NCT03236428

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

This research study is a Phase II clinical trial, which tests the effectiveness of an investigational drug. Preliminary experience suggests that daratumumab may prevent or postpone SMM from becoming active multiple myeloma. The purpose of this research study is to determine if the this drug may improve the rate of prevention of multiple myeloma. Multiple myeloma is a cancer of the plasma cell, which is an important part of the immune system. Patients with active multiple myeloma generally require treatment. There are currently no approved therapies for smoldering multiple myeloma or Monoclonal Gammopathy of Unknown Significance. Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule, which is over-expressed in multiple myeloma cells. This type of drug is called a monoclonal antibody. The FDA (the U.S. Food and Drug Administration) has not approved Daratumumab for the participant specific disease but it has been approved for use in active Multiple Myeloma.

Conditions

• Monoclonal Gammopathy
• Smoldering Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-11-24
• Primary completion: 2021-10-04
• Completion: 2026-10-04
• First posted: 2017-08-01
• Last updated: 2026-03-27
• Results posted: 2026-03-27

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study