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.
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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: -

Clinical Trials

A Study of Carfilzomib, Lenalidomide, Dexamethasone and Daratumumab for Patients With Relapsed/Refractory Myeloma With Salvage Autologous Hematopoietic Cell Transplantation

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma

Interventions: Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone
Drug: Daratumumab
Procedure: autologous hematopoietic cell transplantation

First Posted Date: 2018-06-14

Last Posted Date: 2024-03-18

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 41

Registration Number: NCT03556332

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center, New York, New York, United States
🇺🇸
Wake Forest University (Data Collection Only), Winston-Salem, North Carolina, United States
🇺🇸
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale, New York, United States

and more 9 locations

Daratumumab, Carfilzomib, Lenalidomide and Low Dose Dexamethasone (DKRd) in Newly Diagnosed, Multiple Myeloma

Phase 2

Active, not recruiting

Conditions: Multiple Myeloma
Myeloma

Interventions: Drug: Daratumumab
Drug: Carfilzomib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2018-04-18

Last Posted Date: 2024-07-31

Lead Sponsor: University of Chicago

Target Recruit Count: 75

Registration Number: NCT03500445

Locations: 🇺🇸
The University of Chicago, Chicago, Illinois, United States

Short Course Daratumumab in Patients With Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Lenalidomide

First Posted Date: 2018-04-06

Last Posted Date: 2023-11-07

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 10

Registration Number: NCT03490344

Locations: 🇺🇸
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
🇺🇸
Memoral Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 4 locations

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM

Phase 1

Terminated

Conditions: Multiple Myeloma

Interventions: Drug: Melphalan flufenamide (Melflufen)
Drug: Dexamethasone
Drug: Bortezomib
Drug: Daratumumab

First Posted Date: 2018-03-29

Last Posted Date: 2022-12-19

Lead Sponsor: Oncopeptides AB

Target Recruit Count: 56

Registration Number: NCT03481556

Locations: 🇨🇿
Fakultní nemocnice Hradec Králové, Hradec Králové, Czechia
🇨🇿
Fakultní nemocnice Ostrava, Ostrava, Czechia
🇫🇷
Hôpital Morvan, Brest, France

and more 13 locations

Effects of Daratumumab Monotherapy on Bone Parameters in Patients With Relapsed and /or Refractory Multiple Myeloma

Phase 2

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab

First Posted Date: 2018-03-23

Last Posted Date: 2018-03-23

Lead Sponsor: Hellenic Society of Hematology

Target Recruit Count: 57

Registration Number: NCT03475628

Locations: 🇬🇷
General Hospital of Athens "Alexandra", Athens, Attica, Greece

Daratumumab in Treating Patients with Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer

Early Phase 1

Active, not recruiting

Conditions: Bladder Urothelial Carcinoma
Clear Cell Renal Cell Carcinoma
Malignant Urinary System Neoplasm
Metastatic Kidney Carcinoma
Stage IV Renal Cell Cancer AJCC V8

Interventions: Procedure: Biopsy
Biological: Daratumumab
Other: Laboratory Biomarker Analysis
Procedure: Metastasectomy
Procedure: Nephrectomy

First Posted Date: 2018-03-22

Last Posted Date: 2024-10-24

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 17

Registration Number: NCT03473730

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

A Study of Ixazomib+Daratumumab+Dexamethasone (IDd) in Relapsed and/or Refractory Multiple Myeloma (RRMM)

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Ixazomib
Drug: Daratumumab
Drug: Dexamethasone

First Posted Date: 2018-02-20

Last Posted Date: 2024-07-03

Lead Sponsor: Takeda

Target Recruit Count: 61

Registration Number: NCT03439293

Locations: 🇺🇸
Colorado Blood Cancer Institute, Denver, Colorado, United States
🇺🇸
Pacific Cancer Medical Center, Anaheim, California, United States
🇺🇸
Research Medical Center - Kansas City, Kansas City, Missouri, United States

and more 25 locations

A Study to Evaluate Subcutaneous Daratumumab in Combination With Standard Multiple Myeloma Treatment Regimens

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: Bortezomib
Drug: Lenalidomide
Drug: Melphalan
Drug: Carfilzomib
Drug: Dexamethasone
Drug: Prednisone

First Posted Date: 2018-01-26

Last Posted Date: 2024-05-24

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 265

Registration Number: NCT03412565

Locations: 🇺🇸
Cancer Center of Central Connecticut - Southington, Southington, Connecticut, United States
🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
🇺🇸
Avera Medical Group - Oncology & Hematology, Sioux Falls, South Dakota, United States

and more 60 locations

A Study to Evaluate the Efficacy and Safety of Daratumumab in Pediatric and Young Adult Participants Greater Than or Equal to (>=)1 and Less Than or Equal to (<=) 30 Years of Age With Relapsed/Refractory Precursor B-cell or T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

Phase 2

Completed

Conditions: Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions: Drug: Daratumumab
Drug: Vincristine
Drug: Prednisone
Drug: Doxorubicin
Biological: Peg-asparaginase
Drug: Cyclophosphamide
Drug: Cytarabine
Drug: 6-mercaptopurine
Drug: Methotrexate

First Posted Date: 2017-12-27

Last Posted Date: 2023-12-21

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 47

Registration Number: NCT03384654

Locations: 🇺🇸
Children'S Healthcare Of Atlanta/Emory Univ. Dept. Of Pediatrics, Atlanta, Georgia, United States
🇺🇸
Newark Beth Israel Medical Center, Newark, New Jersey, United States
🇺🇸
UT Southwestern Medical Center, Dallas, Texas, United States

and more 50 locations

A Study of JNJ-63723283, an Anti-programmed Death-1 Monoclonal Antibody, Administered in Combination With Daratumumab, Compared With Daratumumab Alone in Participants With Relapsed or Refractory Multiple Myeloma

Phase 2

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Daratumumab
Drug: JNJ-63723283

First Posted Date: 2017-11-30

Last Posted Date: 2022-12-05

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 10

Registration Number: NCT03357952

Locations: 🇧🇪
Algemeen Ziekenhuis Klina, Brasschaat, Belgium
🇮🇱
Hadassah Medical Center, Jerusalem, Israel
🇧🇪
UZBrussel, Brussel, Belgium

and more 10 locations

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