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 for Treatment of Proliferative Glomerulonephritis With Monoclonal Immune Deposits

Phase 2

Recruiting

Conditions: Proliferative Glomerulonephritis With Monoclonal IgG Deposits

Interventions: Drug: Daratumumab

First Posted Date: 2022-12-16

Last Posted Date: 2025-01-06

Lead Sponsor: Mayo Clinic

Target Recruit Count: 40

Registration Number: NCT05654506

Locations: 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
University North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
🇺🇸
Oregon Health and Science University, Portland, Oregon, United States

A Study of ANV419 Alone or in Combination With Approved Treatments in Patients With Multiple Myeloma (OMNIA-2)

Phase 1

Terminated

Conditions: Refractory Multiple Myeloma
Multiple Myeloma
Adult Disease
Relapsed Cancer
Hematologic Diseases

Interventions: Drug: ANV419
Drug: Lenalidomide with low-dose dexamethasone
Drug: Daratumumab

First Posted Date: 2022-12-07

Last Posted Date: 2024-02-12

Lead Sponsor: Anaveon AG

Target Recruit Count: 4

Registration Number: NCT05641324

Locations: 🇩🇰
Vejle Hospital, Vejle, Denmark
🇫🇷
CHU de Nantes - Hôtel-Dieu, Nantes, France
🇫🇷
Institut Paoli-Calmettes, Marseille, France

and more 8 locations

A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant

Phase 3

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Elranatamab
Drug: Daratumumab
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2022-11-21

Last Posted Date: 2025-05-13

Lead Sponsor: Pfizer

Target Recruit Count: 1116

Registration Number: NCT05623020

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇨🇳
Chang Gung Medical Foundation-Linkou Branch, Taoyuan, Taiwan
🇦🇺
Pindara Private Hospital, Benowa, Queensland, Australia

and more 60 locations

A Study of Modakafusp Alfa Together With Daratumumab Adults With Relapsed or Refractory Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Modakafusp Alfa
Drug: Daratumumab

First Posted Date: 2022-10-21

Last Posted Date: 2024-04-03

Lead Sponsor: Takeda

Target Recruit Count: 58

Registration Number: NCT05590377

Locations: 🇺🇸
Cedars-Sinai Medical Center, Los Angeles, California, United States
🇺🇸
HCA Midwest Health (Midwest Ventures Group HCA MidAmerica Division), Overland Park, Kansas, United States
🇺🇸
Fort Wayne Medical Oncology and Hematology, Inc, Fort Wayne, Indiana, United States

and more 24 locations

A Study to Investigate the Safety and Clinical Activity of Belantamab Mafodotin in Combination With Daratumumab, Pomalidomide and Dexamethasone in Patients With Relapsed/ Refractory Multiple Myeloma Previously Treated With One Line Therapy Who Are Lenalidomide Refractory

Phase 1

Not yet recruiting

Conditions: Multiple Myeloma
Gammopathy, Monoclonal
Paraproteinemias
Corneal Disease
Multiple Myeloma in Relapse
Neoplasms, Plasma Cell
Neoplasms
Blood Protein Disorders
Haematologic Disease

Interventions: Drug: Belantamab Mafodotin-Blmf
Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2022-10-17

Last Posted Date: 2022-10-17

Lead Sponsor: Hellenic Society of Hematology

Target Recruit Count: 48

Registration Number: NCT05581875

Study of Teclistamab in Combination in Elderly Patients With Multiple Myeloma

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Teclistamab
Drug: Daratumumab
Drug: Lenalidomide

First Posted Date: 2022-10-07

Last Posted Date: 2024-08-02

Lead Sponsor: University Hospital, Lille

Target Recruit Count: 74

Registration Number: NCT05572229

Locations: 🇫🇷
Chu Amiens - Hopital Sud, Amiens, France
🇫🇷
Chru Angers, Angers, France
🇫🇷
Ch D'Avignon, Avignon, France

and more 26 locations

A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia

Phase 2

Recruiting

Conditions: Immune Thrombocytopenia

Interventions: Drug: Daratumumab Injection

First Posted Date: 2022-10-03

Last Posted Date: 2025-02-24

Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Target Recruit Count: 20

Registration Number: NCT05562882

Locations: 🇨🇳
Chinese Academy of Medical Science and Blood Disease Hospital, Tianjin, Tianjin, China

Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Phase 3

Recruiting

Conditions: Plasma Cell Myeloma

Interventions: Drug: Daratumumab and Hyaluronidase-fihj
Drug: Bortezomib
Drug: Dexamethasone
Drug: Lenalidomide
Other: Quality-of-Life Assessment
Other: Questionnaire Administration

First Posted Date: 2022-09-30

Last Posted Date: 2024-05-06

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 510

Registration Number: NCT05561387

Locations: 🇺🇸
Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States
🇺🇸
Illinois CancerCare-Carthage, Carthage, Illinois, United States
🇺🇸
Saint Anthony's Health, Alton, Illinois, United States

and more 393 locations

Efficacy and Safety of Daratumumab in Combination With Bortezomib, Thalidomide, and Dexamethasone Regimens in Newly Diagnosed Multiple Myeloma

Not yet recruiting

Conditions: Newly Diagnosed Multiple Myeloma

First Posted Date: 2022-09-30

Last Posted Date: 2022-09-30

Lead Sponsor: The First Affiliated Hospital of Soochow University

Target Recruit Count: 120

Registration Number: NCT05561049

A Study of Modakafusp Alfa in Adult Participants With Multiple Myeloma

Phase 1

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Modakafusp alfa
Drug: Lenalidomide
Drug: Pomalidomide
Drug: Bortezomib
Drug: Carfilzomib
Drug: Daratumumab

First Posted Date: 2022-09-27

Last Posted Date: 2024-12-24

Lead Sponsor: Takeda

Target Recruit Count: 15

Registration Number: NCT05556616

Locations: 🇺🇸
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Gabrail Cancer Center Research, Canton, Ohio, United States
🇺🇸
Scripps Health, San Diego, California, United States

and more 18 locations

Drug Development Updates

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