Thalidomide and Prednisone After Autologous Stem Cell Transplantation Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00049673|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 2, 2020
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|
|Actual Study Start Date :||September 16, 2002|
|Actual Primary Completion Date :||July 7, 2010|
|Actual Study Completion Date :||September 19, 2013|
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.
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049673
|Study Chair:||A. Keith Stewart, MD||Mayo Clinic|
|Study Chair:||Martha Q. Lacy, MD||Mayo Clinic|