment/observation period: at baseline, every 2 months for 6 months, every 3 months for up to 4 years, and then annually thereafter.

After the treatment/observation period, patients are followed annually..

PROJECTED ACCRUAL: A total of 324 patients will be accrued for this study within 3.5 years.

Arms:
arm 1: Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity. arm 2: Patients undergo observation.

Interventions: intervention 1: prednisone intervention 2: thalidomide
Intervention descriptions: intervention 1: Given orally intervention 2: Given orally

Protocol document: