Thalidomide and Prednisone After Autologous Stem Cell Transplantation in Treating Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00049673|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 6, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma and Plasma Cell Neoplasm||Drug: prednisone Drug: thalidomide||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||332 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Phase III Study Of Thalidomide And Prednisone As Maintenance Therapy Following Autologous Stem Cell Transplant in Patients With Multiple Myeloma|
|Study Start Date :||September 2002|
|Primary Completion Date :||February 2010|
|Study Completion Date :||September 2013|
U.S. FDA Resources
Experimental: 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.
Given orallyDrug: thalidomide
No Intervention: Arm II
Patients undergo observation.
- Overall survival [ Time Frame: 11 years ]
- Time to progression after reaching primary endpoint [ Time Frame: 11 years ]
- Toxicity assessed by NCI CTC v2.0 [ Time Frame: 11 years ]
- Quality of life assessed by EORTC QLQ C30 questionnaire [ Time Frame: 11 years ]
- Incidence of venous thrombosis determined by objective imaging [ Time Frame: 11 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049673
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada, T2N 4N2|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Canada, British Columbia|
|BCCA - Vancouver Cancer Centre|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Winnipeg, Manitoba, Canada, R3E 0V9|
|Canada, New Brunswick|
|The Moncton Hospital|
|Moncton, New Brunswick, Canada, E1C 6Z8|
|Atlantic Health Sciences Corporation|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Canada, Newfoundland and Labrador|
|Dr. H. Bliss Murphy Cancer Centre|
|St. John's, Newfoundland and Labrador, Canada, AIB 3V6|
|Canada, Nova Scotia|
|QEII Health Sciences Center|
|Halifax, Nova Scotia, Canada, B3H 1V7|
|Juravinski Cancer Centre at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Centre of Southeastern Ontario at Kingston|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Program|
|London, Ontario, Canada, N6A 4L6|
|Odette Cancer Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Univ. Health Network-Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Montreal, Quebec, Canada, H1T 2M4|
|McGill University - Dept. Oncology|
|Montreal, Quebec, Canada, H2W 1S6|
|CHA-Hopital Du St-Sacrement|
|Quebec City, Quebec, Canada, G1S 4L8|
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Saskatoon Cancer Centre|
|Saskatoon, Saskatchewan, Canada, S7N 4H4|
|Study Chair:||A. Keith Stewart, MD||Mayo Clinic|
|Study Chair:||Martha Q. Lacy, MD||Mayo Clinic|