Active — Not RecruitingPhase 2

Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma

United States42 participantsStarted 2017-11-24

Plain-language summary

This research study is studying a drug as a possible treatment for Monoclonal Gammopathy of Unknown Significance (MGUS) or Smoldering Multiple Myeloma (SMM). The drug involved in this study is: -Daratumumab

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓--≥ 10% Bone Marrow Plasma Cells
✓No evidence of CRAB criteria† or new criteria of active MM which including the following:
✓--Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months)

What they're measuring

The Proportion Of Patients In Deep Response

Timeframe: 2 years

Trial details

NCT IDNCT03236428

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-04

Results submitted2026-02-17

View on ClinicalTrials.gov More Monoclonal Gammopathy trials