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A Phase Ib/II Clinical Study on the Application of Linperlisib Combined with the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma
Sponsor: Fuling Zhou
Summary
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.
Official title: A Single-Arm, Multicenter, Open-Label Phase Ib/II Clinical Study on the Application of Linperlisib Plus the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2025-02
Completion Date
2027-10
Last Updated
2025-01-29
Healthy Volunteers
No
Conditions
Interventions
a combination treatment of Linperlisib and the VRD regimen
Subjects 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.
Locations (3)
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
Xianning Central Hospital
Xianning, Hubei, China