Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma

Phase 3

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Arm I	prednisone	Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.
Arm I	thalidomide	Patients receive oral thalidomide daily and oral prednisone every other day for 4 years in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measures

Name	Time	Method
Overall Survival	9 years	Number of patients died from any cause during the study.

Secondary Outcome Measures

Name	Time	Method
Disease Progression-free Survival	9 years	Number of patients with disease progression or death

Locations (18): Tom Baker Cancer Centre
🇨🇦
Calgary, Alberta, Canada
London Regional Cancer Program
🇨🇦
London, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston
🇨🇦
Kingston, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences
🇨🇦
Hamilton, Ontario, Canada
CancerCare Manitoba
🇨🇦
Winnipeg, Manitoba, Canada
BCCA - Vancouver Cancer Centre
🇨🇦
Vancouver, British Columbia, Canada
Odette Cancer Centre
🇨🇦
Toronto, Ontario, Canada
Dr. H. Bliss Murphy Cancer Centre
🇨🇦
St. John's, Newfoundland and Labrador, Canada
Hopital Maisonneuve-Rosemont
🇨🇦
Montreal, Quebec, Canada
QEII Health Sciences Center
🇨🇦
Halifax, Nova Scotia, Canada
Cross Cancer Institute
🇨🇦
Edmonton, Alberta, Canada
Saskatoon Cancer Centre
🇨🇦
Saskatoon, Saskatchewan, Canada
Centre hospitalier universitaire de Sherbrooke
🇨🇦
Sherbrooke, Quebec, Canada
McGill University - Dept. Oncology
🇨🇦
Montreal, Quebec, Canada
The Moncton Hospital
🇨🇦
Moncton, New Brunswick, Canada
CHA-Hopital Du St-Sacrement
🇨🇦
Quebec City, Quebec, Canada
Atlantic Health Sciences Corporation
🇨🇦
Saint John, New Brunswick, Canada