Clinical trial • Phase IV • Oncology
ISATUXIMAB for Multiple myeloma|Plasma cell myeloma
Phase IV trial of ISATUXIMAB for Multiple myeloma|Plasma cell myeloma. open-label, none/not specified-controlled. 29 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma|Plasma cell myeloma
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 20-12-2023
- First CTIS Authorization Date
- 15-04-2024
Trial design
open-label, none/not specified-controlled Phase IV trial in Spain, Greece, Czechia and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 29
Eligibility
Recruits 29 Vulnerable populations are acknowledged (isVulnerablePopulationSelected = true). Participants must be ≥18 and capable of giving signed informed consent; individuals incarcerated or legally institutionalised are explicitly excluded. Multiple subject information and informed consent form variants (including partner/pregnancy and adolescent/parents versions) are provided in several languages, and capacity to consent is assessed by the Investigator..
- Pregnancy Exclusion
- - Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants.
- Vulnerable Population
- Vulnerable populations are acknowledged (isVulnerablePopulationSelected = true). Participants must be ≥18 and capable of giving signed informed consent; individuals incarcerated or legally institutionalised are explicitly excluded. Multiple subject information and informed consent form variants (including partner/pregnancy and adolescent/parents versions) are provided in several languages, and capacity to consent is assessed by the Investigator.
Inclusion criteria
- {"criterion_text":"- Participant must be ≥18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the informed consent."}
- {"criterion_text":"- Participants of a parental Phase 1, 2, or 3 clinical study assessing isatuximab monotherapy or in a combination regimen with all the study objectives completed."}
- {"criterion_text":"- Participants still receiving isatuximab at the time of the parental study closure, who are continuing to benefit from isatuximab as monotherapy or in combination, as determined by the treating physician, and who meet the criteria to initiate a subsequent cycle of therapy as described in the parental study protocol. A participant not receiving isatuximab at the end of the parental study who does not have access locally to the ongoing treatment may also be included."}
- {"criterion_text":"- Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants."}
- {"criterion_text":"- Capable of giving signed informed consent."}
- {"criterion_text":"- Contraception (with double contraception methods) for male and female participants; not pregnant or breastfeeding for female participants; no sperm donation for male participants."}
Exclusion criteria
- {"criterion_text":"- Participant has evidence of progressive disease during or at the time of the parental study closure."}
- {"criterion_text":"- Participant has not recovered to ≤Grade 2 from non-hematologic AEs (as per NCI CTCAE v5.0) related to any anticancer therapy received prior to signing informed consent on the extension study."}
- {"criterion_text":"- As the latest line of treatment participant received an antimyeloma therapy other than the isatuximab-based therapy in the parental study before the first IMP in this study."}
- {"criterion_text":"- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized."}
- {"criterion_text":"- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures."}
- {"criterion_text":"- Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals"}
- {"criterion_text":"- Any country-related specific regulation that would prevent the participant from entering the study."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of participants with treatment-emergent adverse events","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 29
- Recruitment Window Months
- 45
- Consent Approach
- Participants must provide signed informed consent (participants must be capable of giving signed informed consent). Subject information and informed consent forms (including pregnancy/partner and adolescent/parent versions) are provided in multiple languages (documents listed for ES, EL, SV, FR, FI, CS, IT, etc.). Investigator assessment of capacity is required and specific consent/privacy documents are available.
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 37
Spain
- Latest Decision Or Authorization Date
- 16-04-2024
- Number Of Sites
- 6
- Number Of Participants
- 24
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Clinical Hematology department
- Contact Person Name
- Albert Oriol
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Beatriz Rey Bua
- Contact Person Email
- vgcalle@saludcastillayleon.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Hematology department
- Contact Person Name
- Estrella Carrillo Cruz
- Contact Person Email
- estrellacarrillocruz@gmail.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Enrique Ocio
- Contact Person Email
- ocioem@unican.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Joaquin Martinez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Paula Rodriguez Otero
- Contact Person Email
- paurodriguez@unav.es
Greece
- Latest Decision Or Authorization Date
- 22-04-2024
- Number Of Sites
- 3
- Number Of Participants
- 1
Sites
- Site Name
- General University Hospital Of Patras
- Department Name
- Bone Marrow Transplantation Unit
- Contact Person Name
- Alexandros Spyridonidis
- Contact Person Email
- spyridonidis@upatras.gr
- Site Name
- Evangelismos S.A.
- Department Name
- Department of Hematology and Bone Marrow Transplantation Unit
- Contact Person Name
- SOSANA DELIMPASI
- Contact Person Email
- sodeli@yahoo.com
- Site Name
- Alexandra Hospital
- Department Name
- Department of Clinical Therapeutics
- Contact Person Name
- Meletios-Athanasios Dimopoulos
- Contact Person Email
- mdimop@med.uoa.gr
Czechia
- Latest Decision Or Authorization Date
- 16-04-2024
- Number Of Sites
- 3
- Number Of Participants
- 1
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematoonkologie
- Contact Person Name
- Roman Hajek
- Contact Person Email
- roman.hajek@fno.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- I. interni klinika
- Contact Person Name
- Ivan Spicka
- Contact Person Email
- spicka@cesnet.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní Hematologická a Onkologická Klinika
- Contact Person Name
- Ludek Pour
- Contact Person Email
- pour.ludek@fnbrno.cz
Finland
- Latest Decision Or Authorization Date
- 15-04-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- HUS-Yhtymae
- Department Name
- Comprehensive Cancer Center
- Contact Person Name
- Pekka Anttila
- Contact Person Email
- pekka.anttila@hus.fi
France
- Latest Decision Or Authorization Date
- 17-04-2024
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service d'Hematologie
- Contact Person Name
- Philippe Moreau
- Contact Person Email
- philippe.moreau@chu-nantes.fr
Sweden
- Latest Decision Or Authorization Date
- 16-04-2024
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Region Norrbotten
- Department Name
- Sunderby sjukhus
- Contact Person Name
- Birgitta Lauri
- Contact Person Email
- birgitta.lauri@norrbotten.se
Italy
- Latest Decision Or Authorization Date
- 19-04-2024
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
- Department Name
- Department of Molecular Biotechnology and Health Sciences
- Contact Person Name
- Alessandra Larocca
- Contact Person Email
- alessandra.larocca@unito.it
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Suvoda LLC
- Name
- Sermes CRO
- Responsibilities
- Patients' reimbursement for meals or accommodation
- Name
- ESMS Global Limited
- Responsibilities
- Centralized 24-Hour Emergency System
Third parties
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"AxMP Management: only ancilliary supply management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Taxi Travel Ticket S.L.","duties_or_roles":"Patient transportation from home to site and site to home","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"Patients' reimbursement for meals or accommodation","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Isatuximab
- Active Substance
- ISATUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION / INTRAVENIOUS INFUSION
- Combination Treatment
- Yes
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