Summary

Eligibility
for people ages 18-79 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

The purpose of this study is to evaluate conversion rate to minimal residual disease (MRD) negativity following the addition of daratumumab to lenalidomide relative to lenalidomide alone, when administered as maintenance treatment to anti-cluster of differentiation 38 (CD38) treatment naive participants with newly diagnosed multiple myeloma who are MRD positive as determined by next generation sequencing (NGS) at screening, following high-dose therapy (HDT) and autologous stem cell transplant (ASCT).

Official Title

A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Keywords

Multiple Myeloma, Plasma Cell Neoplasms, Residual Neoplasm, Lenalidomide, Daratumumab, Daratumumab + Lenalidomide

Eligibility

Locations

  • UCSF
    San Francisco California 94143 United States
  • UCLA David Geffen School of Medicine
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT03901963
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 200 people participating
Last Updated