IRB #

STUDY00019855

Title

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

Principal Investigator

Rebecca Silbermann

Study Purpose

The purpose of the study is to find out whether treatment with daratumumab and lenalidomide improves disease response in multiple myeloma. You will receive either lenalidomide alone, or both lenalidomide and daratumumab. A computer will by chance assign you to treatment groups in the study. This is called randomization. You will have a 50% chance of being in either group.

Medical Condition(s)

Multiple myeloma

Eligibility Criteria

- Men and women 18-79 years of age with newly diagnosed multiple myeloma who are Minimal Residual Disease positive after frontline autologous stem cell transplant (ASCT)
- You must not have had prior treatment with an anti-CD38 antibody, such as daratumumab

Age Range

18 - 79

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug(s) until your disease gets worse, the side effects become too severe, or you complete 36 cycles (about 3 years). After you finish the study drug(s), the investigator will continue to watch you for side effects and follow your condition for up to 4 years.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Janssen Research & Development, LLC.

Recruitment End

04/25/2021

Compensation Provided

No


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