Daratumumab

Generic Name: Daratumumab

Brand Names: Darzalex, Darzalex Faspro

Drug Type: Biotech

CAS Number: 945721-28-8

Unique Ingredient Identifier: 4Z63YK6E0E

Background: Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab. It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.

Daratumumab was granted FDA approval on 16 November 2015. It is approved for the treatment of multiple myeloma as monotherapy or combination therapy and light chain (AL) amyloidosis in combination with other drugs.

Indication: Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma. It is available as a combination product with hyaluronidase for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs.

Associated Conditions: Multiple Myeloma (MM), Primary Amyloidosis, Refractory Multiple Myeloma, Relapsed Multiple Myeloma

Clinical Trials

Daratumumab in Treatment of PGNMID and C3 GN

Phase 2

Completed

Conditions: Membranoproliferative Glomerulonephritis

Interventions: Drug: Daratumumab

First Posted Date: 2017-03-29

Last Posted Date: 2022-08-31

Lead Sponsor: Fernando Fervenza

Target Recruit Count: 12

Registration Number: NCT03095118

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Neoadjuvant Listeria or Daratumumab in Prostate Cancer

Phase 2

Withdrawn

Conditions: Prostate Cancer
Malignant Neoplasms of Male Genital Organs

Interventions: Drug: Daratumumab

First Posted Date: 2017-01-30

Last Posted Date: 2024-05-03

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT03035357

A Study of Daratumumab in Combination With Atezolizumab Compared With Atezolizumab Alone in Participants With Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: Drug: Atezolizumab
Drug: Daratumumab

First Posted Date: 2017-01-18

Last Posted Date: 2019-11-20

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 100

Registration Number: NCT03023423

Ixazomib Citrate, Lenalidomide, Dexamethasone, and Daratumumab in Treating Patients With Newly Diagnosed Multiple Myeloma

Phase 2

Completed

Conditions: Plasma Cell Myeloma

Interventions: Biological: Daratumumab
Drug: Dexamethasone
Drug: Ixazomib Citrate
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Other: Questionnaire Administration

First Posted Date: 2017-01-06

Last Posted Date: 2025-04-27

Lead Sponsor: Mayo Clinic

Target Recruit Count: 80

Registration Number: NCT03012880

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Study to Separately Evaluate the Activity of Talacotuzumab (JNJ-56022473) or Daratumumab in Transfusion-Dependent Participants With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Who Are Relapsed or Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment

Phase 2

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Talacotuzumab
Drug: Daratumumab

First Posted Date: 2017-01-05

Last Posted Date: 2025-03-04

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 34

Registration Number: NCT03011034

Locations: 🇺🇸
Washington University School Of Medicine, Saint Louis, Missouri, United States
🇺🇸
University of Pennsylvania Abramson Cancer Center, Philadelphia, Pennsylvania, United States
🇪🇸
Hosp Univ Vall D Hebron, Barcelona, Spain

and more 18 locations

2015-12: a Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Thalidomide
Drug: Dexamethasone
Drug: Daratumumab
Drug: Cisplatin
Drug: Adriamycin
Drug: Cyclophosphamide
Drug: Etoposide
Drug: Melphalan
Procedure: ASCT
Drug: Lenalidomide
Drug: Bortezomib

First Posted Date: 2016-12-28

Last Posted Date: 2024-10-09

Lead Sponsor: University of Arkansas

Target Recruit Count: 50

Registration Number: NCT03004287

Locations: 🇺🇸
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM)

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: DARATUMUMAB
Drug: DURVALUMAB

First Posted Date: 2016-12-22

Last Posted Date: 2018-10-16

Lead Sponsor: Celgene

Target Recruit Count: 18

Registration Number: NCT03000452

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States

and more 22 locations

Daratumumab in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma and Severe Renal Impairment

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2016-11-30

Last Posted Date: 2022-05-31

Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Target Recruit Count: 22

Registration Number: NCT02977494

Locations: 🇩🇪
Katholische Karl-Leisner Klinikum Goch, Goch, Germany
🇩🇪
Charité Universitätsmedizin BerlinCampus Benjamin Franklin, Berlin, Germany
🇩🇪
Asklepios Klinik Altona, Hamburg, Germany

and more 7 locations