Table 5.
Active* clinical trials including selinexor (where recruitment is ongoing or anticipated)
| Trial | Phase | N | Inclusion | Intervention | Primary endpoint | Status |
|---|---|---|---|---|---|---|
| NDMM | ||||||
| NCT04717700 | 2 | 100 | Transplant ineligible |
Selinexor + V/R (alternating) + dexversus VRD light |
ORR | Recruiting |
| NCT04782687 | 2 | 100 | Transplant ineligible | Selinexor + DRd | CR, sCR, safety | Recruiting |
| NDMM + RRMM | ||||||
|
(STOMP) |
1b/2 | 518 | Specific to treatment arm | Selinexor + dexamethasone with: P, V, R, PV, Daratumumab, K, R, ixazomib, P + elotuzumab, belamaf, P + daratumumab | Safety, duration of response, ≥ MR | Recruiting |
| RRMM | ||||||
| NCT04891744 | 1/2 | 48 | ≥ 1 prior line | Selinexor + Td | ORR | NYR (start: July 2021) |
| NCT04925193 | 2 | 20 | ≥ 1 prior line |
Selinexor + Pd,or Selinexor + Kd,or Selinexor + daratumumab + dex |
ORR | Recruiting |
| NCT05170789 | 2 | 18 | ≥ 1 prior line | Selinexor + elotuzumab + dexamethasone | ORR | NYR (start: January 2022) |
| NCT04877275 | 2 | 50 | ≥ 1 prior line |
Selinexor + doxorubicin + dex,or Selinexor + cyclophosphamide + dex |
ORR | Recruiting |
| NCT04941937 | 2 | 90 | ≥ 1 prior line |
Selinexor + Td or Selinexor + Rd or Selinexor + Pd |
ORR | Recruiting |
|
(MyDRUG) |
1/2 | 228 | 1–3 prior lines with early relapse |
Selinexor + ixazomib + Pd versus7 other treatment arms |
ORR | Recruiting |
| NCT02199665 | 1 | 100 | ≥ 2 prior lines | Selinexor + Kd | MTD | Recruiting |
|
(MARCH) |
2 | 82 | IMID and PI refractory | Selinexor + dexamethasone | ORR | Recruiting |
| NCT04661137 | 2b | 96 | K or P refractory |
Selinexor + Pd,or Selinexor + Kd,or Selinexor + daratumumab + dex (exploratory) |
ORR | Recruiting |
| NCT04756401 | 2 | 52 | 1–3 prior lines, high riska | Selinexor + Kd + daratumumab | MRD(-) | NYR (start: August 2022) |
| NCT04843579 | 2 | 26 | 1–4 prior lines | Selinexor + Pd + clarithromycin | ORR | Recruiting |
| NCT04414475 | 2b | 134 | > 1–5 prior lines (based on treatment arm) |
Selinexor + dex (varying doses),versus Selinexor + Vd |
ORR | Recruiting |
| NCT05028348 | 3 | 280 | 1–4 prior lines |
Selinexor + Pdversus Elotuzumab + Pd |
PFS | NYR (start: March 2022) |
| NCT04939142 | 3 | 150 | 1–3 prior lines |
Selinexor + Vd,versus Vd |
PFS | Recruiting |
| NCT04519476 | Pilot | 22 | ≥ 3 prior lines | Selinexor + lenalidomide + methylprednisolone | ORR, CBR | Recruiting |
| NCT04764942 | 1/2 | 81 | ≥ 2–3 prior lines (based on treatment arm), PI/IMID refractory | Selinexor + Pd ± carfilzomib | MTD, ORR | Recruiting |
| NCT05201118 | 1 | 30 | ≥ 3 prior lines, extramedullary disease, | Selinexor + CT103A (anti-BCMA CART) | PFS, ORR, DOR | NYR (start: February 2022) |
| NCT03589222 | 2 | 62 | ≥ 3 prior lines | Selinexor + Vd + daratumumab | ORR | Recruiting |
Bold data: Disease status at trial inclusion
Abbreviations: NDMM, newly diagnosed multiple myeloma; RRMM, relapsed refractory multiple myeloma; ORR, overall response rate being ≥ partial response; CBR, clinical benefit rate; CR, complete response rate; sCR, stringent complete response; PFS, progression-free survival; DOR, duration of response; MTD, maximum tolerated dose; MR, minimal response; MRD, minimal residual disease; NYR, not yet recruiting; V, bortezomib; R, lenalidomide; DRD, daratumumab + lenalidomide + dexamethasone; BCMA, B-cell maturation antigen; CART, chimeric antigen receptor T-cell; Pd, pomalidomide + dexamethasone; Kd, carfilzomib + dexamethasone; Vd, bortezomib + dexamethasone; P, pomalidomide; Td, thalidomide + dexamethasone; Rd, lenalidomide + dexamethasone; IMID, immunomodulatory drug; PI, proteosome inhibitor
aHigh-risk MM defined as at least one of del1p, gain1q (≥ 3 copies), del17p, t(4;14), t(14;16), t(14;20), LDH above upper limit of normal, extramedullary disease, ISS stage 3 at relapse, ≥ 5% circulating plasma cells at relapse, high-risk gene expression profiling, relapse < 18 months on upfront transplant-ineligible regimen, and < 36 months post-ASCT on maintenance
*This table was up to date as of at the date of manuscript submission