Improving MRD Negativity Rates in Newly Diagnosed Multiple Myeloma Patients: a Response-adaptive Approach of Consolidation With One or Two Bispecific T-cell Engagers Against GPRC5D or BCMA
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Summary
Multiple myeloma is characterized by a pattern of recurrent relapse and remains an incurable malignancy. Participants with minimal residual disease (MRD) after front line therapy with induction with or without transplant have worse prognosis than those with MRD negative disease. Bispecific T-cell-based immunotherapies have the potential to promote further reduction of malignant plasma cells thus improving rates of MRD negativity and improve patient outcomes. In this study, participants who are MRD positive after front line therapy will receive consolidation with GPRC5D-targeted bispecific talquetamab. We will test MRD negative conversion and if MRD negativity was not achieved, the participant will switch to a different target using the B-cell maturation antigen TCE, teclistamab. Consolidation will be continued for up to 1 year in participants who have achieved MRD negativity.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria To qualify for participation in this study, an individual must satisfy each of the following criteria: 1. Provision of signed and dated ICF. 2. Stated willingness to comply with all study procedures and availability for the duration of the study. 3. Male or female aged 18 years or older. 4. Newly diagnosed multiple myeloma participants who are transplant eligible and have completed at least four cycles of quadruplet, anti-CD38 antibody-based induction and have received HDM ASCT within 60-120 days. If consolidation with the same induction regimen is used post ASCT, enrolmen…
Interventions
- DrugTalquetamab
Talquetamab is a GPRC5DxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.
- DrugTeclistamab
Teclistamab is a BCMAxCD3 bispecific antibody. It is supplied as a sterile, preservative-free solution for subcutaneous administration.
Locations (2)
- Yale UniversityNew Haven, Connecticut
- Wilmot Cancer Center, Clinical Trial Office of the University of Rochester Medical CenterRochester, New York