Belantamab mafodotin ( DrugBank: Belantamab mafodotin )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
28全身性アミロイドーシス7

28. 全身性アミロイドーシス


臨床試験数 : 267 薬物数 : 241 - (DrugBank : 77) / 標的遺伝子数 : 68 - 標的パスウェイ数 : 180
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05145816
(ClinicalTrials.gov)
August 1, 202323/11/2021Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL AmyloidosisA Dose-Finding and Proof-of-Concept Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL AmyloidosisAL Amyloidosis;AmyloidosisDrug: Belantamab mafodotin 2.5 mg/kg (6 weeks);Drug: Belantamab mafodotin 2.5 mg/kg (4 weeks);Drug: Belantamab mafodotin 2.5 mg/kg (8 weeks);Drug: Belantamab mafodotin 1.9 mg/kg (8 weeks);Drug: Belantamab mafodotin 1.9mg/kg or 2.5mg/kg every 4 weeks, 6 weeks or 8 weeks as determined by Part 1 recommended dosagesUniversity of Texas Southwestern Medical CenterGlaxoSmithKlineNot yet recruiting18 YearsN/AAll37Phase 1/Phase 2United States
2EUCTR2020-004001-32-NL
(EUCTR)
24/06/202129/01/2021Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosisA phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis relapsed or refractory AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: belantamab mafodotin
Product Code: GSK2857916
INN or Proposed INN: belantamab mafodotin
European Myeloma Network – EMNNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;Greece;Germany;Netherlands;United Kingdom;Italy
3EUCTR2020-004001-32-IT
(EUCTR)
03/05/202102/08/2021Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosisA phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis. - EMN27 Relapsed or refractory AL amyloidosis.
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Belantamab mafodotin
Product Code: [GSK2857916]
INN or Proposed INN: belantamab mafodotin
STICHTING EUROPEAN MYELOMA NETWORKNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;Greece;Netherlands;Germany;United Kingdom;Italy
4EUCTR2020-004001-32-DE
(EUCTR)
27/04/202104/12/2020Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosisA phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis relapsed or refractory AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: belantamab mafodotin
Product Code: GSK2857916
INN or Proposed INN: belantamab mafodotin
European Myeloma Network – EMNNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;Greece;Netherlands;Germany;United Kingdom;Italy
5NCT04617925
(ClinicalTrials.gov)
February 26, 202120/10/2020A Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL AmyloidosisA Phase 2 Study of Belantamab Mafodotin in Patients With Relapsed or Refractory AL AmyloidosisAL AmyloidosisDrug: Belantamab mafodotinEuropean Myeloma NetworkGlaxoSmithKlineRecruiting18 YearsN/AAll35Phase 2France;Germany;Greece;Italy;Netherlands;United Kingdom
6EUCTR2020-004001-32-FR
(EUCTR)
29/01/202103/12/2020Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosisA phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis relapsed or refractory AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: belantamab mafodotin
Product Code: GSK2857916
INN or Proposed INN: belantamab mafodotin
European Myeloma Network – EMNNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;Greece;Netherlands;Germany;United Kingdom;Italy
7EUCTR2020-004001-32-GR
(EUCTR)
15/01/202104/12/2020Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosisA phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis relapsed or refractory AL amyloidosis
MedDRA version: 20.0;Level: PT;Classification code 10002022;Term: Amyloidosis;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: belantamab mafodotin
Product Code: GSK2857916
INN or Proposed INN: belantamab mafodotin
European Myeloma Network – EMNNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2France;Greece;Germany;Netherlands;United Kingdom;Italy