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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05827016 | A Study to Compare Iberdomide Maintenance Versus Lenalidomide Maintenance Therapy Following Autologous Stem Cell Transplant in Participants With Newly Diagnosed Multiple Myeloma | PHASE3 | RECRUITING | 1,216 | — | — | Jun 22, 2023 | Jan 1, 2036 | Mar 13, 2026 | 285 | United States, Argentina +33 |
| NCT05527340 | Iberdomide-dexamethasone Alone or in Combination With Standard MM Treatment Regimens in Transplant Ineligible Newly Diagnosed Patients. | PHASE2 | ACTIVE NOT_RECRUITING | 140 | — | — | Dec 15, 2022 | Dec 1, 2029 | May 8, 2026 | 9 | Spain |
| NCT05434689 | COMbination Regimens in MM Post AHCT to elimiNate MRD Utilizing IbERdomide | PHASE1 | ACTIVE NOT_RECRUITING | 80 | — | — | Jan 18, 2023 | Oct 1, 2026 | Apr 15, 2026 | 6 | United States |
The percentage of participants with a confirmed partial response (PR) or better (PR, Very good partial response (VGPR), Complete response (CR), stringent complete response (sCR)).Response rates will be monitored monthly, but the study will report the % of patients achieving CR rate at month 12, 18, 24 and yearly thereafter.
The percentage of participants with a confirmed complete response (CR) or better (stringent complete response (CR, sCR).
Proportion of patients in each regimen who develop dose limiting toxicity
Rate MRD conversion ( to \<10-5 MM-associated molecules) at completion of consolidation therapy. Patients who are not assessed for MRD at the completion of consolidation (due to any reason, including death, withdrawal from study, loss to follow-up, missed assessment, etc) will be considered as not having achieved MRD conversion.
| Arm | Type | Description |
|---|---|---|
| Arm A1: Iberdomide Dose 1 | EXPERIMENTAL | - |
| Arm A2: Iberdomide Dose 2 | EXPERIMENTAL | - |
| Arm A3: Iberdomide Dose 3 | EXPERIMENTAL | - |
| Arm B: Lenalidomide | ACTIVE_COMPARATOR | - |
| iberdomide + dexamethasone (IBERDEX) | EXPERIMENTAL | IBERDEX * Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, orally (PO). * Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO. |
| iberdomide + daratumumab + dexamethasone (IBERDARADEX) | EXPERIMENTAL | IBERDARADEX * Iberdomide on days 1 to 21 at 1.6 mg, every 4 weeks, PO. * Dexamethasone will be given on days 1, 8, 15, and 22 at 40 mg (patients aged ≥ 75 years: 20 mg), every 4 weeks, PO. * Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days). |
| Iberdomide, Daratumumab and Dexamethasone (Regimen A) | EXPERIMENTAL | Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) |
| Iberdomide, Carfilzomib, Daratumumab and Dexamethasone (Regimen B) | EXPERIMENTAL | Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) Carfilzomib dosed intravenously dosed according to cohort assignment on days 1, 8, 15 (Consistent with standard practice, the very first dose of carfilzomib (cycle 1 day 1) must be 20 mg/m\^2). |
| Name | Type | Description |
|---|---|---|
| Iberdomide | DRUG | Specified dose on specified days |
| Lenalidomide | DRUG | Specified dose on specified days |
| Dexamethasone | DRUG | Dexamethasone 40 mg (PO) (or 20 mg (PO) if patient ≥ 75 years old) should be administered on the days 1, 8, 15 and 22 of every 4-week cycle. |
| Daratumumab | DRUG | Daratumumab will be given at 1800 mg, every 4 weeks, subcutaneously (SC). Cycles 1 and 2 (C1 and C2): Days 1, 8, 15, and 22 C3-6: Days 1 and 15 From C7 onwards: Day 1 of each cycle Cycles will be of 4 weeks of duration (28 days). |
| Carfilzomib | DRUG | Second generation proteasome inhibitor with activity in multiple myeloma |
Inclusion Criteria * Confirmed diagnosis of symptomatic multiple myeloma (MM). * Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2. * Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) \[eg, bortezomib ...