SIL as Maintenance Therapy in Multiple Myeloma

Phase 2

Not yet recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

• Registration Number: NCT06744894
• Lead Sponsor: Navy General Hospital, Beijing

Brief Summary

The goal of this phase 2 trial is to test the safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma.

Detailed Description

The investigators will evaluate safety and efficacy of selinexor combined with ixazomib and lenalidomide as maintenance therapy in patients with multiple myeloma post complete remission. Event-free survival (EFS), progression-free survival (PFS), overall survival (OS), adverse events (AEs) will be assessed.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-01
• Primary Completion: 2028-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Pathologically confirmed Multiple Myeloma according World Health Organization (WHO) classification;
• Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
• Patient must understand and voluntarily sign an ICF prior to any study-specific assessments/procedures being conducted;
• Patient is willing and able to adhere to the study visit schedule and other protocol requirements;
• Documented response to ASCT (PR, VGPR, CR/stringent complete response [sCR]) according to IMWG criteria.

Exclusion Criteria

• Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment.
• Any instability of systemic disease, including but not limited to severe cardiac, liver, kidney, or metabolic disease need therapy.
• Pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Maintenance Therapy	Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy	Patients were treated by Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

Primary Outcome Measures

Name	Time	Method
PFS	2 years	PFS was defined as the time from study entry until disease progression

Secondary Outcome Measures

Name	Time	Method
EFS	2 years	EFS was defined as the time from treatment initiation to progression, relapse, new treatment, or death by any cause, whichever occurred first.
OS	2 years	OS was defined as the time from treatment initiation to death by any cause.