Multiple myeloma
Conditions
Brief summary
MRD-CR negativity (10^-5) with complete response at Month 12
Detailed description
Progression-free survival (PFS), Complete response (CR) or better, PFS2 (progression‑free survival to second disease progression or death), Overall survival (OS), Incidence and severity of AEs, Incidences of SAEs, MRD negativity (10^-5), Sustained MRD negativity (10^-5) for at least 12 months, • Time to worsening of symptoms • Mean change from baseline in the EORTC QLQ-C30 global health status and functional scale scores (including MY-20)
Interventions
DRUGJNJ-64407564
DRUGDARZALEX 1800 mg solution for injection
DRUGRevlimid 15 mg hard capsules
DRUGteclistamab
Sponsors
Polish Myeloma Consortium
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD-CR negativity (10^-5) with complete response at Month 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), Complete response (CR) or better, PFS2 (progression‑free survival to second disease progression or death), Overall survival (OS), Incidence and severity of AEs, Incidences of SAEs, MRD negativity (10^-5), Sustained MRD negativity (10^-5) for at least 12 months, • Time to worsening of symptoms • Mean change from baseline in the EORTC QLQ-C30 global health status and functional scale scores (including MY-20) | — |
Outcome results
None listed