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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04975997 | Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) | PHASE3 | ACTIVE NOT_RECRUITING | 939 | — | — | Jun 23, 2022 | Jun 25, 2032 | Apr 3, 2026 | 259 | United States, Argentina +29 |
| NCT03000452 | A Study to Determine the Efficacy of the Combination of Daratumumab (DARA) Plus Durvalumab (DURVA) (D2) in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) | PHASE2 | COMPLETED | 18 | — | — | Mar 14, 2017 | Dec 4, 2017 | Oct 16, 2018 | 25 | United States, Austria +4 |
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of progression free survival (PFS).
To compare the efficacy of iberdomide (also known as BMS-986382), daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM) in terms of minimal residual disease (MRD) negative complete response (CR) at any time.
Objective response is defined as a best overall response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on the investigator assessment: sCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
| Arm | Type | Description |
|---|---|---|
| Daratumumab in combination with Iberdomide and dexamethasone - Dose 1 | EXPERIMENTAL | Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone. |
| Daratumumab in combination with Iberdomide and dexamethasone - Dose 2 | EXPERIMENTAL | - |
| Daratumumab in combination with Iberdomide and dexamethasone - Dose 3 | EXPERIMENTAL | - |
| Daratumumab in combination with dexamethasone and bortezomib | ACTIVE_COMPARATOR | Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone |
| Administration of Daratumumab (DARA) plus Durvalumab (DURVA) | EXPERIMENTAL | Subjects will also receive IV DURVA at 1500 mg on Day 2 (Cycle 1) and on Day 1 (Cycles ≥ 2) of each 28-day treatment cycle. Subjects will receive intravenous (IV) DARA at 16 mg/kg on the same dosing schedule (weekly \[QW\], every 2 weeks \[Q2W\], or every 4 weeks \[Q4W\] of each 28-day treatment cycle) received during their last prior therapy containing DARA at the time of DARA progression |
| Name | Type | Description |
|---|---|---|
| Dexamethasone | DRUG | Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle |
| Daratumumab | DRUG | Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7+ of a 28-day cycle |
| Bortezomib | DRUG | Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles. |
| Iberdomide | DRUG | Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle |
| DURVALUMAB | DRUG | DURVALUMAB |
Inclusion Criteria * Documented diagnosis of multiple myeloma (MM) and measurable disease. * Received 1 to 2 prior lines of anti-myeloma therapy. * Must have documented disease progression during or after their last anti-myeloma regimen. * Eastern Cooperative Oncology Group (ECOG) performance statu...