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
-

Study of SubQ Dara With Dose-Attenuated Bortezomib, Lenalidomide, Dexamethasone in Elderly NDMM

First Posted Date
2019-08-12
Last Posted Date
2024-03-28
Lead Sponsor
Larysa Sanchez
Target Recruit Count
18
Registration Number
NCT04052880
Locations
🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

Daratumumab as Maintenance After Peripheral Blood Stem Cell Transplantation From HLA-identical or Haploidentical Family Donor in the Treatment of Refractory or Relapsed Multiple Myeloma: a Phase 2 Trial

Phase 2
Withdrawn
Conditions
Interventions
First Posted Date
2019-07-18
Last Posted Date
2020-03-27
Lead Sponsor
Assistance Publique - Hôpitaux de Paris
Registration Number
NCT04024384
Locations
🇫🇷

Service d'hématologie clinique et thérapie cellulaire, Paris, France

Study of Daratumumab in Multiple Myeloma (MM) Patients in >VGPR/MRD-positive

Phase 2
Conditions
Interventions
First Posted Date
2019-06-20
Last Posted Date
2019-06-20
Lead Sponsor
Azienda Ospedaliera Universitaria Senese
Target Recruit Count
50
Registration Number
NCT03992170
Locations
🇮🇹

Azienda Ospedaliera Universitaria Senese, Siena, Italy

A Study to Determine the Recommended Dose and Regimen and to Evaluate the Safety and Preliminary Efficacy of CC-92480 in Combination With Standard Treatments in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) and Newly Diagnosed Multiple Myeloma (NDMM)

First Posted Date
2019-06-18
Last Posted Date
2024-11-28
Lead Sponsor
Celgene
Target Recruit Count
424
Registration Number
NCT03989414
Locations
🇺🇸

Local Institution - 110, Winston-Salem, North Carolina, United States

🇨🇿

Local Institution - 802, Brno, Czechia

🇨🇿

Local Institution - 801, Ostrava-Poruba, Czechia

and more 46 locations

A Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Participants With Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2019-04-03
Last Posted Date
2024-12-06
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
200
Registration Number
NCT03901963
Locations
🇺🇸

University of Maryland Greenebaum Cancer Center, Baltimore, Maryland, United States

🇺🇸

University of Alabama Birmingham, Birmingham, Alabama, United States

🇺🇸

Arizona Oncology Associates, PC - HAL, Glendale, Arizona, United States

and more 67 locations

Pan Tumor Rollover Study

First Posted Date
2019-04-02
Last Posted Date
2024-11-19
Lead Sponsor
Bristol-Myers Squibb
Target Recruit Count
1500
Registration Number
NCT03899155
Locations
🇧🇷

Local Institution - 0260, Belo Horizonte, Minas Gerais, Brazil

🇨🇳

Harbin Medical University - Cancer Hospital, Harbin, Heilongjiang, China

🇨🇳

Local Institution - 0172, Changsha, Hunan, China

and more 304 locations

STUDY COMPARING TWO STANDARD TREATMENTS IN AUTOLOGOUS STEM CELL TRANSPLANTATION INELIGIBLE POPULATION AFFECTED BY MULTIPLE MYELOMA

First Posted Date
2019-02-04
Last Posted Date
2024-05-08
Lead Sponsor
University of Turin, Italy
Target Recruit Count
450
Registration Number
NCT03829371
Locations
🇮🇹

Dipartimento di Biotecnologie Molecolari e Scienze per la Salute, Torino, TO, Italy

A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent

Phase 4
Completed
Conditions
Interventions
First Posted Date
2018-12-07
Last Posted Date
2022-08-16
Lead Sponsor
Johnson & Johnson Private Limited
Target Recruit Count
150
Registration Number
NCT03768960
Locations
🇮🇳

Basavatarakam Indo-American Hospital, Hyderabad, India

🇮🇳

Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India

🇮🇳

Sparsh Hospitals & Critical Care (Pvt) Ltd, Bhubaneshwar, India

and more 12 locations

Daratumumab, Bortezomib, and Dexamethasone Followed by Daratumumab, Ixazomib, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma

First Posted Date
2018-12-04
Last Posted Date
2024-12-17
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
40
Registration Number
NCT03763162
Locations
🇺🇸

M D Anderson Cancer Center, Houston, Texas, United States

Treatment for Elderly Fit Newly Diagnosed Multiple Myeloma Patients Aged Between 65 and 80 Years

First Posted Date
2018-11-15
Last Posted Date
2022-09-14
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
462
Registration Number
NCT03742297
Locations
🇪🇸

Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

🇪🇸

Hospital Universitario de Cruces, Bilbao, Spain

🇪🇸

Complejo Hospitalario Regional Reina Sofía, Córdoba, Spain

and more 55 locations
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