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A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapy in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506668-15-00
Acronym
M22-574
Enrollment
147
Registered
2024-05-24
Start date
2024-06-17
Completion date
Unknown
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or Refractory Multiple Myeloma (RRMM)

Brief summary

Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment, Overall Response Rate (ORR) per IMWG (2016) response criteria (defined as PR + VGPR + CR + sCR) per IRC assessment

Detailed description

Overall Survival (OS), Rate of ≥VGPR per IRC assessment, Rate of ≥CR per IRC assessment, Rate of MRD negativity with ≥CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by NGS Adaptive Clonoseq at 10- 5 threshold, Change from baseline at 6 months in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20, Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30, Time to response (TTR) per IRC assessment, Duration of response (DoR) per IRC assessment, Time to Disease Progression (TTP) per IRC assessment, Time to Next Therapy (TTNT), Event free survival (EFS), Patient Reported Outcomes (PROs): Change from baseline in the score of remaining scales and items of the EORTC QLQ-C30 and EORTC QLQ-MY20, PROMIS Fatigue SF 7a, EQ-5D-5L, PGIS; scores/frequencies of PGIS, PGIC and select items of the PRO-CTCAE, Skeletal-related event (SREs), defined as presence of any of the following events: - spinal cord compression; - pathologic fracture; - surgery to bone; - radiation to bone

Interventions

DRUGDEXAMETHASONE
DRUGPOMALIDOMIDE
DRUGBORTEZOMIB
DRUGPARACETAMOL
DRUGSELINEXOR
DRUGDIPHENHYDRAMINE
DRUGCARFILZOMIB
DRUGELOTUZUMAB

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression Free Survival (PFS) with Progressive Disease (PD) assessed according to the IMWG (2016) response criteria, per IRC assessment, Overall Response Rate (ORR) per IMWG (2016) response criteria (defined as PR + VGPR + CR + sCR) per IRC assessment

Secondary

MeasureTime frame
Overall Survival (OS), Rate of ≥VGPR per IRC assessment, Rate of ≥CR per IRC assessment, Rate of MRD negativity with ≥CR, defined as achievement of CR or better by IMWG (2016) response criteria (per IRC assessment) and MRD negative status as assessed by NGS Adaptive Clonoseq at 10- 5 threshold, Change from baseline at 6 months in disease symptoms as measured by the disease symptoms domain of the EORTC QLQ-MY20, Change from baseline at 6 months in physical functioning as measured by the physical functioning domain of the EORTC QLQ-C30, Time to response (TTR) per IRC assessment, Duration of response (DoR) per IRC assessment, Time to Disease Progression (TTP) per IRC assessment, Time to Next Therapy (TTNT), Event free survival (EFS), Patient Reported Outcomes (PROs): Change from baseline in the score of remaining scales and items of the EORTC QLQ-C30 and EORTC QLQ-MY20, PROMIS Fatigue SF 7a, EQ-5D-5L, PGIS; scores/frequencies of PGIS, PGIC and select items of the PRO-CTCAE, Skeletal-relat

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Poland, Portugal, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026