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A Study of Daratumumab

NCT05438043 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-05-08

No results posted yet for this study

Summary

The purpose of this study is to provide ongoing access to study treatments for participants with multiple myeloma or smoldering multiple myeloma benefiting from treatment in certain Janssen Research and Development (R\&D) studies that use daratumumab as part of the study treatment regimen: access for all participants regardless of treatment group in daratumumab studies and access to participants in daratumumab-containing arms in the non-daratumumab studies will be allowed from studies which have reached clinical cutoff for final analysis. Certain long-term safety data will continue to be collected from study participants.

Conditions

Interventions

DRUG

Daratumumab

Daratumumab will be administered either intravenously or subcutaneously.

DRUG

Carfilzomib

Carfilzomib will be administered intravenously.

DRUG

Dexamethasone

Dexamethasone will be administered either orally or intravenously.

DRUG

Lenalidomide

Lenalidomide will be administered orally.

DRUG

Pomalidomide

Pomalidomide will be administered orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2029-01-31
Completion
2029-01-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Poland
  • Russia
  • South Korea
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05438043 on ClinicalTrials.gov