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Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients.

NCT05527340 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-05-08

No results posted yet for this study

Summary

This is a multicenter, phase II, national, and open-label study to evaluate the efficacy and safety of two different combinations, iberdomide-dexamethasone (IBERDEX) and iberdomide-dexamethasone in combination with daratumumab (IBERDARADEX) in transplant ineligible newly diagnosed multiple myeloma (NDMM) patients. It will be ensured that at least 30% of the patients are frail in order to evaluate the feasibility of these combinations in this special population.

Patients will receive treatment with either iberdomide + dexamethasone (IBERDEX) or iberdomide + daratumumab + dexamethasone (IBERDARADEX), until unacceptable toxicity, disease progression, patient withdrawal, loss to follow-up, end of study or death, whichever comes first. This is not a randomized trial so eligible patients will be sequentially allocated to receive iberdomide-dexamethasone or iberdomide-dexamethasone plus daratumumab.

Conditions

Interventions

DRUG

Iberdomide

Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO)

DRUG

Dexamethasone

Dexamethasone 40 mg (PO) (or 20 mg (PO) if patient ≥ 75 years old) should be administered on the days 1, 8, 15 and 22 of every 4-week cycle.

DRUG

Daratumumab

Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days).

Sponsors & Collaborators

  • Celgene

    collaborator INDUSTRY

  • Janssen-Cilag, S.A.

    collaborator INDUSTRY

  • LIDESEC SL

    collaborator UNKNOWN

  • PETHEMA Foundation

    lead OTHER

Principal Investigators

  • María Victoria Mateos Manteca · University of Salamanca

  • Verónica González de la Calle · University of Salamanca

  • Jesús San Miguel Izquierdo · Clínica Universidad de Navarra

  • Juan José Lahuerta Palacios · Hospital Universitario 12 de Octubre

  • Joan Bladé Creixenti · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-15
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05527340 on ClinicalTrials.gov