OncoMatch/Clinical Trials/NCT06822972
HCMT/MM2401: Ph2 Study of Selinexor + Bispecific Antibody for RRMM
Is NCT06822972 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Selinexor 40 mg for multiple myeloma in relapse.
Treatment: Selinexor 40 mg — The primary objectives of this study are to determine the safety of single agent Selinexor given with commercial bispecific antibody therapy in patients with Relapsed/Refractory Multiple Myeloma (RRMM) and to determine the MRD negativity rate at 10-5 at 12 months post bispecific antibody therapy. The investigators will enroll 27 patients with RRMM who are receiving commercial bispecific antibody therapy. Patients will be on treatment for 12 months or until disease progression, and will be followed for 24 months. Study assessments include completing a drug diary, having a safety check in call, and have history, clinical assessments, and labs taken. Twenty-seven patients will provide 80% power in a one-sample chi square test for a proportion assuming that the rate of negative MRD at 10-5 at 12 months post bispecific antibody therapy is 25% in historical control and 50% in the SEL+bispecific antibody experimental treatment group, under a one-sided 5% significance level.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Prior lines of therapy must include a proteasome inhibitor
Must have received: immunomodulatory agent
Prior lines of therapy must include an immunomodulatory agent
Must have received: CD38 monoclonal antibody
Prior lines of therapy must include a CD38 monoclonal antibody
Cannot have received: SINE compound (selinexor)
Exception: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.
Patients who have received and were refractory to selinexor or another specific inhibitor of nuclear exporter (SINE) compound previously. Note: Patients who were exposed to selinexor or another SINE compound but were not refractory are eligible.
Lab requirements
Blood counts
ANC ≥1500/mm3; Hemoglobin ≥8.5 g/dL; Platelet count ≥100,000/mm3 (<50% plasma cells) or ≥50,000/mm3 (≥50% plasma cells); patients may receive growth factor support and transfusions as per protocol
Kidney function
Creatinine clearance ≥ 15 mL/min (Cockcroft-Gault formula)
Liver function
Total bilirubin <1.5 × ULN (except Gilbert's syndrome <3 × ULN); AST and ALT normal to <2.5 × ULN
Cardiac function
No symptomatic ischemia, uncontrolled clinically significant conduction abnormalities (except first degree AV block or asymptomatic LAFB/RBBB), no NYHA Class ≥3 CHF, LVEF <40%, or MI within 3 months prior to C1D1
Adequate hepatic function...Total bilirubin <1.5 × ULN (except patients with Gilbert's syndrome who must have a total bilirubin of <3 × ULN), and AST and ALT normal to <2.5 × ULN. Adequate renal function...creatinine clearance ≥ 15 mL/min...Adequate hematopoietic function...ANC ≥1500/mm3; Hemoglobin ≥8.5 g/dL; Platelet count ≥100,000/mm3 (<50% plasma cells) or ≥50,000/mm3 (≥50% plasma cells)...Patients receiving hematopoietic growth factor support...are eligible. Patients must have at least a 1-week interval from the last platelet transfusion prior to the Screening platelet assessment. However, patients may receive RBC and/or platelet transfusions as clinically indicated per institutional guidelines during the study. Patients with active, unstable cardiovascular function, as indicated by the presence of any of the following: Symptomatic ischemia, Uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmics); note: patients with first degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block are eligible, Congestive heart failure of New York Heart Association Class ≥3, Known left ventricular ejection fraction <40%, Myocardial infarction within 3 months prior to C1D1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Duke University Health System · Durham, North Carolina
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