Bispecific T-cell Redirectors as Part of First Line Treatment in Transplant Eligible Multiple Myeloma Patients
NCT Number: NCT06505369
Acronym: TALTEC
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Multiple Myeloma
Interventions: DRUG: Daratumumab|DRUG: Bortezomib|DRUG: Lenalidomide|DRUG: Dexamethasone|DRUG: Talquetamab|DRUG: Teclistamab
Sponsor: North Estonia Medical Centre
Collaborators: Janssen Pharmaceutica
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 50
Study Design: Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-06-19
Completion Date: 2028-10
Locations: Copenhagen University Hospital (Rigshospitalet), Copenhagen, 2100, Denmark|Odense University Hospital, Odense, 5000, Denmark|Vejle hospital, Vejle, 7100, Denmark|North Estonia Medical Centre, Tallinn, 13419, Estonia|Oslo University Hospital, Oslo Myeloma Centre, Oslo, 0450, Norway|Stavanger University Hospital, Stavanger, 4068, Norway|St. Olavs Hospital, Trondheim, 7030, Norway

Summary:
This is Phase 2, open-label, multicentre, non-randomised study evaluating participants with newly diagnosed MM eligible for high-dose therapy. The goal of the study is to determine if consolidation with T-cell redirectors - Talquetamab and Teclistamab in sequence will improve the response depth: increase MRD negative CR rate.

Primary Outcome Measures: Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing consolidation with talquetamab and teclistamab., MRD measured by NGS with a sensitivity level of 10-6., 18 months approximately|Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation with talquetamab and teclistamab., MRD assessed by FDG PET-CT scan using Deauville score., 18 months approximately
Secondary Outcome Measures: Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS) after completing induction treatment with Daratumumab-VRd, MRD measured by NGS with a sensitivity level of 10-6., 6 months approximately|Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing induction treatment with Daratumumab-VRd., MRD assessed by FDG PET-CT scan using Deauville score., 6 months approximately|Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by next generation sequencing ( NGS) after completing consolidation treatment with talquetamab., MRD measured by NGS with a sensitivity level of 10-6., 12 months approximately|Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation treatment with talquetamab., MRD assessed by FDG PET-CT scan using Deauville score., 12 months approximately|Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by next generation sequencing ( NGS) after completing consolidation treatment with teclistamab., MRD measured by NGS with a sensitivity level of 10-6., 18 months approximately|Evaluate efficacy in terms of Minimal Residual Disease (MRD) negative Complete Remission conversion by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan after completing consolidation treatment with teclistamab., MRD assessed by FDG PET-CT scan using Deauville score., 18 months approximately|Evaluate efficacy in terms of Sustained Minimal Residual Disease (MRD) negative Complete Remission rate by next generation sequencing ( NGS)., MRD measured by NGS with a sensitivity level of 10-6., 42 months approximately|Evaluate efficacy in terms of Sustained Minimal Residual Disease (MRD) negative Complete Remission rate by Fluorodeoxyglucose Positron Emission Tomography-Computerized Tomography (FDG PET-CT) scan., MRD assessed by FDG PET-CT scan using Deauville score., 42 months approximately|To assess Overall Response Rate (ORR), ORR is defined as proportion of patients achieveing documentation of a response (Partial Response or better) from the first dose of study drug on treatment. Response to treatment is defined according to the International Myeloma Working Group (IMWG) criteria., 42 months approximately|To assess Overall Survival (OS)., OS is defined as the time from the date of first dose of study drug to the date of the subject's death. If the subject is alive or the vital status is unknown, then the subject's data will be censored at the date the subject was last known to be alive. OS is measured in months., 42 months approximately|To assess Progression free Survival (PFS)., PFS is defined as the time from the date of first dose of study drug to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. For subjects who have not progressed and are alive, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy. PFS is measured in months., 42 months approximately|To assess Duration of Response ( DoR)., DoR is the date of initial documentation of a response (Partial Response or better) to the date of first documented evidence of progressive disease, as defined in the International Myeloma Working Group (IMWG) criteria. Relapse from complete response is not considered as disease progression. For subjects who have not progressed, data will be censored at the last disease evaluation before the start of any subsequent anti-myeloma therapy. DoR is measured in months., 42 months approximately|To assess Time to Next anti-myeloma Treatment (TNT)., TNT is defined as the time between date of first dose of study drug and the first dose of the next treatment received. TNT is measured in months., 42 months approximately|To assess the safety and tolerability of the treatment described in the protocol., Incidence of treatment-emergent adverse events. AE monitoring according to NCI-CTCAE Version 5.0), grading of CRS and ICANS will be assessed based on ASTCT guidelines., 42 months approximately|To assess quality of life on the treatment described in the protocol., Quality of life in general is assessed using PRO questionnaire, such as EORTC QLQ-C30., 42 months approximately|To assess incidence of participant -recorded side effects on the treatment described in the protocol., Participant - recorded side effects are assessed using PRO questionnaire, such as PRO-CTCAE., 42 months approximately
Other Outcome Measures: To capture specific proteomic signatures from MRD positive and negative patients by mass-spectrometry based proteomic profiling., 42 months approximately