Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
385
Countries
4
Sites
27
Relapsed/Refractory Multiple Myeloma
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Aug 2022 → ongoing
- Decision date (initial)
- 2024-07-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506247-42-00
- EudraCT number
- 2020-004638-39
- ClinicalTrials.gov
- NCT05137054
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory Multiple Myeloma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10028228 | Multiple myeloma | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Medical Affairs
Locations
4 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 88 | 10 |
| Greece | Ongoing, recruiting | 70 | 2 |
| Netherlands | Authorised, recruitment pending | 40 | 2 |
| Spain | Ongoing, recruiting | 111 | 13 |
| Rest of world
Israel, United States
|
— | 76 | — |
Investigational sites
Centre Hospitalier Universitaire De Poitiers
Service d’hématologie et Thérapie Cellulaire Pôle Régional de Cancérologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire D'Angers
Service Maladies du Sang, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Montpellier
Hematologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Centre Hospitalier Universitaire De Lille
Département d’hématologie, Rue Michel Polonowski, 59000, Lille
Institut Gustave Roussy
Hématologie, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nantes
Département d'hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Service Immuno-hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Assistance Publique Hopitaux De Paris
Hémopathies Lymphoïdes, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Assistance Publique Hopitaux De Paris
Département d'hématologie, 149 Rue De Sevres, 75015, Paris
Assistance Publique Hopitaux De Paris
Hématologie Clinique et thérapie cellulaire, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Alexandra Hospital
Oncology and Hematology Unit, Department of Clinical, Vassilissas Sofias Avenue 80, 115 28, Athens
Evaggelismos Hospital
Hematology and Lymphoma Clinic – Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
VUMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Complexo Hospitalario Universitario De Santiago
Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario De La Princesa
Hematology, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Hm Sanchinarro
Hematology, Calle Ona 10, 28050, Madrid
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-03-27 | 2023-03-27 | |||
| Greece | 2022-11-16 | 2022-11-16 | |||
| Spain | 2022-08-17 | 2022-08-17 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-22 | Spain | Acceptable 2024-06-27
|
2024-06-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-10 | Spain | Acceptable 2024-11-28
|
2024-11-28 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-30 | Spain | Acceptable with conditions 2025-08-28
|
2025-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-05 | Acceptable with conditions | 2026-02-02 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-05 | Acceptable with conditions | 2026-01-15 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-12-05 | Acceptable with conditions 2025-08-28
|
2026-03-06 |