Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
450
Countries
4
Sites
21
Relapsed/Refractory Multiple Myeloma
Key facts
- Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 7 Oct 2022 → ongoing
- Decision date (initial)
- 2024-01-10
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506871-88-00
- EudraCT number
- 2021-005587-22
- ClinicalTrials.gov
- NCT05259839
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
AbbVie Deutschland GmbH & Co. KG
- Sponsor organisation
- AbbVie Deutschland GmbH & Co. KG
- Address
- Knollstrasse
- City
- Ludwigshafen Am Rhein
- Postcode
- 67061
- Country
- Germany
Scientific contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Locations
4 EU/EEA countries · 21 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 50 | 5 |
| Italy | Ongoing, recruitment ended | 49 | 5 |
| Poland | Ongoing, recruitment ended | 49 | 4 |
| Spain | Ongoing, recruitment ended | 48 | 7 |
| Rest of world
United States, Japan, Australia
|
— | 254 | — |
Investigational sites
University Medical Center Hamburg-Eppendorf
N/A, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Regensburg
N/A, Franz-Josef-Straus-Allee 11, Gras-Oberisling, Ratisbon
Universitaetsklinikum Wuerzburg AöR
N/A, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Tuebingen AöR
N/A, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Essen AöR
N/A, Hufelandstrasse 55, Holsterhausen, Essen
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Haematology, Via Piero Maroncelli 40, 47014, Meldola
Ospedale San Raffaele S.r.l.
Haematology, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Haematology, Via Francesco Sforza 28, 20122, Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Haematology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Haematology, Via Pietro Albertoni 15, 40138, Bologna
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department of Hematology, Cell Therapies and Internal Diseases, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department of Hematooncology and Bone Marrow Transplantation, Ul. Stanislawa Staszica 11, 20-081, Lublin
Szpital Wojewodzki W Opolu Sp. z o.o.
Department of Hematology, Hematological Oncology and Internal Medicine, Ul. Katowicka 64, 45-061, Opole
Uniwersyteckie Centrum Kliniczne
Department of Hematology and Transplantology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitari Vall D Hebron
N/A, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
N/A, Avenida De Manuel Siurot S/n, 41013, Sevilla
Clinica Universidad De Navarra
N/A, Calle Marquesado De Santa Marta 1, 28027, Madrid
Clinica Universidad De Navarra
N/A, Avenue Pio XII 36, 31008, Pamplona
Institut Catala D'oncologia
N/A, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
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 | 2022-11-02 | 2022-12-15 | 2025-12-01 | ||
| Italy | 2022-12-14 | 2023-04-26 | 2025-12-01 | ||
| Poland | 2022-12-13 | 2023-01-10 | 2025-12-01 | ||
| Spain | 2022-10-07 | 2022-10-26 | 2025-07-15 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-20 | Germany | Acceptable 2024-01-10
|
2024-01-10 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-02 | Germany | Acceptable 2024-06-03
|
2024-06-05 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-20 | Germany | Acceptable 2024-11-25
|
2024-11-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-13 | Germany | Acceptable 2025-04-07
|
2025-04-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-04-16 | Germany | Acceptable | 2025-06-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-08-28 | Germany | Acceptable 2025-12-08
|
2025-12-10 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-23 | Germany | Acceptable 2026-02-23
|
2026-02-24 |