Melphalan flufenamide
- Generic Name
- Melphalan flufenamide
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C24H30Cl2FN3O3
- CAS Number
- 380449-51-4
- Unique Ingredient Identifier
- F70C5K4786
- Background
Melphalan flufenamide, also known as melflufen or J1, is a prodrug of melphalan. Melphalan flufenamide is more readily uptaken by cells than melphalan, and is cleaved to the active metabolite by aminopeptidases. In vitro models show that melphalan is 10 to hundreds of times more potent than melphalan. The increased potency makes melphalan flufenamide a treat...
- Indication
Melphalan flufenamide is indicated in combination with dexamethasone to treat adults with relapsed or refractory multiple myeloma who have received ≥4 therapies and are refractory to at least one proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody. The FDA has withdrawn the drug from the market for this indication following phase ...
- Associated Conditions
- Relapsed/Refractory Multiple Myeloma (RRMM)
- Associated Therapies
- -
Melflufen for Elderly Patients With Relapsed Myeloma
- Conditions
- Interventions
- First Posted Date
- 2024-11-12
- Last Posted Date
- 2024-11-13
- Lead Sponsor
- Fondazione EMN Italy Onlus
- Target Recruit Count
- 30
- Registration Number
- NCT06682637
- Locations
- 🇮🇹
A.O.U. delle Marche, Ancona, Italy
🇮🇹Ospedale Nuovo di Legnano, Legnano, Italy
🇮🇹Ospedale Niguarda, Milano, Italy
Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma
- Conditions
- Interventions
- First Posted Date
- 2020-12-02
- Last Posted Date
- 2023-06-08
- Lead Sponsor
- Oncopeptides AB
- Target Recruit Count
- 54
- Registration Number
- NCT04649060
- Locations
- 🇵🇱
Independent Public Healthcare Facility University Hospital in Krakow, Teaching Unit of the Hematology Department, Kraków, Poland
🇧🇬Specialized Hospital for Active Treatment of Hematological Diseases, Clinical Hematology Clinic, Sofia, Bulgaria
🇨🇿University Hospital Hradec Kralove, 4th Internal Clinic of Hematology, Kralovice, Czechia
Expanded Access Program for Melphalan Flufenamide (Melflufen) in Triple Class Refractory Multiple Myeloma
- First Posted Date
- 2020-09-01
- Last Posted Date
- 2021-03-18
- Lead Sponsor
- Oncopeptides AB
- Registration Number
- NCT04534322
- Locations
- 🇺🇸
University of Illinois Cancer Center, Chicago, Illinois, United States
🇺🇸Gabrail Cancer Center, Canton, Ohio, United States
🇺🇸Texas Oncology, Dallas, Texas, United States
PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function
- Conditions
- Interventions
- First Posted Date
- 2018-08-21
- Last Posted Date
- 2023-03-10
- Lead Sponsor
- Oncopeptides AB
- Target Recruit Count
- 35
- Registration Number
- NCT03639610
- Locations
- 🇨🇿
University Hospital Olomouc, Clinic of Hemato-Oncology, Olomouc, Czechia
🇬🇷University General Hospital of Patras, Patra, Greece
🇬🇷General Hospital of Athens Alexandra, Therapeutic Clinic, Athens, Greece
A Study of Melphalan Flufenamide (Melflufen)-Dex or Pomalidomide-dex for RRMM Patients Refractory to Lenalidomide
- Conditions
- Interventions
- First Posted Date
- 2017-05-12
- Last Posted Date
- 2024-01-30
- Lead Sponsor
- Oncopeptides AB
- Target Recruit Count
- 495
- Registration Number
- NCT03151811
- Locations
- 🇨🇿
CZ-01, Ostrava, Czechia
🇺🇸US-19, Plantation, Florida, United States
🇺🇸US01, Fresno, California, United States
Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients
- Conditions
- Interventions
- First Posted Date
- 2013-07-12
- Last Posted Date
- 2020-10-23
- Lead Sponsor
- Oncopeptides AB
- Target Recruit Count
- 75
- Registration Number
- NCT01897714
- Locations
- 🇮🇹
Turin Hospital Myeloma Unit, Turin, Italy
🇩🇰Vejle Hospital, Vejle, Denmark
🇸🇪Sahlgrenska Hospital, Gothenburg, Sweden
Drug Development Updates
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