LINKER-MM5Linvoseltamab y Carfilzomib para Mieloma Múltiple Recurrente/Refractario

Linvoseltamab

Linvoseltamab

Carfilzomib

Linvoseltamab

Linvoseltamab

Carfilzomib

Carfilzomib

Daratumumab

Dexamethasone

Pomalidomide

Bortezomib

Severity of AESIs

Severity of TEAEs

Occurrence of Adverse Events of Special Interest (AESI)

Progression-Free Survival (PFS) per IMWG response criteria as determined by BIRC

Occurrence of Serious Adverse Events (SAEs)

Severity of SAEs

Minimal Residual Disease (MRD)-negative Complete Response (CR)

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Achievement of Partial Response (PR) or better per IMWG response criteria as determined by BIRC

Achievement of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by BIRC

Achievement of CR or better per IMWG response criteria as determined by BIRC

Duration Of Response (DOR) as per IMWG response criteria

Occurrence of grade ≥2 Cytokine Release Syndrome (CRS)

Timing of grade ≥2 CRS

Overall Survival (OS)

Time To Progression (TTP) as per IMWG response criteria

MRD-negative CR criteria at any time

Time To Next Treatment (TTNT)

Second PFS

Time to PR IMWG response category

Time to VGPR IMWG response category

Time to CR IMWG response category

Time to stringent Complete Response (sCR) IMWG response category

Sustained MRD-negative CR

Duration of MRD-negative CR

Occurrence of TEAEs

Severity of TEAEs

Occurrence of AESIs

Severity of AESIs

Occurrence of SAEs

Severity of SAEs

Concentrations of linvoseltamab in serum over time

Incidence of Antidrug Antibodies (ADAs) to linvoseltamab

Magnitude of ADAs to linvoseltamab

Concentrations total soluble B-cell Maturation Antigen (sBCMA) in serum over time

Change from baseline in Global Health Status (GHS)/Quality of Life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Change from baseline in Physical Functioning (PF), per EORTC QLQ-C30

Change from baseline in Role Functioning (RF), per EORTC QLQ-C30

Change from baseline in pain, per EORTC QLQ-C30

Change from baseline in fatigue, per EORTC QLQ-C30

Change in patient reported Disease Symptoms (DS) per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20])

Change in patient reported Treatment Side Effects (TSE) per EORTC QLQ-MY20

Change in patient-reported health state per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) Visual Analogue Scale (VAS)

Change in patient-reported overall impact of treatment per Functional Assessment of Chronic Illness Therapy (FACIT) item GP5