Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
100
Countries
5
Sites
29
Relapsed/Refractory Multiple Myeloma
Key facts
- Sponsor
- Janssen Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 3 Jun 2024 → ongoing
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Relapsed/Refractory Multiple Myeloma
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen Cilag International
- Sponsor organisation
- Janssen Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen Cilag International
- Contact name
- CTIS Point of Contact
Locations
5 EU/EEA countries · 29 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 10 | 4 |
| Germany | Ongoing, recruitment ended | 10 | 4 |
| Italy | Ongoing, recruitment ended | 10 | 6 |
| Poland | Ongoing, recruitment ended | 9 | 7 |
| Spain | Ongoing, recruitment ended | 9 | 8 |
| Rest of world
Korea, Republic of, Australia, Canada, United States, United Kingdom
|
— | 52 | — |
Investigational sites
Hospices Civils De Lyon
Hematology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Lille
Blood diseases service, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Nantes
Hematology Department, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Hematology Department, Avenue De Magellan, 33600, Pessac
Poliklinik gGmbH Chemnitz
Klinik für Innere Medizin III, Buergerstrasse 33, Schlosschemnitz, Chemnitz
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Heidelberg AöR
Innere Medizin V, Haematologie, Onkologie und Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
UO Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Delle Marche
SOD Clinica Ematologica, Via Conca 71, 60126, Ancona
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UO Ematologia, Largo Francesco Vito 1, 00168, Rome
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
UO Ematologia, Piazza Oms 1, 24127, Bergamo
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
UO Oncoematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero Universitaria Pisana
UO Ematologia, Via Roma 67, 56126, Pisa
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Centrum Hematologiczno-Transplantacyjne, Ul. Grabiszynska 105, 53-439, Wroclaw
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Medical University Of Warsaw
Klinika Hematologii, Transplantologii i Chorób Wewnętrznych, Ul. Stefana Banacha 1a, 02-097, Warsaw
Wojewodzki Szpital Specjalistyczny W Bialej Podlaskiej
Oddział Hematologii, Ul. Terebelska 57/65, 21-500, Biala Podlaska
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Quironsalud Madrid
Hematology, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
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 | 2024-06-03 | 2024-07-16 | 2025-03-03 | ||
| Germany | 2024-06-04 | 2024-08-06 | 2025-03-03 | ||
| Italy | 2024-06-05 | 2024-07-27 | 2025-03-03 | ||
| Poland | 2024-06-10 | 2024-07-22 | 2025-03-03 | ||
| Spain | 2024-06-10 | 2024-07-08 | 2025-03-03 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | France | Acceptable 2024-06-03
|
2024-06-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-18 | France | Acceptable 2025-02-19
|
2025-02-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-11-07 | France | Acceptable 2026-02-02
|
2026-02-02 |