Clinical trial • Phase III • Oncology
Cevostamab for Relapsed or refractory multiple myeloma
Phase III trial of Cevostamab for Relapsed or refractory multiple myeloma. 35 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory multiple myeloma
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 08-07-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
Phase III trial across 6 sites in Belgium, Greece, Italy.
- Target Sample Size
- 35
Eligibility
Recruits 35 Vulnerable population selected; no details on consent or assent handling are provided in the available record..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling are provided in the available record.
Recruitment
- Planned Sample Size
- 35
- Recruitment Window Months
- 49
- Consent Approach
- No information on the informed consent or assent process is provided in the available record; vulnerable population selection is indicated but age-specific consent/assent documents or languages are not described.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 45
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-01-2023
- Latest Decision Or Authorization Date
- 07-07-2025
- Processing Time Days
- 902
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Contact Person Name
- Nicolas Kint
- Contact Person Email
- nicolas.kint@uzgent.be
- Site Name
- UZ Brussel
- Department Name
- Hematology
- Contact Person Name
- Henri Schots
- Contact Person Email
- rik.schots@uzbrussel.be
Greece
- Earliest CTIS Part Ii Submission Date
- 17-01-2023
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 1107
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Alexandra Hospital
- Department Name
- Athens Medical School - Therapeutic Clinic
- Contact Person Name
- Meletios-Athanasios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
- Site Name
- Evangelismos S.A.
- Department Name
- Hematology Clinic
- Contact Person Name
- Sosana Delimpasi
- Contact Person Email
- sodeli@yahoo.com
Italy
- Earliest CTIS Part Ii Submission Date
- 17-01-2023
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 1107
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- U.O di Oncologia Medica ed Ematologia accreditata fase I
- Contact Person Name
- Armando Santoro
- Contact Person Email
- trials.santoro@cancercenter.humanitas.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O. di Ematologia
- Contact Person Name
- Elena Zamagni
- Contact Person Email
- e.zamagni@unibo.it
Sponsor
Primary sponsor
- Full Name
- Genentech Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- Cevostamab (BFCR4350A)
- Active Substance
- Cevostamab
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
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