Clinical trial • Phase I/II • Oncology|Haematology
TALQUETAMAB for Multiple myeloma|Relapsed or refractory multiple myeloma
Phase I/II trial of TALQUETAMAB for Multiple myeloma|Relapsed or refractory multiple myeloma. open-label, none/not specified-controlled, adaptive.
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- Multiple myeloma|Relapsed or refractory multiple myeloma
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody|Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 08-08-2024
- First CTIS Authorization Date
- 14-08-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial across 8 sites in Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose-escalation and expansion design to identify the RP2R(s) and schedule (Part 1/2); specific escalation rules/interim analysis/stopping rules not provided in metadata.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 177
Eligibility
Recruits 177 Vulnerable population selected (flag present). Subject information and informed consent form documents are listed (multiple L1 SIS and ICF documents, Spanish versions). No explicit assent/consent handling text or details on consent providers for vulnerable subjects are provided in the available metadata..
- Vulnerable Population
- Vulnerable population selected (flag present). Subject information and informed consent form documents are listed (multiple L1 SIS and ICF documents, Spanish versions). No explicit assent/consent handling text or details on consent providers for vulnerable subjects are provided in the available metadata.
Inclusion criteria
- {"criterion_text":"-Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria"}
- {"criterion_text":"-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"}
- {"criterion_text":"-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
- {"criterion_text":"-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"}
- {"criterion_text":"-All Parts: Allogeneic stem cell transplant within 6 months before the first dose of study treatment."}
- {"criterion_text":"-All Parts: Central nervous system involvement or clinical signs of meningeal involvement of multiple myeloma."}
- {"criterion_text":"-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 endpoints
- {"endpoint_text":"-Part 1 and Part 2 •Incidence and severity of DLTs •Incidence and severity of AEs and SAEs","definition_or_measurement_approach":""}
- {"endpoint_text":"-Part 3 •ORR as evaluated by IRC","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 177
- Recruitment Window Months
- 83
- Consent Approach
- Informed consent required from participants; subject information and informed consent form documents are provided (multiple L1 SIS and ICF documents, Spanish versions present). No further details on assent, age-specific documents or additional languages available are provided in the metadata.
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 177
Spain
- Earliest CTIS Part Ii Submission Date
- 16-07-2024
- Latest Decision Or Authorization Date
- 20-04-2026
- Processing Time Days
- 643
- Number Of Sites
- 8
- Number Of Participants
- 51
Sites
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hematología
- Principal Investigator Name
- Enrique María Ocio San Miguel
- Principal Investigator Email
- enriquem.ocio@unican.es
- Contact Person Name
- Enrique María Ocio San Miguel
- Contact Person Email
- enriquem.ocio@unican.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Daniel Morillo
- Principal Investigator Email
- dmorillo@startmadrid.com
- Contact Person Name
- Daniel Morillo
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematología y Hemoterapia
- Principal Investigator Name
- María Victoria Mateos
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- María Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematología
- Principal Investigator Name
- Joaquín Martínez López
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquín Martínez López
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- 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
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodríguez Otero
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodríguez Otero
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Hematología Clínica
- Principal Investigator Name
- Albert Oriol
- Principal Investigator Email
- aoriol@iconcologia.net
- Contact Person Name
- Albert Oriol
- Contact Person Email
- aoriol@iconcologia.net
- Site Name
- Institut Catala D'oncologia (L'hospitalet De Llobregat)
- Department Name
- Hematology Department and Hematopoietic Stem Cell Transplant Programme
- Principal Investigator Name
- Anna Sureda Balari
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Anna Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Contract research organisations
- Name
- Parexel International Corp.
Third parties
- {"country":"United States","full_name":"Ancillare LP","duties_or_roles":"Ancillare Supplies","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"Biomarker and Specialty Lab Services","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Central Imaging Read","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Interactive Web Response Technologies (IWRS)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"BM MRD Anaylsis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Canada","full_name":"Cellcarta Biosciences Inc.","duties_or_roles":"Serum Cytokine Panel Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"SGS Belgium","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Fisher Clinical Services UK Limited","duties_or_roles":"Distribution","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- JNJ-64407564
- Active Substance
- TALQUETAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Orphan Designation
- Yes
- Investigational Product Name
- teclistamab
- Active Substance
- TECLISTAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous use
- Route
- Subcutaneous
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.
- DAUNORUBICIN HYDROCHLORIDE for Acute myeloid leukemia|Relapsed or refractory acute myeloid leukemia
- Brentuximab vedotin for Peripheral T-cell lymphoma (PTCL) | Anaplastic large cell lymphoma (ALCL) | Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) | Angioimmunoblastic T-cell lymphoma (AITL) | Adult T-cell leukaemia/lymphoma (ATLL) | Enteropathy-associated T-cell lymphoma (EATL) | Hepatosplenic T-cell lymphoma | Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) | Indolent T-cell lymphoproliferative disorder of the gastrointestinal tract | Follicular T-cell lymphoma | Nodal peripheral T-cell lymphoma with T-follicular helper phenotype
- RITUXIMAB for Diffuse large B-cell lymphoma (ABC)
- Lenalidomide for Primary central nervous system lymphoma
- Cytarabine; Daunorubicin for Myelodysplastic syndrome (higher-risk)|Oligoblastic acute myeloid leukaemia (AML)