Key Trials | Patient Characteristics | Treatment | Comparator | Harms (Treatment Arm) |
---|---|---|---|---|
ASPIRE Open-label RCT Phase 3 Carfilzomib (CFZ) |
• Median age: 64 • ECOG = 2: 9.5% • ISS Stage III: 20% • Previous SCT: 57% • High risk: 12.6% • Prior regimens (median): 2 • Prior BOR: 65.8% • Prior LEN: 19.8% |
CFZ+LEN+DEX (n = 396) |
LEN+DEX (n = 396) |
• Discontinued d/t AEs: 15% • SAEs: 60% • Tx-related deaths: 2% |
• Median f/u: 32.3 m | • Median f/u: 31.5 m | |||
• OS HR: 0.79 (95% CI: 0.63-0.99; P = 0.04) • PFS HR: 0.69 (95% CI: 0.57-0.83) | ||||
• Median PFS: 26.3 m • ORR: 87.1% |
• Median PFS: 17.6 m • ORR: 66.7%, P < 0.001 |
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CASTOR Open-label RCT Phase 3 Daratumumab (DAR) |
• Median age: 64 • ECOG = 2: NR • ISS Stage III: 22% • Previous SCT: 61% • del(17p): 10% • Prior regimens (median): 2 • Prior BOR: 66% • Prior LEN: 76% |
DAR+BOR+DEX (n = 251) |
BOR+DEX (n = 247) |
• Discontinued d/t AEs: 7% • SAEs: 76% • Tx-related deaths: 5% |
• Median f/u: 7.4 m | ||||
• Deaths: 11.6% | • Deaths: 14.6% | |||
• PFS HR: 0.39 (95% CI: 0.28-0.53; P < 0.001) | ||||
• Median PFS: NR • ORR: 82.9% |
• Median PFS: 7.2 m • ORR: 63.2% |
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POLLUX Open-label RCT Phase 3 Daratumumab (DAR) |
• Median age: 65 • ECOG = 2: 5% • ISS Stage III: 20% • Previous SCT: 63% • del(17p): 8% • Prior regimens (median): 1 • Prior BOR+LEN: 15% |
DAR+LEN+DEX (n = 286) |
LEN+DEX (n = 283) |
• Discontinued d/t AEs: 8% • SAEs: 49% • Tx-related deaths: 4% |
• Median f/u: 13.5 m | ||||
• Deaths: 10.5% | • Deaths: 15.9% | |||
• PFS HR: 0.37 (95% CI: 0.27-0.52; P < 0.001) | ||||
• Median PFS: NR • ORR: 92.9% |
• Median PFS: 18.4 m • ORR: 76.4% |
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ELOQUENT-2 Open-label RCT Phase 3 Elotuzumab (ELO) |
• Median age: 66 • ECOG = 2: 9% • ISS Stage III: 21% • Previous SCT: 54% • del(17p): 32% • Prior regimens (median): 2 • Prior BOR: 70% • Prior LEN: 6% |
ELO+LEN+DEX (n = 321) |
LEN+DEX (n = 325) |
• Discontinued d/t AEs: 13% • SAEs: 65% • Tx-related deaths: 2% |
• Median f/u: 24.5 m • OS HR: 0.71 (95% CI: 0.54-0.93) • PFS HR: 0.70 (95% CI: 0.57-0.85; P < 0.001) | ||||
• Median PFS: 19.4 m • ORR: 79% |
• Median PFS: 14.9 m • ORR: 66%, P < 0.001 |
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TOURMALINE-MM1 Double-blind RCT Phase 3 (unpublished) Ixazomib (IX) |
• Median age: 66 • ECOG = 2: 6% • ISS Stage III: 13% • Previous SCT: 57% • High risk: 19% • Prior regimens (median): 2 • Prior BOR: 69% • Prior LEN: 12% |
IX+LEN+DEX (n = 360) |
Placebo+LEN+DEX (n = 362) |
• Discontinued d/t AEs: 13% • SAEs: 40% • Tx-related deaths: NR |
• Median f/u (PFS): 23 m | ||||
• Deaths: 22.5% | • Deaths: 24.8% | |||
• PFS HR: 0.74 (95% CI: 0.59-0.94; P = 0.012) | ||||
• Median PFS: 20.6 m • ORR: 78% |
• Median PFS: 14.7 m • ORR: 72%, P < 0.001 |
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PANORAMA-1 Double-blind RCT Phase 3 Panobinostat (PAN) |
• Median age: 63 • ECOG = 2: 5% • ISS Stage III: 22% • Previous SCT: 58% • 1 prior regimen: 51% • Prior BOR+DEX: 38% • Prior LEN: 21% |
PAN+BOR+DEX (n = 387) |
Placebo+BOR+DEX (n = 381) |
• Discontinued d/t AEs: 36% • SAEs: 60% • Tx-related deaths: 3% |
• Median f/u: 6.4 m | • Median f/u: 5.9 m | |||
• OS HR: 0.87 (95% CI: 0.69-1.10; P = 0.26) • PFS HR: 0.63 (95% CI: 0.52-0.76; P < 0.0001) | ||||
• Median PFS: 11.99 m • ORR: 60.7% |
• Median PFS: 8.08 m • ORR: 54.6%, P = 0.09 |
AE = adverse event; BOR = bortezomib; CI = confidence interval; del(17p) = deletion in 17 p region of tumor protein 53 gene; DEX = dexamethasone; d/t = due to; ECOG=Eastern Cooperative Oncology Group; f/u = follow-up; HR = hazard ratio; ISS = International Staging System; LEN = lenalidomide; NR = not reported; ORR = objective response rate; OS = survival; PFS = progression-free survival; RCT = randomized controlled trial; SAE = serious adverse event; SCT = stem cell transplant; Tx = treatment.