MedTrace Logo

Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma

NCT06216158 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2026-02-02

No results posted yet for this study

Summary

The goal of this clinical trial is to compare a maintenance therapy consisting of iberdomide and isatuximab with an iberdomide-only regimen. The trial is the subsequent maintenance therapy to GMMG-HD8/DSMM XIX trial for patients with newly-diagnosed multiple myeloma. Patients with newly-diagnosed multiple myeloma who underwent a similar quadruplet induction/consolidation therapy regimen followed by at least one ASCT can also be recruited. The main question it aims to answer is:

• Will the addition of isatuximab lead to decreased amounts of measurable myeloma cells in the bone marrow after two years?

Conditions

Interventions

DRUG

Dexamethasone

Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22)

DRUG

Iberdomide

Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle)

DRUG

Isatuximab

Isatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1)

Sponsors & Collaborators

  • KKS Netzwerk

    collaborator NETWORK

  • Wuerzburg University Hospital

    collaborator OTHER

  • Sanofi

    collaborator INDUSTRY

  • Bristol-Myers Squibb

    collaborator INDUSTRY

  • University of Heidelberg Medical Center

    lead OTHER

Principal Investigators

  • Hartmut Goldschmidt, Prof. · University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-05
Primary Completion
2028-12-31
Completion
2029-06-30

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT06216158 on ClinicalTrials.gov