OncoMatch/Clinical Trials/NCT05530421
Selinexor, Venetoclax, and Dexamethasone (XVenD) in t(11;14)-Positive Relapsed/Refractory Multiple Myeloma
Is NCT05530421 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05530421 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior SINE compound disqualifies patients from enrollment.
Does this trial require CCND1?
Yes, CCND1 t(11;14) translocation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages