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
- Contact Person Email
- marc.raab@med.uni-heidelberg.de
- 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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