Clinical trial • Phase III • Oncology

XmAb24306 for Relapsed/Refractory Multiple Myeloma|Multiple myeloma

Phase III trial of XmAb24306 for Relapsed/Refractory Multiple Myeloma|Multiple myeloma. 39 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Relapsed/Refractory Multiple Myeloma|Multiple myeloma
Trial Stage
Phase III

Key dates

Initial CTIS Submission Date
05-06-2024
First CTIS Authorization Date
02-07-2024

Trial design

Phase III trial across 4 sites in Denmark, Greece, Spain and others.

Target Sample Size
39

Eligibility

Recruits 39 Vulnerable population selected; no details on consent or assent handling provided in the source data..

Vulnerable Population
Vulnerable population selected; no details on consent or assent handling provided in the source data.

Recruitment

Planned Sample Size
39
Recruitment Window Months
43

Geography

Total Number Of Sites
4
Total Number Of Participants
43

Denmark

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
23-06-2025
Processing Time Days
364
Number Of Sites
1
Number Of Participants
6

Sites

Site Name
Lillebaelt Hospital
Department Name
Department of Hematology
Principal Investigator Name
Katrine Fladeland
Principal Investigator Email
Katrine.Fladeland.Iversen@rsyd.dk
Contact Person Name
Katrine Fladeland
Number Of Participants
6

Greece

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
02-03-2026
Processing Time Days
616
Number Of Sites
1
Number Of Participants
8

Sites

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
Number Of Participants
8

Spain

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
07-07-2025
Processing Time Days
378
Number Of Sites
1
Number Of Participants
17

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Servicio de Hematología
Principal Investigator Name
Paula Rodríguez
Principal Investigator Email
paurodriguez@unav.es
Contact Person Name
Paula Rodríguez
Contact Person Email
paurodriguez@unav.es
Number Of Participants
17

Norway

Earliest CTIS Part Ii Submission Date
24-06-2024
Latest Decision Or Authorization Date
03-03-2026
Processing Time Days
617
Number Of Sites
1
Number Of Participants
12

Sites

Site Name
Oslo University Hospital HF
Department Name
Oslo Myeloma Center
Principal Investigator Name
Fredrik Schjesvold
Principal Investigator Email
fschjesv@ous-hf.no
Contact Person Name
Fredrik Schjesvold
Contact Person Email
fschjesv@ous-hf.no
Number Of Participants
12

Sponsor

Primary sponsor

Full Name
Genentech Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Investigational products

Investigational Product Name
XmAb24306
Investigational Product Name
Cevostamab
Combination Treatment
Yes

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