NCT06799676

A Phase Ib/II Clinical Study on the Application of Linperlisib Combined with the VRD Regimen in Newly Diagnosed Patients with Multiple Myeloma

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: Fuling Zhou · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Newly Diagnosed Multiple Myeloma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-08-01
• Completion: 2027-10-01
• First posted: 2025-01-29
• Last updated: 2025-01-29

Locations

3 sites across 1 country: China