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Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab

NCT03871829 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2025-03-30

Study results available
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Summary

The purpose of this study is to compare the efficacy (rate of very good partial response \[VGPR\] or better as best response as defined by the International Myeloma Working Group \[IMWG\] criteria) of daratumumab subcutaneous (Dara-SC) in combination with carfilzomib and dexamethasone (Kd) with the efficacy of Kd in participants with relapsed refractory multiple myeloma who were previously exposed to daratumumab to evaluate daratumumab retreatment.

Conditions

Interventions

DRUG

Carfilzomib 20 mg/m^2

Carfilzomib 20 mg/m\^2 will be administered intravenously (IV).

DRUG

Carfilzomib 70 mg/m^2

Carfilzomib 70 mg/m\^2 will be administered IV.

DRUG

Dexamethasone 40 mg

Dexamethasone 40 mg will be administered as IV infusion or orally.

DRUG

Dara-SC 1800 mg

Dara-SC 1800 mg will be administered by SC injection.

DRUG

Dexamethasone 20 mg

Dexamethasone 20 mg will be administered as IV infusion or orally.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2022-10-24
Completion
2023-01-10
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Brazil
  • Canada
  • Denmark
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Poland
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

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 NCT03871829 on ClinicalTrials.gov