SIL as Maintenance Therapy in Multiple Myeloma

NCT ID: NCT06744894

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2030-01-01

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Maintenance Therapy

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

Group Type EXPERIMENTAL

Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

Intervention Type 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.

Interventions

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Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy

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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Navy General Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Liren Qian

Associate Chief Physician, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Liren Qian, PhD

Role: PRINCIPAL_INVESTIGATOR

Navy General Hospital, Beijing

Central Contacts

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Liren Qian, PhD

Role: CONTACT

Phone: +861066947194

Email: [email protected]

Liren Qian

Role: CONTACT

Other Identifiers

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SIL2024

Identifier Type: -

Identifier Source: org_study_id