Page 157 - Read Online

Page 76 Sadaf et al. J Transl Genet Genom 2022;6:63-83 https://dx.doi.org/10.20517/jtgg.2021.36

Table 5. Selinexor combination trials
Trial title Phase Drug combination Dose Results
STORM Trial II Selinexor + Dexamethasone Selinexor - 80 mg oral day 1 & 3 of Partial response 26%
NCT02336815 each week Clinical benefit rate (CBR) 39%
Dexa - 20 mg prior to each dose Median response duration 4.4 months
Median PFS 3.7 months
Median OS 8.6 months
Pt with molecular response had medial OS
of 15.6 months
BOSTON Trial III Selinexor + Dexamethasone + Selinexor - 100 mg once weekly PFS 13.93 months in SVd arm vs. 9.46
NCT03110562 Bortezomib (SVd) Dexa - 40 mg weekly months in Vd arm
Bortezomib - 1.3 mg/m 2

Further, 10 combination therapies of Selinexor in 11 treatment arms are under investigation in the STOMP Trial (NCT02343042).

Table 6. BCMA and non-BCMA CAR - T cell clinical trials in MM
No. of
Clinical trial Phase Dose Outcome
Pt.
6
Anti-BCMA CAR-T cell I 12 0.3, 1.0, 3.0, 9.0 × 10 CAR PR 3, SD 8, sCR 1
(NCT02215967) cells/kg
6
bb2121 Anti-BCMA CAR-T cell I 33 50, 150, 450, or 800 × 10 ORR 85%, sCR 12, CR 3, VGPR 9, PR 4,
(NCT02658929) CART cells SD 4, PD 1
6
bb21217 Anti-BCMA CAR-T cell I 8 150 × 10 CAR T cells sCR 1, VGPR 3, PR 2, -ve MRD 3
(NCT03274219)
6
LCAR-B38M Anti-BCMA CAR-T cell I 17 0.21-1.52 × 10 CAR T cells/kg ORR 88.2%, sCR 13, VGPR 2, NR 1
(ChiCTR-ONH-17012285)
6
LCAR-B38M Anti-BCMA CAR-T cell I/II 57 0.07-2.1 × 10 CAR T cells/kg ORR: 88%, CR 39; VGPR 3, PR 8, -ve
(NCT03090659) MRD 36
LEGEND-2 Trial
6
JCARH125 Anti-BCMA CAR-T cell I/II 19 50-150 × 10 CAR T cells/kg sCR 2, CR 1, VGPR 2, PR 2, MR1
(NCT03430011)
EVOLVE Trial
8
CT053 Anti-BCMA CAR-T cell - 16 0.5-1.8 × 10 CAR T cells ORR 100%, CR 2, PR 4, VGPR 6
(NCT03915184)
6
MCARH171 Anti-BCMA CAR-T cell I 11 72, 137, 475, 818 × 10 CAR T ORR 64%, VGPR 2
(NCT03070327) cells
6
CT103A Anti-BCMA CAR-T I 9 1, 3, 6 × 10 CAR T cells/kg ORR 100%, CR 4; VGPR1, PR 4
(ChiCTR1800018137)
7
CD3ζ & 4-1BB Anti-BCMA CAR-T cell I 25 1-50 × 10 CAR T cells sCR 1, CR 1, VGPR 5, PR 5
(NCT02546167)
6
P-BCMA-101 CAR-T cell I 12 48-430 × 10 CAR+ T cells sCR 1, nCR 1, VGPR 1, PR 2
(NCT03288493)
7
CD4+: CD8+ BCMA CAR-T cell I 7 5-15 × 10 CAR T cells ORR 100%
(NCT03338972)
8
Anti-CD19 non-BCMA CAR-T cell I 10 1.1-6.0 × 10 CAR T cells VGPR 6, PR 2; PD 2
(NCT02135406)
7
Anti-CD138 non-BCMA CAR-T cell I/II 5 0.44-1.51 × 10 CAR+ T cells/kg SD 4, PD 1
(NCT01886976)
8
κ light chain non-BCMA CAR-T cell I 16 0.2-2.0 × 10 CAR+ T cells/m 2 4 SD of 7 MM
(NCT00881920) (7MM)
ORR: Overall response rate; VGPR: very good partial response; CR: complete response; PR: partial response; sCR: stringent complete response;
MRD: minimal residual disease.
Targeted therapy for multiple myeloma
Clonal heterogeneity and clonal competition in the MM cancer cells have signified the role of targeted
therapy (precision medicine) in patient management. Therefore, the identification of driver mutations is
central to designing personalized targeted therapy. In addition, novel vaccines and immune-checkpoint