SIL as Maintenance Therapy in Multiple Myeloma

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

Drug

Patients were treated by Selinexor (40mg po qw d1-28) combined with Ixazomib (4mg po on days 1, 8, and 15 in 28-day cycles) and Lenalidomide(10mg po qd d1-21) as Maintenance Therapy.

Primary outcomes

PFS

Time frame: 2 years

PFS was defined as the time from study entry until disease progression

Secondary outcomes

EFS

Time frame: 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

Time frame: 2 years

OS was defined as the time from treatment initiation to death by any cause.

Study contacts

Contact information is provided by the study sponsor or research team.

Liren Qian

CONTACT

Liren Qian, PhD

CONTACT

[email protected]

+861066947194

Sponsors and collaborators

Lead sponsor

Navy General Hospital, Beijing

Other

Registry information

Official study title

Selinexor Combined With Ixazomib and Lenalidomide as Maintenance Therapy in Patients With Multiple Myeloma

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2030
First posted: Dec 20, 2024
Registry last updated: Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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