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, Ixazomib, and Dexamethasone in AL Amyloidosis

Phase 1

Active, not recruiting

Conditions: Newly Diagnosed Primary Amyloidosis
Refractory Primary Amyloidosis
Recurrent Primary Amyloidosis

Interventions: Biological: Daratumumab
Drug: Dexamethasone
Drug: Ixazomib

First Posted Date: 2017-09-14

Last Posted Date: 2025-05-01

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 21

Registration Number: NCT03283917

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

A Study to Compare Daratumumab, Bortezomib, and Dexamethasone (DVd) vs Bortezomib and Dexamethasone (Vd) in Chinese Participants With Relapsed or Refractory Multiple Myeloma

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Velcade
Drug: Dexamethasone

First Posted Date: 2017-08-01

Last Posted Date: 2024-05-29

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 213

Registration Number: NCT03234972

Locations: 🇨🇳
National Taiwan University Hospital, Taipei, Taiwan
🇨🇳
Peking Union Medical College Hospital, Beijing, China
🇨🇳
Peking University People s Hospital, Beijing, China

and more 24 locations

Phase II Study of the CD38 Antibody Daratumumab in Patients With High-Risk MGUS and Low-Risk Smoldering Multiple Myeloma

Phase 2

Active, not recruiting

Conditions: Smoldering Multiple Myeloma
Monoclonal Gammopathy

Interventions: Drug: Daratumumab

First Posted Date: 2017-08-01

Last Posted Date: 2025-03-05

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 42

Registration Number: NCT03236428

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Pacific Cancer Care, Monterey, California, United States
🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

and more 3 locations

A Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Participants With Previously Untreated Multiple Myeloma Who Are Ineligible for High-Dose Therapy (Asia Pacific Region)

Phase 3

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Velcade
Drug: Melphalan
Drug: Prednisone
Drug: Daratumumab

First Posted Date: 2017-07-14

Last Posted Date: 2024-04-25

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 220

Registration Number: NCT03217812

Locations: 🇭🇰
Queen Mary Hospital University of Hong Kong, Hong Kong, Hong Kong
🇰🇷
Ulsan University Hospital, Ulsan, Korea, Republic of
🇲🇾
Hospital Ampang, Ampang, Malaysia

and more 40 locations

Trial Evaluating the Efficacy and Safety of Daratumumab in Subjects With Relapsed/Refractory B-cell or T-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Phase 2

Withdrawn

Conditions: Malignant Neoplasms Stated as Primary Lymphoid Haematopoietic

Interventions: Drug: Daratumumab

First Posted Date: 2017-07-02

Last Posted Date: 2018-07-26

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT03207542

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis

Phase 3

Completed

Conditions: Amyloidosis

Interventions: Drug: Cyclophosphamide
Drug: Daratumumab
Drug: Bortezomib
Drug: Dexamethasone, 40 mg

First Posted Date: 2017-06-28

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 416

Registration Number: NCT03201965

Locations: 🇫🇷
CHU De Poitiers, Poitiers, France
🇫🇷
Institut Paoli Calmettes, Marseille, France
🇫🇷
Chu Hotel Dieu, Nantes cedex 01, France

and more 136 locations

MUK Nine b: OPTIMUM Treatment Protocol

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Cyclophosphamide
Drug: Bortezomib
Drug: Lenalidomide
Drug: Daratumumab
Drug: Dexamethasone
Drug: Melphalan
Drug: Filgrastim

First Posted Date: 2017-06-15

Last Posted Date: 2024-05-14

Lead Sponsor: University of Leeds

Target Recruit Count: 95

Registration Number: NCT03188172

Locations: 🇬🇧
Bristol Haematology & Oncology Centre, Bristol, United Kingdom
🇬🇧
Queen Elizabeth Hospital, Birmingham, United Kingdom
🇬🇧
Birmingham Heartlands Hospital, Birmingham, United Kingdom

and more 18 locations

A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia

Phase 2

Completed

Conditions: Waldenström Macroglobulinemia

Interventions: Drug: Daratumumab

First Posted Date: 2017-06-14

Last Posted Date: 2022-11-23

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 13

Registration Number: NCT03187262

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
University of Washington, Seattle, Washington, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

and more 2 locations

Comparison of Pomalidomide and Dexamethasone With or Without Daratumumab in Subjects With Relapsed or Refractory Multiple Myeloma Previously Treated With Lenalidomide and a Proteasome InhibitorDaratumumab/Pomalidomide/Dexamethasone vs Pomalidomide/Dexamethasone

Phase 3

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Pomalidomide
Drug: Dexamethasone

First Posted Date: 2017-06-08

Last Posted Date: 2022-05-11

Lead Sponsor: Stichting European Myeloma Network

Target Recruit Count: 304

Registration Number: NCT03180736

Locations: 🇮🇹
Ancona, Ancona, Italy
🇮🇹
Brescia, Brescia, Italy
🇨🇿
Praha 2, Praha, Czechia

and more 37 locations

Study of Carfilzomib, Daratumumab and Dexamethasone for Patients With Relapsed and/or Refractory Multiple Myeloma.

Phase 3

Completed

Conditions: Relapsed Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Drug: Dexamethasone
Drug: Carfilzomib
Drug: Daratumumab

First Posted Date: 2017-05-18

Last Posted Date: 2025-05-09

Lead Sponsor: Amgen

Target Recruit Count: 466

Registration Number: NCT03158688

Locations: 🇺🇸
Hackensack University Medical Center, Hackensack, New Jersey, United States
🇺🇸
Baylor Charles A Sammons Cancer Center at Dallas, Dallas, Texas, United States
🇨🇦
Princess Margaret Cancer Centre, Toronto, Ontario, Canada

and more 110 locations

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