A randomized phase III trial assessing iberdomide versus iberdomide plus isatuximab maintenance therapy post autologous hematopoietic stem-cell transplantation in patients with newly diagnosed multiple myeloma (GMMG-HD9/DSMM XVIII-trial)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507402-13-00

Acronym

GMMG-HD9/DSMM XVIII

Enrollment

451

Registered

2024-02-16

Start date

2024-04-03

Completion date

Unknown

Last updated

2025-07-09

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

Conditions

Multiple myeloma

Brief summary

Rates of NGF-MRD negativity (sensitivity 2x10-6, from bone marrow aspirate [BMA]) after two years of maintenance therapy.

Detailed description

PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.

Interventions

DRUGDexamethason TAD® 20 mg Tabletten

DRUGIberdomide

DRUGIsatuximab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rates of NGF-MRD negativity (sensitivity 2x10-6, from bone marrow aspirate [BMA]) after two years of maintenance therapy.	—

Secondary

Measure	Time frame
PFS, defined as time from randomization to disease progression or death from any cause, whichever occurs first.	—

Countries

Austria, Germany

Outcome results

None listed

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