Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
273
Countries
5
Sites
13
Relapsed or Refractory Multiple Myeloma
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Oct 2020 → 18 Mar 2026
- Decision date (initial)
- 2024-03-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504571-25-00
- EudraCT number
- 2020-002012-46
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed or 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
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
5 EU/EEA countries · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 10 | 1 |
| Denmark | Ended | 40 | 2 |
| France | Ended | 34 | 3 |
| Italy | Ended | 62 | 4 |
| Spain | Ended | 34 | 3 |
| Rest of world
Brazil, United Kingdom, New Zealand, Australia, United States, Korea, Republic of
|
— | 93 | — |
Investigational sites
Odense University Hospital
Hæmatologisk Afdeling, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire De Lille
Service des maladies du sang, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Nantes
hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Hématologie clinique, Avenue De Magellan, 33600, Pessac
Humanitas Research Hospital
U.O. di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento di Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Ematologia e Oncologia, Via Mariano Semmola 52, 80131, Naples
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Ematologia, Via Giacomo Venezian 1, 20133, Milan
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 |
|---|---|---|---|---|---|
| Belgium | 2020-11-15 | 2026-02-23 | 2021-03-29 | 2024-07-29 | |
| Denmark | 2020-11-02 | 2026-02-18 | 2020-11-04 | 2024-07-29 | |
| France | 2021-05-31 | 2026-03-17 | 2021-06-03 | 2024-07-29 | |
| Italy | 2021-02-09 | 2021-03-17 | 2024-07-29 | ||
| Spain | 2020-10-20 | 2026-03-17 | 2021-07-01 | 2024-07-29 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-13 | Denmark | Acceptable 2024-03-14
|
2024-03-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-05-21 | Denmark | Acceptable 2024-03-14
|
2024-05-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-22 | Acceptable 2024-03-14
|
2024-05-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-14 | Acceptable | 2024-07-22 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-04 | Denmark | Acceptable | 2024-10-04 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-20 | Denmark | Acceptable 2025-03-13
|
2025-03-14 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-06-25 | Denmark | Acceptable 2025-03-13
|
2025-06-25 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-12-09 | Denmark | Acceptable 2025-03-13
|
2025-12-09 |