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

NCT03236428 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-03-27

Study results available
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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

Conditions

  • Monoclonal Gammopathy
  • Smoldering Multiple Myeloma

Interventions

DRUG

Daratumumab

Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule

Sponsors & Collaborators

  • Janssen Pharmaceuticals

    collaborator INDUSTRY

  • Multiple Myeloma Research Consortium

    collaborator NETWORK

  • Blood Cancer Research Partnership

    collaborator OTHER

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Irene Ghobrial, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2021-10-04
Completion
2026-10-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03236428 on ClinicalTrials.gov