Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
228
Countries
1
Sites
8
Multiple Myeloma
Part 1: To identify the RP2R(s) and schedule for the study treatment Part 2: To characterize the safety of the RP2R(s) for the study treatment Part 3: To evaluate the anticancer activity of tal+tec in participants with relapsed or refractory multiple myeloma and EMD
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
- 29 Dec 2020 → ongoing
- Decision date (initial)
- 2024-08-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503439-16-00
- EudraCT number
- 2019-004124-38
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Others, Dose response, Pharmacodynamic, Efficacy, Pharmacokinetic
Part 1: To identify the RP2R(s) and schedule for the study treatment
Part 2: To characterize the safety of the RP2R(s) for the study treatment
Part 3: To evaluate the anticancer activity of tal+tec in participants with relapsed or refractory multiple myeloma and EMD
Conditions and MedDRA coding
Multiple Myeloma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria
- Part 1 and 2: Participant could not tolerate or has disease that is relapsed or refractory to established therapies, including the last line of therapy. Part 3: (a) Relapsed or refractory disease, and exposed to a PI, IMiD, and an anti-CD38 mAb; (b) Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
- Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1 at screening and immediately before the start of study drug administration. Part 3: ECOG performance status grade of 0, 1, or 2 at screening and immediately before the start of study drug administration
Exclusion criteria 4
- All Parts: Targeted therapy, epigenetic therapy, or treatment with an investigational treatment or an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is less. Part 3: prior BCMA targeted bispecific antibody therapy; prior GPRC5D targeted therapy
- All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment.
- All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma.
- All Parts: Active plasma cell leukemia (greater than [>]2.0*10^9/L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, M- protein, and skin changes), or primary amyloid light chain amyloidosis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Part 1 and Part 2 •Incidence and severity of DLTs •Incidence and severity of AEs and SAEs
- Part 3 •ORR as evaluated by IRC
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD10381753 · Product
- Active substance
- Talquetamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2486
PRD10381752 · Product
- Active substance
- Talquetamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2486
PRD9936206 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD9936207 · Product
- Active substance
- Teclistamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 1
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- repackaged and relabeled
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
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Ancillare LP ORG-100044089
|
Horsham, United States | Other |
| Navigate Biopharma Services Inc. ORG-100032721
|
Carlsbad, United States | Other |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Parexel International Corp. ORG-100007310
|
Durham, United States | Data management |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other |
| Hematogenix Laboratory Services LLC ORG-100040020
|
Tinley Park, United States | Laboratory analysis |
| SGS Belgium ORG-100007917
|
Mechelen, Belgium | Data management |
| Cellcarta Biosciences Inc. ORG-100042227
|
Montreal, Canada | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| Fisher Clinical Services UK Limited ORG-100012049
|
Horsham, United Kingdom | Other |
Locations
1 EU/EEA country · 8 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 51 | 8 |
| Rest of world
Canada, United States, Israel, Korea, Republic of, Australia
|
— | 177 | — |
Investigational sites
Hospital Universitario Marques De Valdecilla
Hematología, Avenida Valdecilla Sn, 39008, Santander
Institut Catala D'oncologia
Hematology Department and Hematopoietic Stem Cell Transplant Programme, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario 12 De Octubre
Hematología, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario De Salamanca
Hematología y Hemoterapia, Paseo De San Vicente 58-182, 37007, Salamanca
Institut Catala D'oncologia
Hematología Clínica, Carretera Canyet S/n, 08916, Badalona
Clinica Universidad De Navarra
Hematology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Clinic De Barcelona
Hematología, 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 |
|---|---|---|---|---|---|
| Spain | 2020-12-29 | 2020-12-29 | 2024-10-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | REDACTED_D1_Protocol 2023-503439-16 | AM10 |
| Recruitment arrangements (for publication) | REDACTED_K1_Recruitment Arrangements_ES_SPA_2023-503439-16 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Dara Tecli Talque_ES_SPA_2023-503439-16 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Part 3_ES_SPA_2023-503439-16 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Tecli Talque_ES_SPA_2023-503439-16 | 16 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_SPA_2023-503439-16 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient_ES_SPA_2023-503439-16 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_SPA_2023-503439-16 | 2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2023-503439-16 | AM10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-08 | Spain | Acceptable with conditions 2024-08-14
|
2024-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-21 | Spain | Acceptable 2025-03-10
|
2025-03-10 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-16 | Spain | Acceptable 2026-04-13
|
2026-04-20 |