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NCT03236428 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Smoldering Multiple Myeloma and Monoclonal Gammopathy, sponsored by Dana-Farber Cancer Institute.

Active
Registry status
Phase 2
Development phase
42
Enrollment target
6
Study locations

NCT03236428: Active Phase 2 study of Smoldering Multiple Myeloma and Monoclonal Gammopathy, sponsored by Dana-Farber Cancer Institute.

NCT03236428 is a Phase 2 study of Smoldering Multiple Myeloma and Monoclonal Gammopathy that is active but no longer recruiting, run by Dana-Farber Cancer Institute. The registered enrollment target is 42 participants, below the 798-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (95% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03236428, a Phase 2 study of Smoldering Multiple Myeloma and Monoclonal Gammopathy, is active but no longer recruiting, sponsored by Dana-Farber Cancer Institute.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
42 participants
Enrollment target
6
Study locations

Study 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

Primary Outcome

To determine the proportion of patients who are in VGPR or better after twenty cycles of therapy with Daratumumab. This will be determined at the time of best overall response.

Interventions

  • DRUG Daratumumab

Study Locations (6)

Massachusetts

  • Massachusetts General Hospital - Boston
  • Beth Israel Deaconess Medical Center - Boston
  • Dana Farber Cancer Institute - Boston

California

  • Pacific Cancer Care - Monterey

Colorado

  • Colorado Blood Cancer Institute - Denver

Michigan

  • Karmanos Cancer Insitute - Detroit

Trial Details

FieldValue
Enrollment Target 42 participants
Start Date 2017-11-24
Est. Completion 2026-10-04
Phase Phase 2
Dana-Farber Cancer Institute

781 total trials

What the registry record for NCT03236428 still lists

NCT03236428 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 798-participant average among 20 other Smoldering Multiple Myeloma trials with a reported enrollment target (95% lower).

The record links to 2 conditions, with Smoldering Multiple Myeloma appearing as the primary indexed condition, and to 1 intervention - of which Daratumumab is the first listed.

NCT03236428 lists 6 locations in 4 states (Massachusetts, California, Colorado).

Frequently Asked Questions

What is clinical trial NCT03236428 about?

NCT03236428 is a clinical study titled "Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma". 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

What is the current status of trial NCT03236428?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2017-11-24. Estimated completion is 2026-10-04.

What conditions does trial NCT03236428 study?

This clinical trial studies the following conditions: Smoldering Multiple Myeloma, Monoclonal Gammopathy.

What interventions are being tested in trial NCT03236428?

The interventions under investigation include: Daratumumab (DRUG).

Who is sponsoring clinical trial NCT03236428?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03236428 being conducted?

This trial has 6 study locations across California, Colorado, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Smoldering Multiple Myeloma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03236428's enrollment target sits among peer trials

42 16th of 20 higher than 5 of 20 other Smoldering Multiple Myeloma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Smoldering Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03236428, the US trial registry maintained by the National Library of Medicine. NCT03236428 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.