OncoMatch/Clinical Trials/NCT05422027
Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma
Is NCT05422027 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Selinexor and Bortezomib for multiple myeloma.
Treatment: Selinexor · Bortezomib · Lenalidomide · Dexamethasone — This is a single-arm and open-label study to explore XVRd (ATG-010, Bortezomib, Lenalidomide and Dexamethasone) regimen in high-risk newly diagnosed multiple myeloma.The primary objective of the dose escalation study is to determine the safety, tolerability, and recommended phase II dose (RP2D) of selinexor; Then dose expansion at the RP2D level based on dose escalation phase will be conducted to evaluate the efficacy, safety and tolerability.The enrollment period for this study is expected to be approximately 12 months. The study will end when all patients have completed 12 cycles treatment/follow-up since the initiation of the study drug, or the last patient has expired, has been lost to follow-up, or has withdrawn consent, whichever occurs first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: IGH t(4;14)
High Risk genetic Abnormalities t(4;14)
Required: IGH t(14;16)
High Risk genetic Abnormalities t(14;16)
Required: IGH t(14;20)
High Risk genetic Abnormalities t(14;20)
Required: TP53 deletion
High Risk genetic Abnormalities Del 17p
Required: TP53 mutation
High Risk genetic Abnormalities p53 mutation
Required: CKS1B gain 1q
High Risk genetic Abnormalities Gain 1q
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Patients must have received no prior chemotherapy for multiple myeloma
Cannot have received: radiation therapy
Exception: no prior radiotherapy to a large area of the pelvis (more than half of the pelvis)
Patients must have received no prior radiotherapy to a large area of the pelvis (more than half of the pelvis)
Cannot have received: steroid
Exception: maximum of 14 days of treatment for symptom control
Patients must have received no prior steroid treatment for myeloma with the exception of a maximum of 14 days of treatment for symptom control
Cannot have received: SINE compound (ATG-010)
Prior exposure to a SINE compound, including ATG-010
Lab requirements
Blood counts
WBC ≥1.5×10^9/L, ANC ≥1.0×10^9/L, HB ≥85g/L, PLT ≥75×10^9/L (<50% plasma cells) or PLT ≥50×10^9/L (≥50% plasma cells)
Kidney function
estimated creatinine clearance ≥ 30 mL/min (Cockroft-Gault)
Liver function
total bilirubin < 1.5× ULN (Gilbert's syndrome: < 3× ULN), AST < 2× ULN, ALT < 2× ULN
Adequate hepatic function: total bilirubin < 1.5× ULN (for patients with Gilbert's syndrome, < 3× ULN), AST < 2× ULN, and ALT < 2× ULN. Adequate renal function: estimated creatinine clearance ≥ 30 mL/min (Cockroft-Gault). Adequate hematopoietic function: WBC ≥1.5×10^9/L, ANC ≥1.0×10^9/L, HB ≥85g/L, PLT ≥75×10^9/L (<50% plasma cells) or PLT ≥50×10^9/L (≥50% plasma cells).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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