Lenalidomide-based regimens
Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
---|---|---|---|---|---|---|---|---|---|---|---|
Richardson et al, 200925 | 2 | 222 | R | R 30 mg on days 1-21 q 28 d | 3 | 26 | 4.9 | 23.2 | NR | N 60%, T 39%, A 20% | |
Weber et al, 200715 | 3 | 177 | Rd | R 25 mg/d on days 1-21, D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 61 | 24.3 | 11.1 | 29.6 | 17.6 | N 41.2%, A 13%, T 14.7%, F 6.8%, I 34.9% |
176 | D | D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 19.9 | 1.7 | 4.7 | 20.2 | N 4.5%, A 5.1%, T 6.9%, F 6.3%, I 20.5% | |||
P | <.001 | <.0001 | <.0001 | ||||||||
Dimopoulos et al, 200716 | 3 | 176 | Rd | R 25 mg/d on days 1-21, D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 60.2 | 24.4 | 11.3 | NR | 16.4 (TTP) | N 29.5%, A 8.6%, T 11.4%, F 6.8%, I 11.3%, DVT 4% |
175 | D | D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 24 | 5.1 | 4.7 | 20.6 | N 2.3%, A 6.9%, T 5.7%, F 3.4%, I 6.2%, DVT 3.5% | |||
P | <.0001 | <.0001 | .03 | ||||||||
Richardson et al, 201221 | 2 | 36 | Rd+Elotuzumab | E 10 mg/kg IV qw × 2 cycles, q2w afterward; R 25 mg/d on days 1-21; D 40 mg/d on days 1, 8, 15, 22, orally every 28 d | ≥2 | 92 | 61 | 26.9 | NR | 18.1 | N 14%, A 11%, T 17%, F 8%, D 8% |
37 | Rd+Elotuzumab | E 20 mg/kg IV qw × 2 cycles, q2w afterward; R 25 mg/d on days 1-21; D 40 mg on days 1, 8, 15, 22, orally every 28 d | ≥2 | 76 | 46 | 18.6 | NR | N 19%, A 14%, T 16%, F 5%, D 5% | |||
Wang et al, 201324 | 2 | 52 | CRd | C 20/27 mg/m2 on days 1, 2, 8, 9, 15, 16; R 25 mg on days 1-21; D 40 mg on days 1, 8, 15, 22 q 28 d | NR | 78 | 22 | 15.4 | NR | 24.4 | L 48.1%, N 32.7%, T 19.2%, A 19.2%, DVT 7.7% |
Richardson et al, 201423 | 2 | 64 | RVD | R 15 mg/d (days 1-14), V 1 mg/m2 on days 1, 4, 8, 11; D 40/20 mg/d | 2 | 64 | 28 | 9.5 | 30 | 44 | N 30%, T 22%, L 11% |
Baz et al, 200620 | 2 | 52 | RD+PLD+Vincristine | R 10 mg/d on days 1-21, D 40 mg/d on days 1-4, orally every 28 d; PLD 40 mg/m2 IV and vincristine 2 mg IV on day 1; every 28 d | 75 | 29 | 61% | 84% | 7.6 | N 32%, FN 7%, TEE 9%, PN 5% | |
Reece et al, 201419 | 1/2 | 32 | CyPR | Cy 300 mg/m2 on days 1,8, 15; P 100 mg qod R 25 mg days1-21 every 28 d | 2 | 94 | 16.1 | 27.6 | 28 | FN 16%, TEE 9%, Di 9% |
Study . | Phase . | N . | Regimen . | Dose . | Prior lines . | ≥PR % . | ≥VGPR % . | PFS (m) . | OS (m) . | Median f/u (m) . | ≥G3 toxicities . |
---|---|---|---|---|---|---|---|---|---|---|---|
Richardson et al, 200925 | 2 | 222 | R | R 30 mg on days 1-21 q 28 d | 3 | 26 | 4.9 | 23.2 | NR | N 60%, T 39%, A 20% | |
Weber et al, 200715 | 3 | 177 | Rd | R 25 mg/d on days 1-21, D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 61 | 24.3 | 11.1 | 29.6 | 17.6 | N 41.2%, A 13%, T 14.7%, F 6.8%, I 34.9% |
176 | D | D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 19.9 | 1.7 | 4.7 | 20.2 | N 4.5%, A 5.1%, T 6.9%, F 6.3%, I 20.5% | |||
P | <.001 | <.0001 | <.0001 | ||||||||
Dimopoulos et al, 200716 | 3 | 176 | Rd | R 25 mg/d on days 1-21, D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 60.2 | 24.4 | 11.3 | NR | 16.4 (TTP) | N 29.5%, A 8.6%, T 11.4%, F 6.8%, I 11.3%, DVT 4% |
175 | D | D 40 mg/d on days 1-4, 9-12, 17-20, orally every 28 d | ≥2 | 24 | 5.1 | 4.7 | 20.6 | N 2.3%, A 6.9%, T 5.7%, F 3.4%, I 6.2%, DVT 3.5% | |||
P | <.0001 | <.0001 | .03 | ||||||||
Richardson et al, 201221 | 2 | 36 | Rd+Elotuzumab | E 10 mg/kg IV qw × 2 cycles, q2w afterward; R 25 mg/d on days 1-21; D 40 mg/d on days 1, 8, 15, 22, orally every 28 d | ≥2 | 92 | 61 | 26.9 | NR | 18.1 | N 14%, A 11%, T 17%, F 8%, D 8% |
37 | Rd+Elotuzumab | E 20 mg/kg IV qw × 2 cycles, q2w afterward; R 25 mg/d on days 1-21; D 40 mg on days 1, 8, 15, 22, orally every 28 d | ≥2 | 76 | 46 | 18.6 | NR | N 19%, A 14%, T 16%, F 5%, D 5% | |||
Wang et al, 201324 | 2 | 52 | CRd | C 20/27 mg/m2 on days 1, 2, 8, 9, 15, 16; R 25 mg on days 1-21; D 40 mg on days 1, 8, 15, 22 q 28 d | NR | 78 | 22 | 15.4 | NR | 24.4 | L 48.1%, N 32.7%, T 19.2%, A 19.2%, DVT 7.7% |
Richardson et al, 201423 | 2 | 64 | RVD | R 15 mg/d (days 1-14), V 1 mg/m2 on days 1, 4, 8, 11; D 40/20 mg/d | 2 | 64 | 28 | 9.5 | 30 | 44 | N 30%, T 22%, L 11% |
Baz et al, 200620 | 2 | 52 | RD+PLD+Vincristine | R 10 mg/d on days 1-21, D 40 mg/d on days 1-4, orally every 28 d; PLD 40 mg/m2 IV and vincristine 2 mg IV on day 1; every 28 d | 75 | 29 | 61% | 84% | 7.6 | N 32%, FN 7%, TEE 9%, PN 5% | |
Reece et al, 201419 | 1/2 | 32 | CyPR | Cy 300 mg/m2 on days 1,8, 15; P 100 mg qod R 25 mg days1-21 every 28 d | 2 | 94 | 16.1 | 27.6 | 28 | FN 16%, TEE 9%, Di 9% |
A, anemia; CRd, carfilzomib, lenalidomide, and dexamethasone; Cy, cyclophosphamide; Di, diarrhea; DVT, deep venous thrombosis; E, elotuzumab; F, fevers; FN, febrile neutropenia; f/u, follow-up; G, grade; I, infections; IV, intravenous; L, lymphopenia; m, months; N, neutropenia; NR, not reported; OS, overall survival; P, prednisone; PFS, progression-free survival; PLD, pegylated liposomal doxorubicin; PO, per os; PR, partial response; qod, every other day; R, lenalidomide; Rd, lenalidomide and low-dose dexamethasone; RD, lenalidomide and high-dose dexamethasone; SC, subcutaneous; T, thrombocytopenia; TEE, thromboembolic events; TTP, time to progression; VGPR, very good partial response; yr, years.