A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects with Relapsed or Refractory Multiple Myeloma (RRMM) (EXCALIBER-RRMM)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510800-35-00

Acronym

CC-220-MM-002

Enrollment

394

Registered

2024-07-30

Start date

2022-06-17

Completion date

Unknown

Last updated

2026-01-08

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): Time from randomization to the first documentation of progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016 or death due to any cause, whichever occurs first., Minimal Residual Disease (MRD) negative CR at any time: Achievement of MRD negativity defined as less than 1 in 10^5 nucleated cells (by next generation flow cytometry) in bone marrow aspirate for subjects who achieve CR or better at any time after randomization

Detailed description

Recommended iberdomide dose for Stage 2, based on the totality of safety, efficacy, PK and PD data; In Stage 1, PK of iberdomide; Overall survival, Sustainability of MRD negativity; Overall response; Time to response; Duration of response; Time to progression; Time to next treatment; Progression-free survival 2; Safety; EORTC QLQ-C30 and EORTC QLQ-MY20

Interventions

DRUGIberdomide

DRUGBORTEZOMIB

DRUGDexamethasone 2mg Tablets

DRUGDexamethason-ratiopharm® 4 mg Tabletten

DRUGDARZALEX 1800 mg solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression-free survival (PFS): Time from randomization to the first documentation of progressive disease according to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma 2016 or death due to any cause, whichever occurs first., Minimal Residual Disease (MRD) negative CR at any time: Achievement of MRD negativity defined as less than 1 in 10^5 nucleated cells (by next generation flow cytometry) in bone marrow aspirate for subjects who achieve CR or better at any time after randomization	—

Measure

Time frame

—

Secondary

Measure	Time frame
Recommended iberdomide dose for Stage 2, based on the totality of safety, efficacy, PK and PD data; In Stage 1, PK of iberdomide; Overall survival, Sustainability of MRD negativity; Overall response; Time to response; Duration of response; Time to progression; Time to next treatment; Progression-free survival 2; Safety; EORTC QLQ-C30 and EORTC QLQ-MY20	—

Countries

Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Spain, Sweden

Outcome results

None listed

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