A Phase 3, Two-Stage, Randomized, Multicenter, Open-Label Study Comparing Mezigdomide (CC-92480), Bortezomib And Dexamethasone (MeziVd) Versus Pomalidomide, Bortezomib And Dexamethasone (PVd) In Subjects With Relapsed Or Refractory Multiple Myeloma (RRMM): Successor-1

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509859-13-00

Acronym

CA057-001

Enrollment

322

Registered

2024-06-18

Start date

2022-11-09

Completion date

Unknown

Last updated

2025-09-25

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)

Detailed description

Recommended mezigdomide dose, Pharmacokinetics, Overall Survival (OS), Overall Response Rate (OR), Complete Response Rate (CR) or better, Very Good Partial Response Rate (VGPR) or better, Time to Response (TTR), Duration of Response (DOR), Time to Progression (TTP), Time to Next Treatment (TTNT), Progression-free survival 2 (PFS-2), Minimal residual disease (MRD) negativity, Safety, Health Related Quality of Life (HRQoL) Evaluation

Interventions

DRUGCC-92480

DRUGImnovid 1 mg hard capsules

DRUGDexamethason-ratiopharm® 4 mg Tabletten

DRUGDexamethason 4 mg JENAPHARM®

DRUGImnovid 2 mg hard capsules

DRUGDexamethason CF 20 mg/ml

DRUGinjectievloeistof

DRUGVELCADE 1 mg powder for solution for injection

DRUGDEXAMETHASONE

DRUGImnovid 3 mg hard capsules

DRUGDexamethason 4 mg GALEN®

DRUGImnovid 4 mg hard capsules

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free Survival (PFS)	—

Secondary

Measure	Time frame
Recommended mezigdomide dose, Pharmacokinetics, Overall Survival (OS), Overall Response Rate (OR), Complete Response Rate (CR) or better, Very Good Partial Response Rate (VGPR) or better, Time to Response (TTR), Duration of Response (DOR), Time to Progression (TTP), Time to Next Treatment (TTNT), Progression-free survival 2 (PFS-2), Minimal residual disease (MRD) negativity, Safety, Health Related Quality of Life (HRQoL) Evaluation	—

Measure

Time frame

—

Countries

Austria, Belgium, Czechia, Finland, France, Germany, Greece, Ireland, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

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