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

MC210808 Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma

Phase 1

Recruiting

Conditions: Multiple Myeloma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Chest Radiography
Procedure: Computed Tomography
Biological: Daratumumab
Drug: Dexamethasone
Drug: Lenalidomide
Procedure: Low Dose Computed Tomography of the Whole Body
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Drug: Venetoclax
Procedure: X-Ray Imaging
Other: Questionnaire Administration

First Posted Date: 2023-09-18

Last Posted Date: 2025-05-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 100

Registration Number: NCT06042725

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

Comparing Dara-VCD Chemotherapy Plus Stem Cell Transplant to Dara-VCD Chemotherapy Alone for People Who Have Newly Diagnosed AL Amyloidosis

Phase 3

Recruiting

Conditions: AL Amyloidosis

Interventions: Procedure: Biospecimen Collection
Procedure: Autologous Hematopoietic Stem Cell Transplantation
Procedure: Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Drug: Daratumumab and Hyaluronidase-fihj
Drug: Bortezomib
Procedure: Computed Tomography
Drug: Melphalan
Procedure: Stem Cell Isolation
Drug: Cyclophosphamide
Drug: Dexamethasone
Procedure: Echocardiography
Other: Survey Administration
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography

First Posted Date: 2023-09-05

Last Posted Date: 2024-07-08

Lead Sponsor: SWOG Cancer Research Network

Target Recruit Count: 338

Registration Number: NCT06022939

Locations: 🇺🇸
Boston Medical Center, Boston, Massachusetts, United States
🇺🇸
Washington University School of Medicine, Saint Louis, Missouri, United States
🇺🇸
Siteman Cancer Center-South County, Saint Louis, Missouri, United States

and more 32 locations

Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer

Phase 2

Recruiting

Conditions: Pancreatic Ductal Adenocarcinoma
Refractory Non-Small Cell Lung Cancer

Interventions: Drug: Daratumumab
Biological: KRAS vaccine
Drug: Nivolumab

First Posted Date: 2023-08-29

Last Posted Date: 2024-02-05

Lead Sponsor: Georgetown University

Target Recruit Count: 54

Registration Number: NCT06015724

Locations: 🇺🇸
Georgetown Lombardi Comprehensive Cancer Center, Washington, District of Columbia, United States

A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: BCD-264
Drug: Darzalex

First Posted Date: 2023-08-03

Last Posted Date: 2023-11-18

Lead Sponsor: Biocad

Target Recruit Count: 146

Registration Number: NCT05974969

Locations: 🇷🇺
Institute of the Human Brain n. a. N.P. Bekhtereva Russian Academy of Sciences, Saint Petersburg, Russian Federation
🇷🇺
Smorodintsev Research Institute of Influenza, Saint Petersburg, Russian Federation
🇷🇺
X7 Clinical Research, Saint Petersburg, Russian Federation

The Safety and Efficacy of CD38 Monoclonal Antibody Monotherapy for CaAMR in Renal Transplantation

Not Applicable

Recruiting

Conditions: Antibody-mediated Rejection
Kidney Tranplant

Interventions: Drug: Daratumumab

First Posted Date: 2023-06-22

Last Posted Date: 2023-09-14

Lead Sponsor: First Affiliated Hospital of Zhejiang University

Target Recruit Count: 15

Registration Number: NCT05913596

Locations: 🇨🇳
79# Qingchun Road, Hangzhou, Zhejiang, China

Daratumumab for Relapsed/Refractory Primary Effusion Lymphoma

Phase 2

Recruiting

Conditions: Lymphoma, Primary Effusion

Interventions: Drug: Daratumumab SC

First Posted Date: 2023-06-18

Last Posted Date: 2025-03-11

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 28

Registration Number: NCT05907759

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

Daratumumab Maintenance Therapy for Improving Survival in Patients With Light Chain Amyloidosis, EMILIA Trial

Phase 2

Recruiting

Conditions: AL Amyloidosis

Interventions: Procedure: Bone Marrow Aspiration
Biological: Daratumumab
Procedure: Echocardiography
Other: Questionnaire Administration
Procedure: X-Ray Imaging
Procedure: Biospecimen Collection

First Posted Date: 2023-06-12

Last Posted Date: 2025-04-24

Lead Sponsor: Mayo Clinic

Target Recruit Count: 96

Registration Number: NCT05898646

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients with Relapsed/Refractory Multiple Myeloma

Phase 2

Recruiting

Conditions: Refractory Multiple Myeloma
Relapsed Multiple Myeloma

Interventions: Drug: Iberdomide
Drug: Carfilzomib
Drug: Daratumumab
Drug: Dexamethasone
Drug: Acetaminophen
Drug: Diphenhydramine
Drug: Montelukast

First Posted Date: 2023-06-09

Last Posted Date: 2025-03-11

Lead Sponsor: Benjamin T Diamond, MD

Target Recruit Count: 30

Registration Number: NCT05896228

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

ITI Using SCT800 Alone or Combining Daratumumab in Hemophilia A Adolescents and Adults With High Titer Inhibitor

Phase 4

Recruiting

Conditions: Hemophilia A With Inhibitor

Interventions: Drug: SCT800 and Daratumumab
Drug: SCT800

First Posted Date: 2023-06-05

Last Posted Date: 2025-02-24

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

Target Recruit Count: 50

Registration Number: NCT05888870

Locations: 🇨🇳
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China

An Exploratory Study of Cluster of Differentiation 38 (CD38) Monoclonal Antibody Combined Corticosteroid in Acquired Hemophilia A

Phase 4

Recruiting

Conditions: Acquired Hemophilia

Interventions: Drug: Daratumumab and corticosteroid treatment

First Posted Date: 2023-05-09

Last Posted Date: 2025-02-21

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

Target Recruit Count: 10

Registration Number: NCT05849740

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

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