Clinical trial • Phase I/II • Haematology

Belantamab mafodotin for Multiple myeloma|Relapsed/refractory multiple myeloma

Phase I/II trial of Belantamab mafodotin for Multiple myeloma|Relapsed/refractory multiple myeloma. 43 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Multiple myeloma|Relapsed/refractory multiple myeloma
Trial Stage
Phase I/II
Drug Modality
ADC|Small molecule

Key dates

Initial CTIS Submission Date
27-09-2024
First CTIS Authorization Date
18-10-2024

Trial design

Phase I/II trial across 7 sites in Germany.

Target Sample Size
43

Eligibility

Recruits 43 Vulnerable population not selected (isVulnerablePopulationSelected=false); no additional information on consent or assent provided in the record..

Vulnerable Population
Vulnerable population not selected (isVulnerablePopulationSelected=false); no additional information on consent or assent provided in the record.

Recruitment

Planned Sample Size
43
Recruitment Window Months
45

Geography

Total Number Of Sites
7
Total Number Of Participants
43

Germany

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
29-12-2025
Processing Time Days
444
Number Of Sites
7
Number Of Participants
43

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Innere Medizin III
Contact Person Name
Miriam Kull
Contact Person Email
miriam.kull@uniklinik-ulm.de
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
Klinik für Hämatologie und Onkologie
Contact Person Name
Niklas Gebauer
Site Name
Charite Research Organisation GmbH
Department Name
Medizinische Klinik, Haematologie/Onkologie, Tumorimmunologie
Contact Person Name
Stephan Bohl
Contact Person Email
stephan.bohl@charite.de
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Klinik und Poliklinik für Innere Medizin C
Contact Person Name
William Hermann Krüger
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Klinik für Hämatologie, Onkologie, Rheumatologie
Contact Person Name
Elias Karl Mai
Site Name
Klinikum Chemnitz gGmbH
Department Name
Klinik für Innere Medizin III
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
II. Medical Clinic & Polyclinic, Oncology, Heamatology, BMT, Pneumology
Contact Person Name
Katja Weisel
Contact Person Email
k.weisel@uke.de

Sponsor

Primary sponsor

Full Name
University Medical Center Hamburg-Eppendorf
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Germany

Investigational products

Investigational Product Name
Belantamab Mafodotin
Active Substance
Belantamab mafodotin
Modality
ADC
Investigational Product Name
Venetoclax
Active Substance
Venetoclax
Modality
Small molecule
Combination Treatment
Yes

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