Multiple Myeloma
Conditions
Brief summary
MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of talquetamab and 6 cycles of teclistamab consolidation therapy
Detailed description
MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of Dara-VRd induction, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of talquetamab, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of teclistamab, Proportion of participants with persistent MRD negative disease at month 12 and 24 after completing treatment with teclistamab, by NGS (sensitivity level of 10-6), and FDG PET-CT scan, Overall Response Rate (ORR), Overall Survival (OS), Progression free survival (PFS), Duration of response (DOR), Time to next anti-myeloma treatment (TTNT), TEAEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0), Incidence of participant-recorded side effects (during the treatment with talquetamab and teclistamab) Impact of treatment on (physical, social, cognitive, emotional, overall) quality of life, MRD status 100 days after starting of standard of care treatment
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of talquetamab and 6 cycles of teclistamab consolidation therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD measured by NGS (sensitivity level of 10-6) and FDG PET-CT scan using the Deauville score and CR evaluated per IMWG 2016 response criteria after 6 cycles of Dara-VRd induction, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of talquetamab, Percentage of participants converting from positive MRD to negative MRD (sensitivity level of 10-6) after 6 cycles of teclistamab, Proportion of participants with persistent MRD negative disease at month 12 and 24 after completing treatment with teclistamab, by NGS (sensitivity level of 10-6), and FDG PET-CT scan, Overall Response Rate (ORR), Overall Survival (OS), Progression free survival (PFS), Duration of response (DOR), Time to next anti-myeloma treatment (TTNT), TEAEs according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE, Version 5.0), Incidence of participant-recorded side effects (during the treatment with talquetamab and t | — |
Countries
Denmark, Estonia, Norway