A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexamethasone induction therapy with either intravenous or subcutaneous isatuximab in transplant-eligible patients with newly diagnosed multiple myeloma (GMMG HD8/ DSMM XIX)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516300-41-00

Acronym

GMMG-HD8/DSMM XIX

Enrollment

514

Registered

2024-11-04

Start date

2023-03-07

Completion date

Unknown

Last updated

2025-08-19

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 VGPR or better (according to standard IMWG response criteria), defined as proportion of patients with at least VGPR after induction therapy

Detailed description

PRO outcomes score assessed by CTSQ (subdomain “satisfaction with therapy”) for SC vs. IV isatuximab application on induction therapy, Rates of NGS-MRD negativity (sensitivity 10^-5, from BMA) after induction therapy

Interventions

DRUGIsatuximab

DRUGLenalidomid HEXAL 25 mg Hartkapseln

DRUGLenalidomid HEXAL 10 mg Hartkapseln

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGLenalidomid HEXAL 15 mg Hartkapseln

DRUGLenalidomid HEXAL 5 mg Hartkapseln

DRUGDEXAMETHASONE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Rates of VGPR or better (according to standard IMWG response criteria), defined as proportion of patients with at least VGPR after induction therapy	—

Secondary

Measure	Time frame
PRO outcomes score assessed by CTSQ (subdomain “satisfaction with therapy”) for SC vs. IV isatuximab application on induction therapy, Rates of NGS-MRD negativity (sensitivity 10^-5, from BMA) after induction therapy	—

Countries

Austria, Germany

Outcome results

None listed

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