Clinical trial • Phase I • Oncology

Belantamab mafodotin for Relapsed/Refractory multiple myeloma

Phase I trial of Belantamab mafodotin for Relapsed/Refractory multiple myeloma. 27 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/Refractory multiple myeloma
Trial Stage
Phase I
Drug Modality
ADC

Key dates

Initial CTIS Submission Date
25-10-2023
First CTIS Authorization Date
26-01-2024

Trial design

Phase I trial across 2 sites in Greece.

Target Sample Size
27

Eligibility

Recruits 27 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent/assent handling provided in source..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent/assent handling provided in source.

Recruitment

Planned Sample Size
27
Recruitment Window Months
57

Geography

Total Number Of Sites
2
Total Number Of Participants
27

Greece

Earliest CTIS Part Ii Submission Date
01-11-2023
Latest Decision Or Authorization Date
22-01-2026
Processing Time Days
813
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Evangelismos S.A.
Department Name
Hematology Clinic
Principal Investigator Name
Sosana Dempimpasi
Principal Investigator Email
sodeli@yahoo.com
Contact Person Name
Sosana Dempimpasi
Contact Person Email
sodeli@yahoo.com
Site Name
Alexandra Hospital
Department Name
Department of Clinical Therapeutics
Principal Investigator Name
Meletios - Athanasios Dimopoulos
Principal Investigator Email
mdimop@med.uoa.gr
Contact Person Name
Meletios - Athanasios Dimopoulos
Contact Person Email
mdimop@med.uoa.gr

Sponsor

Primary sponsor

Full Name
Glaxosmithkline Research & Development Limited
Organisation Type
Pharmaceutical company
Country Of Registered Address
United Kingdom

Investigational products

Investigational Product Name
Belantamab mafodotin
Active Substance
Belantamab mafodotin
Modality
ADC

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