OncoMatch/Clinical Trials/NCT06246162
Mitoxantrone Hydrochloride Liposome Combination Regimen in the Treatment of High-risk/Extramedullary Multiple Myeloma
Is NCT06246162 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Lipo-MIT combination regimen for multiple myeloma.
Treatment: Lipo-MIT combination regimen — To evaluate the efficacy and safety of mitoxantrone Hydrochloride Hydrochloride Liposome combination regimen in the treatment of high-risk/extramedullary multiple myeloma
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Allowed: TP53 deletion (del17p)
high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test)
Allowed: IGH translocation t(4;14)
high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test)
Allowed: IGH translocation t(14;16)
high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test)
Allowed: CKS1B 1q21 amplification
high-risk multiple myeloma (del17p, t (4; 14), t (14; 16), 1q21 by FISH test)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic chemotherapy
Received systemic chemotherapy within 28 days before the first dose
Cannot have received: immunomodulatory agent (pomalidomide)
Exception: relapsed patients are resistant to pomalidomide in previous treatment or cannot accept pomalidomide treatment
Relapsed patients are resistant to pomalidomide in previous treatment or cannot accept pomalidomide treatment
Lab requirements
Blood counts
neutrophil count ≥1.0×10^9/L; for patients with plasma cells in bone marrow >50%, 0.5×10^9/L≤neutrophil count <1.0×10^9/L is allowed. For patients with platelets ≥100×10^9/L; plasma cells in bone marrow >50%, 50×10^9/L≤platelets <100×10^9/L; hemoglobin >8g/dL
Kidney function
creatinine ≤ 2.5 mg/dL
Liver function
AST and ALT ≤ 2.5 times the upper limit of normal value (for the same age group), or ≤ 5 times the upper limit of normal value in the presence of liver metastasis; total bilirubin ≤ 1.5 times the upper limit of normal value
Cardiac function
QTc interval >480ms or suffering from long QTc syndrome during screening; cardiac ejection fraction is lower than 50% or lower than the lower limit of the examination value range of the research center during screening
Blood routine: neutrophil count ≥1.0×10^9/L; for patients with plasma cells in bone marrow >50%, 0.5×10^9/L≤neutrophil count <1.0×10^9/L is allowed. For patients with platelets ≥100×10^9/L; plasma cells in bone marrow >50%, 50×10^9/L≤platelets <100×10^9/L; hemoglobin >8g/dL; Liver function: AST and ALT ≤ 2.5 times the upper limit of normal value (for the same age group), or ≤ 5 times the upper limit of normal value in the presence of liver metastasis; total bilirubin ≤ 1.5 times the upper limit of normal value; creatinine ≤ 2.5 mg/dL ; cardiac ejection fraction is lower than 50% or lower than the lower limit of the examination value range of the research center during screening
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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