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

A Study Comparing Pharmacokinetic and Safety of QL2109 and DARZALEX FASPRO® in Healthy Adults

Phase 1

Recruiting

Conditions: Tumor

Interventions: Drug: DARZALEX FASPRO®
Drug: QL2109

First Posted Date: 2024-04-17

Last Posted Date: 2025-02-11

Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Target Recruit Count: 228

Registration Number: NCT06371534

Locations: 🇨🇳
The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China

Sickle Cell Disease Transplant Using a Nonmyeloablative Approach for Patients With Anti-donor Red Cell AntibodY

Phase 2

Recruiting

Conditions: Sickle Cell Disease

Interventions: Drug: Daratumumab
Drug: Alemtuzumab
Drug: Sirolimus
Radiation: Total Body Irradiation

First Posted Date: 2024-04-10

Last Posted Date: 2024-06-20

Lead Sponsor: Children's National Research Institute

Target Recruit Count: 12

Registration Number: NCT06358638

Locations: 🇺🇸
Children's National Hospital, Washington, District of Columbia, United States

Minimal Residual Disease-based Strategy with T-Cell Redirector After Treatment with Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone (D-VRd) in Newly Diagnosed Multiple Myeloma

Phase 2

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Teclistamab
Drug: Lenalidomide
Drug: Talquetamab
Drug: Bortezomib
Drug: Daratumumab
Drug: Dexamethasone

First Posted Date: 2024-04-08

Last Posted Date: 2025-03-13

Lead Sponsor: Nantes University Hospital

Target Recruit Count: 103

Registration Number: NCT06353022

Locations: 🇫🇷
CHU Poitiers, Poitiers, France
🇫🇷
CH de la Côte Basque, Bayonne, France
🇫🇷
CHU Caen, Caen, France

and more 17 locations

Dara-RVd Induction for Newly Diagnosed Multiple Myeloma With Autologous Stem Cell Transplantation

Phase 2

Suspended

Conditions: Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Autologous Stem Cell Transplantation

Interventions: Biological: Daratumumab
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone

First Posted Date: 2024-04-04

Last Posted Date: 2025-05-20

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 39

Registration Number: NCT06348147

Locations: 🇺🇸
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States

Combination of Daratumumab and BD Regimen and Dapagliflozin in the Treatment of M-protein Related Cardiac Disease

Not yet recruiting

Conditions: M-protein Related Cardiac Disease

Interventions: Drug: Daratumumab + Bortezomib + Dexamethasone + Dapagliflozin

First Posted Date: 2024-03-07

Last Posted Date: 2024-03-07

Lead Sponsor: Beijing Chao Yang Hospital

Target Recruit Count: 40

Registration Number: NCT06297681

A Study of the Efficacy and Safety of Monotherapy With BCD-264 and Darzalex in Subjects With Relapsed and Refractory Multiple Myeloma

Phase 3

Recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Darzalex
Drug: BCD-264

First Posted Date: 2024-03-06

Last Posted Date: 2024-03-06

Lead Sponsor: Biocad

Target Recruit Count: 252

Registration Number: NCT06296121

Locations: 🇷🇺
Russian Research Institute of Hematology and Transfusiology of the Federal Medical and Biological Agency, Saint Petersburg, Russian Federation
🇷🇺
Chelyabinsk Regional Clinical Hospital, Chelyabinsk, Russian Federation
🇷🇺
Kuzbass Regional Clinical Hospital named after S.V. Belyaev, Kemerovo, Russian Federation

and more 11 locations

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome

Phase 1

Recruiting

Conditions: Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia

Interventions: Biological: Actinium Ac 225-DOTA-Daratumumab
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Biological: Daratumumab
Procedure: Echocardiography
Drug: Fludarabine
Procedure: Hematopoietic Cell Transplantation
Biological: Indium In 111-DOTA-Daratumumab
Drug: Melphalan
Procedure: Multigated Acquisition Scan
Procedure: Radionuclide Imaging
Procedure: Single Photon Emission Computed Tomography
Drug: Sirolimus
Drug: Tacrolimus
Radiation: Total Marrow and Lymphoid Irradiation

First Posted Date: 2024-03-01

Last Posted Date: 2025-02-18

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 15

Registration Number: NCT06287944

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States

Daratumumab in VHR T-ALL Treated According to the ALL National Treatment Program

Phase 2

Recruiting

Conditions: T-Lymphocytic Leukemia, Acute

Interventions: Drug: Daratumumab plus chemotherapy according to the national treatment program

First Posted Date: 2024-02-12

Last Posted Date: 2024-11-08

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 31

Registration Number: NCT06253637

Locations: 🇮🇹
Ematologia AOU Careggi, Firenze, Italy
🇮🇹
Ematologia P.O. Vito Fazzi - Lecce, Lecce, Italy
🇮🇹
Ematologia AOU Policlinico Umberto I, Roma, Italy

A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Phase 3

Withdrawn

Conditions: Multiple Myeloma

Interventions: Drug: Alnuctamab
Drug: Pomalidomide
Drug: Daratumumab
Drug: Elotuzumab
Drug: Carfilzomib
Drug: Dexamethasone

First Posted Date: 2024-01-31

Last Posted Date: 2024-05-31

Lead Sponsor: Celgene

Registration Number: NCT06232707

Locations: 🇺🇸
Local Institution - 0088, Los Angeles, California, United States
🇺🇸
Local Institution - 0324, Baltimore, Maryland, United States
🇦🇺
Local Institution - 0022, Waratah, New South Wales, Australia

and more 167 locations

Optimize First-line Treatment for AL Amyloidosis With t (11; 14)

Not Applicable

Recruiting

Conditions: AL Amyloidosis
Amyloidosis; Systemic

Interventions: Drug: Daratumumab
Drug: Bortezomib
Drug: Dexamethasone
Drug: Venetoclax

First Posted Date: 2024-01-05

Last Posted Date: 2024-02-06

Lead Sponsor: Jin Lu, MD

Target Recruit Count: 41

Registration Number: NCT06192979

Locations: 🇨🇳
Peking University People's Hospital, Beijing, Beijing, China

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy