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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03732703 | Myeloma-Developing Regimens Using Genomics (MyDRUG) | PHASE1 | COMPLETED | 103 | — | — | Apr 1, 2019 | Dec 31, 2024 | Feb 14, 2025 | 16 | United States |
• To evaluate the overall response rate (ORR) with targeted agents used in combination with backbone regimen ixazomib, pomalidomide and dexamethasone (IPd) in patients with an actionable genetic alteration per the International Myeloma Working Group \[IMWG\] consensus criteria (Kumar et al, 2016)
• To evaluate the ORR with agents used in combination with backbone (or IPd) regimen in patients with no actionable genetic alteration per IMWG consensus criteria (Kumar et al, 2016).
| Arm | Type | Description |
|---|---|---|
| Sub-Protocol A1 | EXPERIMENTAL | Patients with CDK activating alteration receive Abemaciclib in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Sub-Protocol B1 | EXPERIMENTAL | Patients with IDH2 activating mutation receive Enasidenib in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Sub-Protocol C1 | EXPERIMENTAL | Patients with the presence of RAF/RAS mutation receive Cobimetinib in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Sub-Protocol D1 | EXPERIMENTAL | Patients with presence of FGFR3 activating mutations receive Erdafitinib in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Sub-Protocol E1 | EXPERIMENTAL | Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long. |
| Sub-Protocol Y1 | EXPERIMENTAL | Patients with Non-Actionable Genetic Abnormality receive Daratumumab in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Sub-Protocol Y2 | EXPERIMENTAL | Patients with Non-Actionable Genetic Abnormality receive Belantamab mafodotin in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Sub-Protocol Y3 | EXPERIMENTAL | Patients with Non-Actionable Genetic Abnormality receive Selinexor in combination with ixazomib, pomalidomide and dexamethasone (IPd) |
| Name | Type | Description |
|---|---|---|
| Abemaciclib, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long. |
| Enasidenib, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Enasidenib and Dexamethasone for the first 2 cycles. Enasidenib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long. |
| Cobimetinib, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long. |
| Erdafitinib, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long. |
| Venetoclax, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long. |
| Daratumumab, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long. |
| Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long. |
| Selinexor, dexamethasone, ixazomib, pomalidomide | DRUG | Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long. |
Inclusion Criteria: * Willing to be registered into the pomalidomide (POMALYST®) Risk Evaluation and Mitigation Strategy (REMS®) program * Enrolled in the MMRF002 Molecular Profiling Protocol (NCT02884102) with report less than 120 days old * Disease free of prior malignancies for ≥ 3 years with ex...