Multiple myeloma (RRMM)
Conditions
Brief summary
PFS at 12 months (12 cycles)
Detailed description
MRD negative with CR after 12 cycles, MRD negative with CR after 24 cycles, PFS overall, ORR (PR or better), VGPR or better, CR or better, Duration of response, Time to response, OS, Incidence and severity of AEs, Grade 3 or 4 infections, infection rate, serious AEs, AE Grade5/deaths and reasons, AEs causing treatment withdrawal or hospitalization and laboratory results, Change from baseline in symptoms, functioning, and overall HRQoL where baseline is defined as the latest measurement before the first dose of study treatment., Time to worsening in symptoms, functioning, and overall HRQoL.
Interventions
DRUGteclistamab
DRUGImnovid 2 mg hard capsules
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS at 12 months (12 cycles) | — |
Secondary
| Measure | Time frame |
|---|---|
| MRD negative with CR after 12 cycles, MRD negative with CR after 24 cycles, PFS overall, ORR (PR or better), VGPR or better, CR or better, Duration of response, Time to response, OS, Incidence and severity of AEs, Grade 3 or 4 infections, infection rate, serious AEs, AE Grade5/deaths and reasons, AEs causing treatment withdrawal or hospitalization and laboratory results, Change from baseline in symptoms, functioning, and overall HRQoL where baseline is defined as the latest measurement before the first dose of study treatment., Time to worsening in symptoms, functioning, and overall HRQoL. | — |
Outcome results
None listed