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Multicenter, phase II, national and open-label study to evaluate Iberdomide-dexamethasone alone or in combination with standard MM treatment regimens in transplant ineligible newly diagnosed patients.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518870-15-00
Acronym
GEM-IBERDARAX
Enrollment
140
Registered
2024-11-20
Start date
2022-10-03
Completion date
Unknown
Last updated
2025-04-02

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

Conditions

Multiple Myeloma

Brief summary

Overall Response Rate (ORR) with the different responses categories and especially the Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR).

Detailed description

Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative by next-generation flow cytometry (NGF), PET/CT, and mass spectrometry. Analysis of MRD will be done by NGF according to International Myeloma Working Group (IMWG)., Progression-Free Survival (PFS), defined as the time from the start date of the study treatment until the earliest date of documented disease progression or death due to any cause., Overall Survival (OS), defined as the time from the start date of the study treatment until the date of death due to any cause., Determine the relative distribution and immunophenotype of myeloid suppresser cells, monocytes and macrophages, antigen presenting cells, NK, B and T cells from baseline onto treatment, remission and disease progression., EQ-5D/5L, QLQ-C30 and MY20 questionnaires, at baseline and at months 4, 8, 12, 18, and 24., - Incidence of deaths and primary cause of death. - Data for vital signs. - Incidence of adverse events (AEs). - Percentage of patients discontinuing therapy due to AEs. - Percentage of patients requiring dose modifications. - Changes in laboratory analytes from the hematology and blood chemistry panel., Time to Progression (TTP)., Time from start therapy to second disease progression or to the moment in which the third line of therapy starts: PFS2., Overall survival (OS).

Interventions

DRUGDARZALEX 1800 mg solution for injection
DRUGIberdomide

Sponsors

Fundacion PETHEMA
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Overall Response Rate (ORR) with the different responses categories and especially the Complete Response Rate (CRR), defined as the percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR).

Secondary

MeasureTime frame
Minimal Residual Disease (MRD) negativity rate is defined as the percentage of participants who are MRD negative by next-generation flow cytometry (NGF), PET/CT, and mass spectrometry. Analysis of MRD will be done by NGF according to International Myeloma Working Group (IMWG)., Progression-Free Survival (PFS), defined as the time from the start date of the study treatment until the earliest date of documented disease progression or death due to any cause., Overall Survival (OS), defined as the time from the start date of the study treatment until the date of death due to any cause., Determine the relative distribution and immunophenotype of myeloid suppresser cells, monocytes and macrophages, antigen presenting cells, NK, B and T cells from baseline onto treatment, remission and disease progression., EQ-5D/5L, QLQ-C30 and MY20 questionnaires, at baseline and at months 4, 8, 12, 18, and 24., - Incidence of deaths and primary cause of death. - Data for vital signs. - Incidence of adverse

Countries

Spain

Outcome results

None listed

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