Table. Randomized comparative studies on the therapy of multiple myeloma (in alphabetical order)*1.
| Median PFS | Median OS | SAE | Response | CR | |||||||||||
| Study | Study register | Inter- vention | Comparison | Inter- vention | Comparison | HR for PFS[95% CI] | Inter- vention | Comparison | HR for OS[95% CI] | Inter- vention | Comparison | Inter- vention | Comparison | Inter- vention | Comparison |
| First line, transplant-ineligible | |||||||||||||||
| ALCYONE (e1, e2) | NCT02195479 | Dara VMP | VMP | 36 | 19 | 0.42 [0.34; 0.51] | NR | NR | 0.60 [0.46; 0.80] | 42% | 33% | 91% | 74% | 43% | 24% |
| MAIA (e3, e4) | NCT02252172 | Dara Rd | Rd | NR | 32 | 0.56 [0.43; 0.73] | NR | NR | 0.68 [0.53; 0.86] | 63% | 63% | 80% | 66% | 48% | 25% |
| SWOG S0777 (e5) | NCT00644228 | VRd | Rd | 43 | 30 | 0.71 [0.56; 0.91] | 75 | 64 | 0.71 [0.52; 0.96] | 52 % | 47% | 82% | 72% | 16% | 8% |
| Relapse | |||||||||||||||
| APOLLO (e6) | NCT03180736 | Dara Pd | Pd | 12 | 7 | 0.63 [0.47; 0.85] | NR | NR | − | 50 % | 39% | 69% | 46% | 25% | 4% |
| ASPIRE (e7) | NCT01080391 | KRd | Kd | 26 | 17 | 0.66 [0.55; 0.78] | 48 | 40 | 0.79 [0.67; 0.95] | 65% | 57% | 87% | 67% | 32% | 9% |
| BOSTON (e8) | NCT03110562 | SVd*2 | Vd | 14 | 10 | 0.70 [0.53; 0.93] | NR | 25 | 0.84 [0.57; 1.23] | 24% | 30% | 76% | 62% | 17% | 10% |
| CANDOR (e9) | NCT03158688 | Dara Kd | Kd | 29 | 15 | 0.59 [0.45; 0.78] | NR | NR | − | 56% | 46% | 84% | 73% | 33% | 13% |
| CASTOR (e10) | NCT02136134 | Dara Vd | Vd | 17 | 7 | 0.31 [0.24; 0.39] | NR | NR | − | 42% | 34% | 84% | 63% | 19% | 9% |
| ELOQUENT-2 (e11) | NCT01239797 | Elo Rd | Rd | 19 | 15 | 0.71 [0.59; 0.86] | 48 | 40 | 0.78 [0.63; 0.96] | 65% | 56% | 79% | 66% | 4% | 7% |
| ELOQUENT-3 (e12) | NCT02654132 | Elo Pd | Pd | 10 | 5 | 0.54 [0.34; 0.86] | NR | NR | − | 53% | 55% | 53% | 26% | 8% | 2% |
| ENDEAVOR (e13, e14) | NCT01568866 | Kd | Vd | 19 | 9 | 0.53 [0.44; 0.65] | 48 | 39 | 0.76 [0.63; 0.92] | 59% | 40% | 77% | 63% | 13% | 6% |
| ICARIA-MM (e15) | NCT02990338 | Isa Pd | Pd | 12 | 7 | 0.60 [0.44; 0.81] | NR | NR | 0.69 [0.46; 1.0] | 62% | 54% | 60% | 35% | 5% | 1% |
| IKEMA (e16) | NCT03275285 | Isa Kd | Kd | NR | 19 | 0.53 [0.32; 0.89] | NR | NR | − | 59% | 57% | 87% | 83% | 40% | 28% |
| OPTIMISMM (e17) | NCT01734928 | PVd | Vd | 11 | 7 | 0.61 [0.49; 0.77] | NR | NR | 0.98 [0.73; 1.32] | 61% | 43% | 82% | 50% | 16% | 4% |
| POLLUX (e18) | NCT02076009 | Dara Rd | Rd | 45 | 18 | 0.44 [0.35; 0.55] | NR | NR | − | 49% | 42% | 93% | 76% | 57% | 23% |
| TOURMALINE-1 (e19, e20) | NCT01564537 | Ixa Rd | Rd | 21 | 15 | 0.74 [0.59; 0.94] | 54 | 52 | 0.94 [0.78; 1.13] | 40% | 44% | 78% | 72% | 14% | 7% |
*1 This table is not part of the guideline but presents the underlying clinical results.
*2 Selinexor is currently approved only in combination with dexamethasone, but not in combination with bortezomib and dexamethasone.
Approved treatment for recurrence without results from randomized comparative studies: belantamab mafodotin, idecabtagene vicleucel
Dara, daratumumab; d, dexamethasone; Elo, elotuzumab; Isa, isatuximab; Ixa, ixazomib; K, carfilzomib; M, melphalan; P, pomalidomide; R, lenalidomide; S, selinexor; V, bortezomib;
CR, complete response; HR, Hazard Ratio; NR, not reached; OS, overall survival in months; PFS, progression-free survival in months;
SAE, severe adverse events; 95% CI, 95% confidence interval