SIL as Maintenance Therapy in Multiple Myeloma

December 17, 2024 updated by: Liren Qian, Navy General Hospital, Beijing

Selinexor Combined With Ixazomib and Lenalidomide as Maintenance Therapy in Patients With 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Liren Qian

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maintenance Therapy
Patients were treated by Selinexor combined with Ixazomib and Lenalidomide as Maintenance Therapy
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 2 years
PFS was defined as the time from study entry until disease progression
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
OS
Time Frame: 2 years
OS was defined as the time from treatment initiation to death by any cause.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Investigators

  • Principal Investigator: Liren Qian, PhD, Navy General Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 17, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIL2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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