A Phase 3 Randomized, Multicenter Study of Subcutaneous Daratumumab Versus Active Monitoring in Subjects with High-risk Smoldering Multiple Myeloma

Principal Investigator

Eva Medvedova

Study Purpose

The main reason to do this study is to find out if it is better for smoldering multiple myeloma patients to receive treatment when they are diagnosed, or if therapy should be deferred until formal diagnostic criteria for multiple myeloma are met. The purpose of this study is to see if daratumumab, when given in early stage smoldering multiple myeloma, delays death or progression to multiple myeloma or if similar or better outcomes result if therapy is delayed until multiple myeloma is diagnosed. The answer to this question is currently unknown.

Medical Condition(s)

High-risk smoldering multiple myeloma

Eligibility Criteria

- Men and women at least 18 years of age
- Diagnosis of smoldering multiple myeloma for less than or equal to 5 years with measurable disease
- You must not have multiple myeloma requiring treatment

Age Range

18 - 99

Healthy Volunteers Needed


Duration of Participation

You are expected to participate in the study between 5 and 8 years. The timing when you join the study is determined by a number of factors, such as when you are diagnosed with smoldering multiple myeloma and when the investigator presents the study to you.

If you stop active monitoring (for example, should you progress to multiple myeloma) or the study drug (for example, should you progress to multiple myeloma or if you do not tolerate the study drug), we ask you to stay on the study for data collection, even if you are receiving a different therapy at that moment. This may help future patients.

Minors Included



Clinical Trials Information Line
Phone: 503-494-1080


Janssen Research & Development, LLC (is a pharmaceutical company of Johnson & Johnson)

Recruitment End


Compensation Provided


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