Multiple Myeloma
Conditions
Brief summary
PFS, Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5
Detailed description
Overall response (PR or better) status and CR or better status, Overall MRD-negative CR with a sensitivity of at least 10-5, Time to subsequent antimyeloma therapy, PFS on next-line therapy (PFS2), Incidence, severity, and type of AEs, clinical laboratory results, and other safety parameters, OS, PK and pharmacodynamic markers by protein, DNA, or RNA analyses, including but not limited to, systemic inflammatory cytokine concentrations, markers of CAR-T cell expansion (proliferation) and persistence via monitoring of cilta-cel-positive cellular concentrations, and cilta-cel transgene levels, Mean change from baseline in the EORTC-QLQ-C30, MySIm-Q, and EQ-5D-5L subscale scores and the PROCTCAE items, Time to improvement or worsening of symptoms, functioning, and overall well-being, Improvement or worsening in the EORTC-QLQ- C30 and MySIm-Q subscale scores using the PGIS to calculate the meaningful change threshold, Presence of RCL
Interventions
DRUGtabletten
DRUGVELCADE 3.5 mg powder for solution for injection
DRUGDARZALEX 1800 mg solution for injection
Sponsors
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, Sustained MRD-negative CR, defined as MRD-negative CR for at a minimum 12 months duration, with MRD status determined by NGS with a sensitivity of at least 10-5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response (PR or better) status and CR or better status, Overall MRD-negative CR with a sensitivity of at least 10-5, Time to subsequent antimyeloma therapy, PFS on next-line therapy (PFS2), Incidence, severity, and type of AEs, clinical laboratory results, and other safety parameters, OS, PK and pharmacodynamic markers by protein, DNA, or RNA analyses, including but not limited to, systemic inflammatory cytokine concentrations, markers of CAR-T cell expansion (proliferation) and persistence via monitoring of cilta-cel-positive cellular concentrations, and cilta-cel transgene levels, Mean change from baseline in the EORTC-QLQ-C30, MySIm-Q, and EQ-5D-5L subscale scores and the PROCTCAE items, Time to improvement or worsening of symptoms, functioning, and overall well-being, Improvement or worsening in the EORTC-QLQ- C30 and MySIm-Q subscale scores using the PGIS to calculate the meaningful change threshold, Presence of RCL | — |
Countries
Belgium, Czechia, France, Germany, Greece, Netherlands, Norway, Spain, Sweden
Outcome results
None listed