A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

About this Study

The purpose of this study is to find out whether treatment with daratumumab and lenalidomide improves disease response in Multiple Myeloma.

Sponsor Protocol ID:l 54767414MMY3021
IRB Number:2019-0212
Actively Enrolling
Phase 3
September 24, 2019
Eligibility Criteria
18 years old
79 years old
Both Male and Female

Inclusion Criteria1. Must be 18 to 79 years of age. 

Exclusion Criteria1.  Be known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder).

 2.  Have any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

3.  Be pregnant, or breast-feeding, or planning to become pregnant or breast-feed while enrolled in this study or within 3 months after the last dose of study treatment(s). Or, if male, planning to father a child while enrolled in this study or within 3 months after the last dose of study treatment(s).

4.  Have had major surgery within 2 weeks before randomization or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study; kyphoplasty or vertebroplasty is not considered major surgery.

Have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before randomization or is currently enrolled in an interventional investigational study

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jennifer Barnes
Phone Number: 601-984-1964
Email: jbarnes@umc.edu
Principal Investigator:Elkins, Stephanie L, M.D.
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