Clinical trial • Phase I/II • Haematology
TECLISTAMAB for Relapsed/refractory multiple myeloma
Phase I/II trial of TECLISTAMAB for Relapsed/refractory multiple myeloma. open-label, adaptive. 231 participants.
Overview
- Trial Therapeutic Area
- Haematology
- Trial Disease
- Relapsed/refractory multiple myeloma
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody|Other antibody
Key dates
- Initial CTIS Submission Date
- 29-05-2024
- First CTIS Authorization Date
- 31-07-2024
Trial design
open-label, adaptive Phase I/II trial across 22 sites in Belgium, France, Germany and others.
- Open Label
- Yes
- Adaptive
- True - First-in-human dose-escalation design to identify proposed RP2D(s) and schedule; Part 1 dose escalation assesses frequency and type of DLTs to determine RP2D(s). Specific escalation algorithm/rules not provided in the available summary.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 231
Eligibility
Recruits 231 Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent obtained using subject information sheets and informed consent forms; multiple country/language ICFs are provided (documents include ICFs and SIS in French, Spanish, Dutch, Swedish, German, Italian, etc.). Specific ICFs are available for pregnant patients and pregnant partners. No assent procedures for minors are mentioned in the available documents..
- Pregnancy Exclusion
- A female participant of childbearing potential must have a negative pregnancy test at screening
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Informed consent obtained using subject information sheets and informed consent forms; multiple country/language ICFs are provided (documents include ICFs and SIS in French, Spanish, Dutch, Swedish, German, Italian, etc.). Specific ICFs are available for pregnant patients and pregnant partners. No assent procedures for minors are mentioned in the available documents.
Inclusion criteria
- {"criterion_text":"-Documented diagnosis of multiple myeloma according to IMWG diagnostic criteria"}
- {"criterion_text":"-Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1"}
- {"criterion_text":"-Measurable disease: Cohort A and Cohort C: Multiple myeloma must be measurable by central laboratory assessment"}
- {"criterion_text":"-A female participant of childbearing potential must have a negative pregnancy test at screening"}
- {"criterion_text":"-Willing and able to adhere to the prohibitions and restrictions specified in this protocol"}
- {"criterion_text":"-Cohorts A: received at least 3 prior MM treatment lines of therapy. Prior therapy must include an IMiD, PI, and anti-CD38 monoclonal antibody; Cohort C: received ≥ 3 prior lines of therapy that included a PI, an IMiD, an anti-CD38 monoclonal antibody, and an anti-B cell maturation antigen (BCMA) treatment (with CART-T cells or an antibody drug conjugate (ADC)"}
Exclusion criteria
- {"criterion_text":"-Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light-chain amyloidosis"}
- {"criterion_text":"-Prior autologous stem cell transplant ≤ 12 weeks"}
- {"criterion_text":"-Live, attenuated vaccine within 4 weeks prior to the first dose of teclistamab"}
- {"criterion_text":"-The following medical conditions: Pulmonary compromise requiring supplemental oxygen use to maintain adequate oxygenation, human immunodeficiency virus (HIV) infection, hepatitis B or C infection, stroke or seizure less than or equal to (≤) 6 m, autoimmune disease, uncontrolled systemic infection, cardiac conditions (Myocardial Infarction ≤ 6 m, stage III-IV congestive heart failure, etc)"}
- {"criterion_text":"-Received any therapy that is targeted to BCMA, with the exception of Cohort C in Part 3"}
- {"criterion_text":"-Prior antitumor therapy, within 21 days (PI or radiotherapy within 14 days, IMiDs within 7 days, Gene modified adoptive cell therapy within 3 months) prior to first dose of study drug"}
- {"criterion_text":"-Toxicities from previous anticancer therapies that have not resolved to baseline or to ≤ grade 1 (except for alopecia or peripheral neuropathy)"}
- {"criterion_text":"-Received a cumulative dose of corticosteroids equivalent to ≥ 140 mg of prednisone within the 14-day period before the first dose of study drug (does not include pretreatment medication)"}
- {"criterion_text":"-Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma (MM)"}
- {"criterion_text":"-Myelodysplastic syndrome or active malignancies other than relapsed/refractory multiple myeloma with exceptions are: 1) Non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured 2) Skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured. 3) Noninvasive cervical cancer treated within the last 24 months that is considered completely cured. 4) Localized prostate cancer (N0M0) 5) Breast cancer: Adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence. 6) Malignancy that is considered cured with minimal risk of recurrence"}
- {"criterion_text":"-Prior allogenic stem cell transplant ≤ 6 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Part 1 (Dose Escalation): Frequency and type of DLT; Part 2 (Dose Expansion): Occurrence and severity of adverse events, serious adverse events, and laboratory values; Part 3 (Phase 2): ORR (PR or better) as defined by the IMWG criteria","definition_or_measurement_approach":"Part 1: frequency and type of dose-limiting toxicities (DLTs); Part 2: occurrence and severity of adverse events (AEs), serious adverse events (SAEs), and laboratory values; Part 3: Overall Response Rate (ORR; partial response [PR] or better) measured per IMWG criteria (as stated)"}
Recruitment
- Planned Sample Size
- 231
- Recruitment Window Months
- 122
- Consent Approach
- Informed consent is obtained using subject information sheets and informed consent forms. Multiple country-specific ICF documents and translations are provided (examples: French, Spanish, Dutch, Swedish, German, Italian). There are specific ICFs for pregnant patients and pregnant partners. Consent is obtained from participants (no mention of assent or minor-specific consent documents).
Geography
- Total Number Of Sites
- 22
- Total Number Of Participants
- 267
Belgium
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 01-08-2024
- Processing Time Days
- 49
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematologie
- Principal Investigator Name
- Fritz Offner
- Principal Investigator Email
- fritz.offner@uzgent.be
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Hematologie
- Principal Investigator Name
- Michel Delforge
- Principal Investigator Email
- michel.delforge@uzleuven.be
- Contact Person Name
- Michel Delforge
- Contact Person Email
- michel.delforge@uzleuven.be
France
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 28-01-2026
- Processing Time Days
- 594
- Number Of Sites
- 6
- Number Of Participants
- 98
Sites
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d'Hématologie et Thérapie Cellulaire
- Principal Investigator Name
- Xavier LELEU
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier LELEU
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Toulouse
- Department Name
- Service d'hématologie
- Principal Investigator Name
- Aurore PERROT
- Principal Investigator Email
- Perrot.Aurore@iuct-oncopole.fr
- Contact Person Name
- Aurore PERROT
- Contact Person Email
- Perrot.Aurore@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service d'hématologie clinique
- Principal Investigator Name
- Philippe MOREAU
- Principal Investigator Email
- philippe.moreau@chu-nantes.fr
- Contact Person Name
- Philippe MOREAU
- Contact Person Email
- philippe.moreau@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service d'Hématologie Clinique Pavillon 1F
- Principal Investigator Name
- Lionel KARLIN
- Principal Investigator Email
- lionel.karlin@chu-lyon.fr
- Contact Person Name
- Lionel KARLIN
- Contact Person Email
- lionel.karlin@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service des maladies du sang
- Principal Investigator Name
- Salomon MANIER
- Principal Investigator Email
- salomon.manier@chru-lille.fr
- Contact Person Name
- Salomon MANIER
- Contact Person Email
- salomon.manier@chru-lille.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Service d'Hématologie et de Thérapie Cellulaire
- Principal Investigator Name
- Thomas CHALOPIN
- Principal Investigator Email
- t.chalopin@chu-tours.fr
- Contact Person Name
- Thomas CHALOPIN
- Contact Person Email
- t.chalopin@chu-tours.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 09-09-2025
- Processing Time Days
- 453
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Abt. f. Innere Medizin II, Haematologie/Onkologie/Rheumatologie
- Principal Investigator Name
- Britta Besemer
- Principal Investigator Email
- britta.besemer@med.uni-tuebingen.de
- Contact Person Name
- Britta Besemer
- Contact Person Email
- britta.besemer@med.uni-tuebingen.de
- Site Name
- Universitaet Leipzig
- Department Name
- Med. Klinik und Poliklinik I - Bereich Haematologie und Zelltherapie
- Principal Investigator Name
- Vladan Vucinic
- Principal Investigator Email
- vladan.vucinic@medizin.uni-leipzig.de
- Contact Person Name
- Vladan Vucinic
- Contact Person Email
- vladan.vucinic@medizin.uni-leipzig.de
Italy
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 30-01-2026
- Processing Time Days
- 596
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- UO Ematologia
- Principal Investigator Name
- Monica Galli
- Principal Investigator Email
- monicagalli@asst-pg23.it
- Contact Person Name
- Monica Galli
- Contact Person Email
- monicagalli@asst-pg23.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- SC Ematologia - Dipartimento di Oncologia Medica ed Ematologia
- Principal Investigator Name
- Paolo Corradini
- Principal Investigator Email
- paolo.corradini@unimi.it
- Contact Person Name
- Paolo Corradini
- Contact Person Email
- paolo.corradini@unimi.it
Spain
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 595
- Number Of Sites
- 6
- Number Of Participants
- 75
Sites
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Carmen Martinez-Chamorro
- Principal Investigator Email
- carmenmartinezchamorro@hotmail.com
- Contact Person Name
- Carmen Martinez-Chamorro
- Contact Person Email
- carmenmartinezchamorro@hotmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Albert Oriol Rocafiguera
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol Rocafiguera
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Laura Rosiñol Dachs
- Principal Investigator Email
- LROSINOL@clinic.cat
- Contact Person Name
- Laura Rosiñol Dachs
- Contact Person Email
- LROSINOL@clinic.cat
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Maria Victoria Mateos Manteca
- Principal Investigator Email
- matemateos@saludcastillayleon.es
- Contact Person Name
- Maria Victoria Mateos Manteca
- Contact Person Email
- matemateos@saludcastillayleon.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Joaquin Martinez Lopez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez Lopez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Servicio de Hematología
- Principal Investigator Name
- Paula Rodríguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodríguez Otero
- Contact Person Email
- paurodriguez@unav.es
Sweden
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 595
- Number Of Sites
- 3
- Number Of Participants
- 34
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Hematologkliniken
- Principal Investigator Name
- Cecilie Blimark
- Principal Investigator Email
- cecilie.blimark@vgregion.se
- Contact Person Name
- Cecilie Blimark
- Contact Person Email
- cecilie.blimark@vgregion.se
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Hematologimottagning Klinisk forskningsmottagning
- Principal Investigator Name
- Markus Hansson
- Principal Investigator Email
- markus.hansson@med.lu.se
- Contact Person Name
- Markus Hansson
- Contact Person Email
- markus.hansson@med.lu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Hematologiskt Centrum
- Principal Investigator Name
- Katarina Uttervall
- Principal Investigator Email
- katarina.uttervall@regionstockholm.se
- Contact Person Name
- Katarina Uttervall
- Contact Person Email
- katarina.uttervall@regionstockholm.se
Netherlands
- Earliest CTIS Part Ii Submission Date
- 13-06-2024
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 599
- Number Of Sites
- 1
- Number Of Participants
- 44
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- Hematology
- Principal Investigator Name
- Niels van de Donk
- Principal Investigator Email
- hematology@amsterdamumc.nl
- Contact Person Name
- Niels van de Donk
- Contact Person Email
- hematology@amsterdamumc.nl
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Signant Health Global LLC
- Responsibilities
- code: 3
- Name
- Fisher Clinical Services GmbH
- Responsibilities
- code: 14
- Name
- Navigate Biopharma Services Inc.
- Responsibilities
- code: 4
- Name
- Arup Laboratories Inc.
- Responsibilities
- code: 4
- Name
- Frontage Laboratories Inc.
- Responsibilities
- code: 4
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- code: 4
- Name
- Medidata Solutions Inc.
- Responsibilities
- code: 6
- Name
- Adaptive Biotechnologies Corp.
- Responsibilities
- code: 4
- Name
- Cellcarta Biosciences Inc.
- Responsibilities
- code: 4
- Name
- SGS Belgium
- Responsibilities
- code: 6
- Name
- Parexel International Corp.
- Responsibilities
- code: 6
- Name
- Venn Life Sciences Ed B.V.
- Responsibilities
- code: 4
- Name
- Q Squared Solutions Holdings LLC
- Responsibilities
- code: 4
Third parties
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Frontage Laboratories Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code: 6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"code: 14","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"Venn Life Sciences Ed B.V.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q Squared Solutions Holdings LLC","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- teclistamab
- Active Substance
- TECLISTAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Authorisation Status
- prodAuthStatus: 1
- First In Human
- Yes
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