PI-based combination regimen for the treatment of first relapse of MM
| Name of the study . | Study design/regimen . | Patient group . | Median prior lines of therapy (range) . | Response ORR ≥ VGPR . | Median PFS (months) . | Median OS (months) . | Toxicity . | |
|---|---|---|---|---|---|---|---|---|
| CASTOR16,17 | Phase 3 randomized | Dara-Vd | 2 (1-9) | 82.9% | 59.2 | 16.7 | NR | Neutropenia, thrombocytopenia, infusion-related reactions |
| Vd | 63.2%; P < .001 | 29.1%; P < .001 | 7.1 P < .0001 | |||||
| BOSTON22 | Phase 3 randomized | Seli-Vd | 2 (1-3) | 76.4% | 44.6% | 13.9 (11.73-NE) | NR | Thrombocytopenia, anemia, fatigue, pneumonia. Peripheral neuropathy significantly lower in the selinexor group. |
| Vd | 62.3%; P = .0012 | 32.4%; P = .0082 | 9.46 (8.11-10.78) P = .0075 | 25 (23.5-NE) P = .18 | ||||
| CANDOR24,25 | Phase 3 randomized | Dara-Kd | 2 (1-5) | 84% | 69% | 28.6 (22.7-NE) | NA | Thrombocytopenia, diarrhea, URTI, pneumonia, fatigue, viral infection, PN |
| Kd | 75%, P = 0.008 | 49% P = NA | 15.2 (11.1-19.9) P < .0001 | NA | ||||
| IKEMA27 | Phase 3 randomized | Isa-Kd | 2 (1-2) | 87% | 73% | NR | NR | Diarrhea, URTI, neutropenia, thrombocytopenia |
| Kd | 83%, P = .19 | 56%, P = .001 | 19.15 (15.77-NR), P = .0007 | NR | ||||
| MYX.1/MCRN-00343 | Phase 2 study | KCd | 2 (1-3) | 85% | 68% | 17.2 (13.4–21.5) | 27.4 (22.1 – NE) | Anemia, thrombocytopenia, neutropenia, infection, cardiovascular events, TMA |
| Name of the study . | Study design/regimen . | Patient group . | Median prior lines of therapy (range) . | Response ORR ≥ VGPR . | Median PFS (months) . | Median OS (months) . | Toxicity . | |
|---|---|---|---|---|---|---|---|---|
| CASTOR16,17 | Phase 3 randomized | Dara-Vd | 2 (1-9) | 82.9% | 59.2 | 16.7 | NR | Neutropenia, thrombocytopenia, infusion-related reactions |
| Vd | 63.2%; P < .001 | 29.1%; P < .001 | 7.1 P < .0001 | |||||
| BOSTON22 | Phase 3 randomized | Seli-Vd | 2 (1-3) | 76.4% | 44.6% | 13.9 (11.73-NE) | NR | Thrombocytopenia, anemia, fatigue, pneumonia. Peripheral neuropathy significantly lower in the selinexor group. |
| Vd | 62.3%; P = .0012 | 32.4%; P = .0082 | 9.46 (8.11-10.78) P = .0075 | 25 (23.5-NE) P = .18 | ||||
| CANDOR24,25 | Phase 3 randomized | Dara-Kd | 2 (1-5) | 84% | 69% | 28.6 (22.7-NE) | NA | Thrombocytopenia, diarrhea, URTI, pneumonia, fatigue, viral infection, PN |
| Kd | 75%, P = 0.008 | 49% P = NA | 15.2 (11.1-19.9) P < .0001 | NA | ||||
| IKEMA27 | Phase 3 randomized | Isa-Kd | 2 (1-2) | 87% | 73% | NR | NR | Diarrhea, URTI, neutropenia, thrombocytopenia |
| Kd | 83%, P = .19 | 56%, P = .001 | 19.15 (15.77-NR), P = .0007 | NR | ||||
| MYX.1/MCRN-00343 | Phase 2 study | KCd | 2 (1-3) | 85% | 68% | 17.2 (13.4–21.5) | 27.4 (22.1 – NE) | Anemia, thrombocytopenia, neutropenia, infection, cardiovascular events, TMA |
Dara, daratumumab; Isa, isatuximab; KCd, carfilzomib-cyclophosphamide-dexamethasone; Kd, carfilzomib-dexamethasone; NA, not available; NE, not evaluable; Seli, selinexor; Vd, velcade-dexamethasone; TMA, transplant thrombotic microangiopathy; URTI, upper respiratory tract infection.