This study aims to evaluate the safety and efficacy of Linperlisib combined with the VRD regimen in the treatment of newly diagnosed patients with multiple myeloma. The study is divided into a Phase Ib dose exploration phase and a Phase II expansion phase.The Phase Ib dose exploration phase primarily aims to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT). The Phase II expansion phase involves induction therapy using at least four cycles of Linperlisib at RP2D in combination with the VRD regimen. After completing four cycles of induction therapy, patients eligible for autologous hematopoietic stem cell transplantation (ASCT) will undergo the procedure. For patients whose therapeutic evaluation results in PD (progressive disease) or SD (stable disease), alternative treatment regimens will be considered based on their condition. After successful transplantation, 2-4 cycles of the original induction regimen will be used for consolidation therapy.The primary objective is to evaluate the proportion of patients achieving a very good partial response (VGPR) after four cycles of induction therapy with the Linperlisib combined VRD regimen.
1.Patients must be newly diagnosed with active multiple myeloma. 2. Patients must be between 18 and 65 years old and eligible for autologous hematopoietic stem cell transplantation (ASCT).
Any quantifiable serum monoclonal protein level (typically but not necessarily ≥0.5 g/dL of M-protein), and/or urinary light chain excretion >200 mg/24 hours.
For oligosecretory or non-secretory multiple myeloma (MM), patients must have measurable plasmacytomas >2 cm confirmed by clinical examination or imaging (e.g., MRI, CT scan) or an abnormal free light chain (FLC) ratio (normal value: 0.26-1.65) with an involved FLC level ≥10 mg/dL.
Serum alanine aminotransferase (ALT) ≤3 times the upper limit of normal (ULN).
1. Patients who have previously received anti-myeloma therapy, except for radiotherapy, bisphosphonates, or a single short course of steroids (≤40 mg/day of dexamethasone equivalent for up to 4 days).
Unstable angina or myocardial infarction.
New York Heart Association (NYHA) Class III or IV heart failure.
Uncontrolled angina.
Single group
a combination treatment of Linperlisib and the VRD regimen
DrugSubjects will be administered Linperlisib orally at doses of 40 mg, 60 mg, or 80 mg once daily for 4 consecutive weeks, combined with the VRD regimen at standard doses. Subsequently, during the expansion phase, at least four cycles of Linperlisib at the recommended Phase II dose (RP2D) will be combined with the VRD regimen for induction therapy.
Dose-Limiting Toxicity (DLT)
The primary objective is to determine the recommended Phase II dose (RP2D) of Linperlisib based on dose-limiting toxicity (DLT).
VGPR Rate
The very good partial response (VGPR) rate is evaluated based on the 2016 International Myeloma Working Group (IMWG) criteria.
Complete remission rate
Bone marrow primitive cells \<5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L
Overall survival
The time from the patient's first dose of medication to the time of death from any cause.
Progression-Free Survival (PFS)
The length of time during and after treatment that a patient lives without any signs of disease progression, assessed after completing induction therapy, ASCT, and consolidation therapy.
Incidence of adverse events
Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.
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Fuling Zhou
Lead sponsor
Zhongnan Hospital
Sponsor institution
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