Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
250
Countries
4
Sites
19
Relapsed and refractory multiple myeloma (RRMM)
Key facts
- Sponsor
- Celgene International II S.a.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 May 2018 → 18 Mar 2025
- Decision date (initial)
- 2023-10-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506564-14-00
- EudraCT number
- 2017-003448-19
- WHO UTN
- U1111-1210-6325
- ClinicalTrials.gov
- NCT03486067
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed and refractory multiple myeloma (RRMM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 16.1 | HLT | 10028229 | Multiple myelomas | 10029104 |
| 21.1 | LLT | 10067095 | Multiple myeloma progression | 10029104 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene International II S.a.r.l.
- Sponsor organisation
- Celgene International II S.a.r.l.
- Address
- Route De Perreux 1
- City
- Boudry
- Postcode
- 2017
- Country
- Switzerland
Scientific contact point
- Organisation
- Celgene International II S.a.r.l.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene International II S.a.r.l.
- Contact name
- GSM-CT
Locations
4 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 10 | 4 |
| Italy | Ended | 18 | 3 |
| Spain | Ended | 64 | 8 |
| Sweden | Ended | 20 | 4 |
| Rest of world
Japan, United States
|
— | 138 | — |
Investigational sites
Universitaetsklinikum Heidelberg AöR
Medical Department V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Technical University Of Munich School Of Medicine
Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Erlangen AöR
Medical Department V, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Tuebingen AöR
Medical Department II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Azienda Ospedaliera Papa Giovanni XXIII
Hematology and Bone Marrow Transplant Unit, Piazza Oms 1, 24127, Bergamo
Humanitas Research Hospital
Oncology and Hematology, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Hematology Division, Via Piero Maroncelli 40, 47014, Meldola
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Dr Peset Aleixandre
Hematology, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Karolinska University Hospital
Cancerstudieenheten Huddinge M62|ME Centrum för kliniska Cancerstudier, Halsovagen, Flemingsberg, Huddinge
Region Skane Skanes Universitetssjukhus
Hematology, Getingevägen 4, Lund, Entregatan 7, 222 42, Lund
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Hematology, Bruna stråket 5, våning 5, Bla Straket 5, 413 46, Goteborg
Uppsala University Hospital
Hematology, Akademiska Sjukhuset, 751 85, Uppsala
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 |
|---|---|---|---|---|---|
| Germany | 2022-03-25 | 2025-03-11 | 2022-05-30 | 2024-05-16 | |
| Italy | 2020-08-14 | 2020-12-14 | 2024-05-16 | ||
| Spain | 2018-05-16 | 2018-08-13 | 2024-05-16 | ||
| Sweden | 2020-09-11 | 2024-12-31 | 2020-09-22 | 2024-05-16 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-05 | Sweden | Acceptable 2023-10-06
|
2023-10-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-12-18 | Sweden | Acceptable 2024-03-04
|
2024-03-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-06-27 | Sweden | Acceptable 2024-03-04
|
2024-06-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-05 | Sweden | Acceptable 2024-08-19
|
2024-08-19 |
| 5 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-02-24 | Sweden | Acceptable 2025-04-14
|
2025-04-15 |