CI

At a glance

ClinicalIndex Comparison Record
Phase 3Recruiting· 411 target
Drug / intervention
Iberdomide +2 moredrug
Likely dose
Iberdomide 0.75 mgfrom record
Key inclusion· 8
  • ✓Prior inclusion and treatment within GMMG-HD8/DSMM XIX trial OR specific quadruplet induction therapy
  • ✓Proteasome inhibitor and IMiD with anti-CD38 monoclonal antibody (isatuximab or daratumumab)
  • ✓Induction and consolidation therapy total 4-6 cycles, max 2 consolidation cycles post HDM/ASCT
  • ✓Received at least one cycle of high dose melphalan and ASCT
Key exclusion· 20
  • ✕Gastrointestinal disease significantly altering iberdomide absorption
  • ✕Known hypersensitivity to study therapy components not amenable to premedication
  • ✕History of serious allergic reaction to another IMiD
  • ✕Currently treated with strong CYP3A4/5 inhibitors or inducers

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06216158
NCT06216158Phase 3RecruitingHigh MomentumUpdated 4mo ago
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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

University of Heidelberg Medical Center·interventional·Posted Jan 22, 2024·Updated Feb 2, 2026

In Brief

A Phase 3 clinical trial evaluating Iberdomide, Isatuximab, and 1 other intervention for Multiple Myeloma. Currently recruiting, targeting 411 participants across 69 sites in 2 countries.

Signals

Enrolling ahead of pace

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Myeloma
CountriesAustria, Germany
CollaboratorsKKS Netzwerk, Wuerzburg University Hospital, Sanofi, Bristol-Myers Squibb

Timeline

Phase 3Recruiting
202420252026202720282029
First PostedJan 22, 2024
Enrollment StartApr 5, 2024
Primary CompletionDec 1, 2028
Study CompletionJun 1, 2029
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 2.4 years agoPrimary completion in 2.4 years

Interventions

Iberdomidedrug

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

Isatuximabdrug

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

Dexamethasonedrug

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