SWOG clinical trial number
CTSU/E3A06

Randomized Phase III Trial of Lenalidomide versus Observation Alone in Patients with Asymptomatic Smoldering Multiple Myeloma

Closed
Phase
Abbreviated Title
PIII Lenalidomide vs. Observation for SMM
Status Notes
E3A06 will close to accrual on 7/14/17, 5pm ET. Patients consented on 7/14/17 must be registered by 7/21/17, 5pm ET. If one more African American patient is not registered by 7/21/17, the African American cohort only will remain open to accrual.
Activated
02/01/2011
Closed
07/14/2017
Participants
CTSU

Research committees

Myeloma

Treatment

CC-5013 (Lenalidomide)

Eligibility Criteria Expand/Collapse

The Southwest Oncology Group has endorsed this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.

Publication Information Expand/Collapse

2020

Randomized Trial of Lenalidomide Versus Observation in Smoldering Multiple Myeloma

S Lonial;S Jacobus;R Fonseca;M Weiss;S Kumar;R Orlowski;J Kaufman;A Yacoub;F Baudi;T O'Brien;J Matous;D Anderson;D Emmons;A Mahrindra;L Wagner;M Dhodapkar;SV Rajkumar Journal of Clinical Oncology Apr 10;38(11):1126-1137

PMid: PMID31652094 | PMC number: PMC7145586

2019

E3A06: Randomized Phase III Trial of Lenalidomide versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma

S Lonial;S Jacobus;M Weiss;S Kumar;RZ Orlowski;J Kaufman;A Yacoub;F Buadi;T O'Brien;J Matous;D Anderson;R Emmons;M Dhodapkar;L Wagner;S Rajkumar J Clin Oncol 37(suppl; abstr 8001); American Society of Clinical Oncology (5/31 - 6/4/19, Chicago IL), oral

2012

Phase II Trial of Initial Safety and Toxicity Prior to the Phase III Trial of Lenalidomide Versus Observation Alone in Patients with Asymptomatic High-Risk Smoldering Multiple Myeloma (E3A06): A Trial Coordinated by the Eastern Cooperative Oncology Group

S Lonial;S Jacobus;M Weiss;R Fonseca;M Dhodapkar;SV Rajkumar Blood (ASH Annual Meeting) 120:abst 4079 (poster)

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