Table 3.
Major clinical trials and real-world studies based on carfilzomib for the treatment of RRMM.
| Study | Age* | Median lines (range)/prior exposure | ResponseORR/≥VGPR/≥CR | PFS/OS/DOT/TTNT | Toxicity, G≥3 |
|---|---|---|---|---|---|
| MAJOR CLINICAL TRIALS | |||||
|
ASPIRE (9, 55) KRd: N=396 |
64 | 2 (1-3)/ Bort-exposed: 65% Len-exposed: 20% |
- 87%/70%/31% | mPFS: 26 mo mOS: 48.3 mo mDOT: 72 weeks (~16.5 mo) |
- Neutropenia 30% - Thrombocytopenia 20% - Pneumonia 16% - Hypertension 6% - Heart failure 4% - Ischemic heart disease 4% |
|
ENDEAVOR (53, 54) Kd: N=464 |
65 | 2 (1-2)/ Bort-exposed: 54% Len-exposed: 38% |
- 77%/54%/13% | mPFS: 18 mo mOS: 47 mo mDOT: 40 weeks (~9.2 mo) |
- Neutropenia 3% - Thrombocytopenia 12% - Pneumonia 7% - Hypertension 15% - Heart failure 6% - Ischemic heart disease 3% |
| MAJOR REAL-WORLD STUDIES | |||||
|
20150262 (NCT03091127), Terpos et al., 2020 (56) KRd: N=382 Kd: N=273 |
KRd: 65 Kd: 68 |
KRd: 1 (NA) Kd: 3 (NA)/ Bort-exposed: 97% Len-exposed: KRd 34%, Kd 68% ASCT: KRd 63%, Kd 44% |
KRd: - 83%/66%/31% Kd: - 68%/42%/13% |
mPFS: NA mOS: NA mDOT: - KRd 14.6 mo - Kd 7.5 mo |
KRd: - Hematologic AEs 20% - Infection 14% - Vascular AEs 7% Kd: - Hematologic AEs 14% - Infection 16% - Vascular AEs 5% |
|
Rete Ematologica Pugliese, Mele et al., 2021 (57) KRd: N=130 |
66 | 1 (NA)/ Bort-exposed: 97% Len-exposed: 36% |
- 79%/54%/37% | mPFS: 24 mo mOS: NA |
- Hematologic AEs 9% - Infection 2% (any G 14%) - Cardiac AEs 3% (any G 11%) - SPM 3% |
|
Rocchi et al., 2021 (58) KRd: N=197 |
63 | 2 (NA)/ Bort-exposed: 96% Len-exposed: 45% (ref: 22%) |
- 88%/50%/21% | mPFS: 19.8 mo 1-y OS rate: 80% mDOT: NA |
- Neutropenia 21% - Infection 11% - Hypertension 6% - Heart failure 1% |
|
Davies et al., 2021 (52) KRd: N=218 |
64 | NA (53% ≥3 lines)/ PI+IMiD-exposed: 67% (ref: 21%) |
– | mDOT: 7 mo mTTNT: 8.7 mo |
NA |
*Age: median age.
RRMM, relapsed/refractory multiple myeloma; K, carfilzomib; R, Len, lenalidomide; d, dexamethasone; N, number; Bort, bortezomib; NA, not available; ref, refractory; PI, proteasome inhibitor; IMiD, immunomodulatory drug; ORR, overall response rate; ≥VGPR, at least a very good partial response; ≥CR, at least a complete response; PFS, progression-free survival; OS, overall survival; DOT, duration of treatment; TTNT, time to next treatment; mPFS, median PFS; mOS, median OS; mDOT, median DOT; mTTNT, median TTNT; mo, months; y, years; G, grade; AEs, adverse events; SPM, second primary malignancy.