Daratumumab

DARZALEX®

Overview

Daratumumab is a type of cancer drug called a monoclonal antibody. Daratumumab attaches to a protein called CD38, which is present in high numbers on the surface of multiple myeloma cells, as well as on certain other types of cells, such as red blood cells.

 

SparkCures ID 51
Developed By Johnson & Johnson
Brand Name Darzalex®
Generic Name Daratumumab
Additional Names CD38 mAb, HuMax-CD38
Treatment Classifications
Treatment Targets

Clinical Trials

All Clinical Trials

View all active clinical trials around the US.

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Untreated / Newly Diagnosed Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have been newly diagnosed or have not yet received treatment.

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Early Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received one to two prior lines of therapy.

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Late Relapse Multiple Myeloma

The following is a listing of clinical trials for patients with multiple myeloma who have received three or more prior lines of therapy.

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Smoldering Myeloma

The following is a listing of clinical trials for patients with Smoldering Myeloma.

Monoclonal Gammopathy of Undetermined Significance (MGUS)

Published Results

TECVAYLI® plus DARZALEX FASPRO® combination regimen significantly improves progression-free survival and overall survival versus standard of care

October 16, 2025

Johnson & Johnson (NYSE:JNJ), the worldwide leader in multiple myeloma therapies, today announced positive topline results from the investigational Phase 3 MajesTEC-3 study. The study evaluates the efficacy and safety of TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) versus investigator’s choice of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) or DARZALEX FASPRO, bortezomib, and dexamethasone (DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who received one to three prior lines of therapy.1

At almost three years follow-up, the combination of TECVAYLI and DARZALEX FASPRO met the primary endpoint of progression-free survival (PFS) (the time a treatment keeps a patient’s cancer from progressing or death) and the results were statistically significant and superior to standard of care.2 The secondary endpoint of overall survival (OS) was also statistically significant at this first interim analysis.2

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