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Study #: BMT CTN 0702
Study Status: Open To Accrual (Enrolling)


A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma

This study is also known as: STaMINA

This trial is the follow‐up study to BMT CTN 0102 and BMT CTN 0704/CALGB 100104. It was developed by the Multiple Myeloma Inter‐Group, which includes representatives from SWOG, CALGB and ECOG as well as BMT CTN.


This study opened to accrual on June 1, 2010.

Abstracts:


Publication(s):
PMCID:  
Co-Principal Investigators:
Amrita Krishnan, MD
George Somlo, MD
Edward Stadtmauer, MD
 
Study Design:
The study is designed as a Phase III, multicenter trial of tandem autologous transplants plus maintenance therapy versus the strategy of single autologous transplant plus consolidation therapy with lenalidomide, bortezomib and dexamethasone (RVD) followed by maintenance therapy or single autologous transplant plus maintenance therapy as part of upfront treatment of multiple myeloma (MM). Lenalidomide will be used as maintenance therapy for three years in all arms.
Primary Objective:
The primary objective of the randomized trial is to compare three‐year progression free survival (PFS) between the three treatment arms as a pairwise comparison.
 
Seconday Objectives:
Secondary objectives are to:
  • compare disease response with rates of complete remission and very good partial remission (CR + VGPR);
  • compare the rate of CR conversion for patients not in CR at initiation of maintenance;
  • compare overall survival (OS);
  • compare the rate of Grade ≥ 3 toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0;
  • compare the incidence of infections;
  • compare the rate of treatment‐related mortality;
  • assess the rate of discontinuation of therapy; and
  • describe and compare quality of life in all three arms of the study.
Video Presentation:
View a video presentation about this protocol.

Study Contact

Cathy Gurgol OR Pam Panyutin, BMT CTN Protocol Coordinators cgurgol@emmes.com or ppanyutin@emmes.com

Learn More

Additional information on this protocol is available through the BMT CTM Website at:

 


Blood and Marrow Transplant
Last Updated: 11/23/2010 1:50 PM