OncoMatch/Clinical Trials/NCT05530421
Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma
Is NCT05530421 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Selinexor and Venetoclax for relapsed and refractory multiple myeloma.
Treatment: Selinexor · Venetoclax · Dexamethasone — The purpose of this research is to determine whether the combination of selinexor, venetoclax, and dexamethasone therapy can increase anti-cancer effects in patients with translocation 11;14-positive (t(11;14)), relapsed/refractory myeloma (RRMM).
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: CCND1 t(11;14) translocation
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: immunomodulatory agent
refractory to, not a candidate for (ineligible), or intolerant of at least one immunomodulatory (IMiD)...based treatment
Must have received: proteasome inhibitor
refractory to, not a candidate for (ineligible), or intolerant of at least one...proteasome inhibitor...based treatment
Must have received: anti-CD38 monoclonal antibody
refractory to, not a candidate for (ineligible), or intolerant of at least one...anti-cluster of differentiation 38 (anti-CD38) monoclonal antibody-based treatment
Cannot have received: SINE compound (selinexor)
Has received selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously
Lab requirements
Blood counts
ANC ≥ 1000/mcL (G-CSF allowed); Platelets ≥ 50,000/mcL (transfusions and stimulators permitted); in patients with >50% bone marrow plasma cells, platelets ≥ 30,000/mcL; Hemoglobin ≥ 8 g/dL (transfusions permitted)
Kidney function
Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or calculated creatinine clearance (CrCl)/eGFR ≥ 15 mL/min/1.73 m2
Liver function
Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 X ULN); SGOT and SGPT ≤ 2.5 X ULN
Adequate organ function as evidenced by the following laboratory parameters within 4 weeks of C1D1: Hematologic: ANC ≥ 1000/mcL (G-CSF allowed); Platelets ≥ 50,000/mcL (transfusions and stimulators permitted); in patients with >50% bone marrow plasma cells, platelets ≥ 30,000/mcL; Hemoglobin ≥ 8 g/dL (transfusions permitted). Non-hematologic: Serum creatinine ≤ 1.5 X ULN (except if due to myeloma) or calculated creatinine clearance (CrCl)/eGFR ≥ 15 mL/min/1.73 m2; Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for patients with total bilirubin levels > 1.5 ULN (except patients with Gilbert's syndrome who must have a total bilirubin of < 3 X ULN); SGOT and SGPT ≤ 2.5 X ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami, Lennar Foundation Medical Center · Coral Gables, Florida
- University of Miami, Sylvester Comprehensive Cancer Center at Deerfield Beach · Deerfield Beach, Florida
- University of Miami, Sylvester Comprehensive Cancer Center · Miami, Florida
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