IMiD-based combination regimens for the treatment of first relapse of MM
| Name of the study . | Regimen trial . | Patient group . | Median prior lines of therapy (range) . | Response ORR ≥ VGPR . | Median PFS (months) . | Median OS (months) . | Toxicity . | |
|---|---|---|---|---|---|---|---|---|
| POLLUX8,9 | Phase 3 randomized | Dara-Rd | 1 (1-11) | 92.9% | 80.4% | 44.5 (34.1-NE) | 65% | Infusion-related reactions, neutropenia |
| Rd | 76.4% (P < .0001) | 49.3%, P < .0001 | 17.5 (13.9-20.8), P < .0001 | 57% | ||||
| ASPIRE10,11 | Phase 3 randomized | KRd | 2 (1-3) | 87.1% | 69.9% | 26.1 (23.3-30.5) | 48.3 (42.4-52.8) | Diarrhea, cough, URTI, fever, hypokalemia, hypertension, cardiac failure, renal failure, ischemic heart disease |
| Rd | 66.7%, P < .001 | 40.4%, P < .001 | 16.6 (15-20.6), P < .001 | 40.4 (33.6-44.4) P = .0045 | ||||
| TOURMALINE-MM112,13 | Phase 3 randomized | Ixa-Rd | (1-3) | 78.3% | 48% | 20.6 | 53.6 (49.2-62.9) | Rash, GI side effects, thrombocytopenia, peripheral neuropathy |
| Rd | 71.5%, P = .04 | 39% P = .01 | 14.7 P = .01 | 51.6, (44.7-59.1) P = .495 | ||||
| ELOQUENT-214,15 | Phase 3 randomized | Elo-Rd | 2 (1-4) | 79% | 33% | 19.4 | 43.7 | Grade 3/4 lymphopenia, GI side effects, fatigue, cough, fever, nasopharyngitis |
| Rd | 66%, P < .001 | 28% | 14.9 P = .0014 | 39.6, P = .025 | ||||
| APOLLO18 | Phase 3 randomized | Dara-Pd | 2 (1-5) | 69% | 51% | 12.4 (8.3-19.3) | NA | Grade 3/4 neutropenia, pneumonia, lower respiratory tract infection |
| Pd | 46%, P < .0001 | 20%, P < .0001 | 6.9 (5.5-9.3) P = .001 | |||||
| OPTIMISSM19 | Phase 3 randomized | PVd | 2 (1-2) | 82.2% | 52.7% | 11.2 (9.66–13.73) | NA | Neutropenia, febrile neutropenia, thrombocytopenia |
| Vd | 50%; P < .0001 | 18.3%; P < .0001 | 7.1 (5.88–8.48); P < .0001 | |||||
| EMN011/HO11432 | Phase 2 | KPd | 1 | 87% | 65% | 18 P = .14 | Febrile neutropenia, infection, cardiovascular, neuropathy, cytopenias | |
| Name of the study . | Regimen trial . | Patient group . | Median prior lines of therapy (range) . | Response ORR ≥ VGPR . | Median PFS (months) . | Median OS (months) . | Toxicity . | |
|---|---|---|---|---|---|---|---|---|
| POLLUX8,9 | Phase 3 randomized | Dara-Rd | 1 (1-11) | 92.9% | 80.4% | 44.5 (34.1-NE) | 65% | Infusion-related reactions, neutropenia |
| Rd | 76.4% (P < .0001) | 49.3%, P < .0001 | 17.5 (13.9-20.8), P < .0001 | 57% | ||||
| ASPIRE10,11 | Phase 3 randomized | KRd | 2 (1-3) | 87.1% | 69.9% | 26.1 (23.3-30.5) | 48.3 (42.4-52.8) | Diarrhea, cough, URTI, fever, hypokalemia, hypertension, cardiac failure, renal failure, ischemic heart disease |
| Rd | 66.7%, P < .001 | 40.4%, P < .001 | 16.6 (15-20.6), P < .001 | 40.4 (33.6-44.4) P = .0045 | ||||
| TOURMALINE-MM112,13 | Phase 3 randomized | Ixa-Rd | (1-3) | 78.3% | 48% | 20.6 | 53.6 (49.2-62.9) | Rash, GI side effects, thrombocytopenia, peripheral neuropathy |
| Rd | 71.5%, P = .04 | 39% P = .01 | 14.7 P = .01 | 51.6, (44.7-59.1) P = .495 | ||||
| ELOQUENT-214,15 | Phase 3 randomized | Elo-Rd | 2 (1-4) | 79% | 33% | 19.4 | 43.7 | Grade 3/4 lymphopenia, GI side effects, fatigue, cough, fever, nasopharyngitis |
| Rd | 66%, P < .001 | 28% | 14.9 P = .0014 | 39.6, P = .025 | ||||
| APOLLO18 | Phase 3 randomized | Dara-Pd | 2 (1-5) | 69% | 51% | 12.4 (8.3-19.3) | NA | Grade 3/4 neutropenia, pneumonia, lower respiratory tract infection |
| Pd | 46%, P < .0001 | 20%, P < .0001 | 6.9 (5.5-9.3) P = .001 | |||||
| OPTIMISSM19 | Phase 3 randomized | PVd | 2 (1-2) | 82.2% | 52.7% | 11.2 (9.66–13.73) | NA | Neutropenia, febrile neutropenia, thrombocytopenia |
| Vd | 50%; P < .0001 | 18.3%; P < .0001 | 7.1 (5.88–8.48); P < .0001 | |||||
| EMN011/HO11432 | Phase 2 | KPd | 1 | 87% | 65% | 18 P = .14 | Febrile neutropenia, infection, cardiovascular, neuropathy, cytopenias | |
Dara, daratumumab; GI, gastrointestinal; Ixa, ixazomib; KPd, carfilzomib-pomalidomide/dexa; KRd, carfilzomib-lenalidomide-dexamethasone; NA, not available; NE, not evaluable; Pd, pomalidomide-dexamethasone; PVd, pomalidomide-bortezomib-dexamethasone; Rd, lenalidomide-dexamethasone; URTI, upper respiratory tract infection; Vd, bortezomib-dexamethasone.