Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06216158 | Iberdomide vs. Iberdomide Plus Isatuximab Maintenance Therapy Post ASCT in Newly Diagnosed Multiple Myeloma | PHASE3 | RECRUITING | 411 | — | — | Apr 5, 2024 | Jun 1, 2029 | Feb 2, 2026 | 69 | Austria, Germany |
The primary objective of this trial is to compare the two-year MRD negativity rate (sensitivity 2x10\^-6 via next-generation flow cytometry \[NGF\]; from bone marrow aspirate) when treated with iberdomide plus isatuximab, with the MRD negativity after treatment with iberdomide only.
| Arm | Type | Description |
|---|---|---|
| Arm A: Iberdomide | ACTIVE_COMPARATOR | 36 months of oral iberdomide administration; In cycle 1, dexamethasone is added as pre-medication |
| Arm B: Iberdomide plus isatuximab | EXPERIMENTAL | 36 months of oral iberdomide plus subcutaneous isatuximab administration; In cycle 1, dexamethasone is added as pre-medication |
| Name | Type | Description |
|---|---|---|
| Iberdomide | DRUG | Iberdomide p.o. (0.75 mg, day 1-21 of each 29-days cycle) |
| Isatuximab | DRUG | Isatuximab s.c. (1400 mg, cycle 1: day 1, 8, 15, 22; cycles 2-3: day 1 and 15; from C4: day 1) |
| Dexamethasone | DRUG | Dexamethasone p.o. or i.v. (20 mg, cycle 1 only: day 1, 8, 15, 22) |
Inclusion Criteria: * Prior inclusion and treatment within the GMMG-HD8 / DSMM XIX trial OR * Received a quadruplet induction/consolidation therapy that consists of a proteasome inhibitor (PI) and immunomodulatory drug (IMiD) \[e.g., bortezomib, thalidomide and dexamethasone, or bortezomib, lenalid...