Clinical trial • Phase I • Oncology

BMS-986453 for Relapsed/refractory multiple myeloma

Phase I trial of BMS-986453 for Relapsed/refractory multiple myeloma. 100 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/refractory multiple myeloma
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
06-06-2024
First CTIS Authorization Date
19-11-2024

Trial design

Phase I trial across 7 sites in Germany, Spain, France.

Target Sample Size
100

Eligibility

Recruits 100 Vulnerable population not selected; no specific consent or assent handling mentioned..

Vulnerable Population
Vulnerable population not selected; no specific consent or assent handling mentioned.

Recruitment

Planned Sample Size
100
Recruitment Window Months
36

Geography

Total Number Of Sites
7
Total Number Of Participants
50

Germany

Earliest CTIS Part Ii Submission Date
18-09-2024
Latest Decision Or Authorization Date
12-08-2025
Processing Time Days
328
Number Of Sites
3
Number Of Participants
24

Sites

Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Med. Klinik und Poliklinik II ZIM Haus A4
Principal Investigator Name
Herrmann Einsele
Principal Investigator Email
einsele_h@ukw.de
Contact Person Name
Herrmann Einsele
Contact Person Email
einsele_h@ukw.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Innere Medizin V
Principal Investigator Name
Marc-Steffen Raab
Principal Investigator Email
marc.raab@med.uni-heidelberg.de
Contact Person Name
Marc-Steffen Raab
Site Name
University Hospital Cologne AöR
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Christoph Scheid
Principal Investigator Email
c.scheid@uni-koeln.de
Contact Person Name
Christoph Scheid
Contact Person Email
c.scheid@uni-koeln.de

Spain

Earliest CTIS Part Ii Submission Date
02-09-2024
Latest Decision Or Authorization Date
12-08-2025
Processing Time Days
344
Number Of Sites
3
Number Of Participants
18

Sites

Site Name
Hospital Universitario De Salamanca
Department Name
Hematologia
Principal Investigator Name
Maria Victoria Mateos
Principal Investigator Email
mvmateos@usal.es
Contact Person Name
Maria Victoria Mateos
Contact Person Email
mvmateos@usal.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Hematologia
Principal Investigator Name
Paula Rodriguez Otero
Principal Investigator Email
paurodriguez@unav.es
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Hematologia
Principal Investigator Name
Paula Rodriguez Otero
Principal Investigator Email
paurodriguez@unav.es
Contact Person Name
Paula Rodriguez Otero
Contact Person Email
paurodriguez@unav.es

France

Earliest CTIS Part Ii Submission Date
12-09-2024
Latest Decision Or Authorization Date
18-08-2025
Processing Time Days
340
Number Of Sites
1
Number Of Participants
8

Sites

Site Name
Hopital Saint Louis
Department Name
Service d'immuno-hematologie
Principal Investigator Name
Bertrand ARNULF
Principal Investigator Email
bertrand.arnulf@sls.aphp.fr
Contact Person Name
Bertrand ARNULF
Contact Person Email
bertrand.arnulf@sls.aphp.fr

Sponsor

Primary sponsor

Full Name
Celgene Corp.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
BMS-986453

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