Daratumumab

Generic Name
Daratumumab
Brand Names
Darzalex, Darzalex Faspro
Drug Type
Biotech
Chemical Formula
-
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.
...

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
Associated Therapies
-

A Study to Determine Dose, Safety, Tolerability, Drug Levels, and Efficacy of CC-220 Monotherapy, and in Combination With Other Treatments in Participants With Multiple Myeloma

First Posted Date
2016-05-16
Last Posted Date
2024-06-25
Lead Sponsor
Celgene
Target Recruit Count
466
Registration Number
NCT02773030
Locations
🇺🇸

Local Institution - 101, Atlanta, Georgia, United States

🇺🇸

Local Institution - 108, Hackensack, New Jersey, United States

🇺🇸

Local Institution - 115, Boston, Massachusetts, United States

and more 86 locations

Study of Daratumumab in Combination With Dexamethasone in Resistant or Refractory Multiple Myeloma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2015-12-10
Last Posted Date
2021-03-26
Lead Sponsor
University Hospital, Lille
Target Recruit Count
64
Registration Number
NCT02626481
Locations
🇧🇪

AZ ST Jan hematology department, Bruges, Belgium

🇧🇪

Hematologie Laarbeeklaan, Brussel, Belgium

🇧🇪

Jules Bordet Institute, Brussel, Belgium

and more 38 locations

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma

First Posted Date
2015-09-04
Last Posted Date
2020-12-07
Lead Sponsor
Intergroupe Francophone du Myelome
Target Recruit Count
1085
Registration Number
NCT02541383
Locations
🇫🇷

Centre Léon Bérard, Lyon, France

🇧🇪

AZ St Jan Brugge Oostende AV, Brugge, Belgium

🇧🇪

UZ Brussel, Bruxelles, Belgium

and more 103 locations

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

First Posted Date
2015-07-02
Last Posted Date
2023-11-13
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
578
Registration Number
NCT02488759
Locations
🇺🇸

Local Institution - 0003, Atlanta, Georgia, United States

🇧🇪

Local Institution - 0012, Brussels, Belgium

🇺🇸

Local Institution - 0033, Tampa, Florida, United States

and more 37 locations

Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

First Posted Date
2015-06-23
Last Posted Date
2019-01-15
Lead Sponsor
Janssen Research & Development, LLC
Registration Number
NCT02477891

A Study of Atezolizumab (Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Participants With Multiple Myeloma (MM)

First Posted Date
2015-04-30
Last Posted Date
2021-04-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
85
Registration Number
NCT02431208
Locations
🇺🇸

University of Maryland School of Medicine, Baltimore, Maryland, United States

🇺🇸

Mayo Clinic Hospital - Florida, Jacksonville, Florida, United States

🇺🇸

Emory Univ Winship Cancer Inst, Atlanta, Georgia, United States

and more 28 locations

"Monoclonal Antibodies for Treatment of Multiple Myeloma. Emphasis on the CD38 Antibody Daratumumab "

First Posted Date
2015-04-17
Last Posted Date
2017-11-07
Lead Sponsor
Vejle Hospital
Target Recruit Count
4
Registration Number
NCT02419118
Locations
🇩🇰

Department of Hematology Vejle Hospital, Vejle, Denmark

Selinexor and Backbone Treatments of Multiple Myeloma Patients

First Posted Date
2015-01-21
Last Posted Date
2024-05-07
Lead Sponsor
Karyopharm Therapeutics Inc
Target Recruit Count
300
Registration Number
NCT02343042
Locations
🇺🇸

Sarah Cannon-Colorado Blood Cancer Institute, Denver, Colorado, United States

🇺🇸

University of Nebraska Medical Center, Omaha, Nebraska, United States

🇺🇸

Swedish Cancer Institute, Seattle, Washington, United States

and more 21 locations

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma

Phase 2
Completed
Conditions
Interventions
First Posted Date
2014-12-12
Last Posted Date
2024-12-09
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
123
Registration Number
NCT02316106
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