RecruitingPhase 3NCT07138209

A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

228 participants

Start Date

Nov 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare the safety and efficacy of QLS32015 with Pd/Sd for the treatment of relapsed or refractory multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a new drug called QLS32015 on its own against standard two-drug combination treatments (pomalidomide + dexamethasone or selinexor + dexamethasone) in people with multiple myeloma — a blood cancer affecting plasma cells — that has returned or stopped responding to previous treatments. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with multiple myeloma that has relapsed (come back) or is refractory (no longer responding to treatment) - You have received at least 3 prior treatment regimens, including a proteasome inhibitor, an immunomodulatory drug (like lenalidomide), and an anti-CD38 antibody (like daratumumab) - You have measurable levels of myeloma in your blood or urine **You may NOT be eligible if...** - You have had fewer than 3 prior lines of therapy - You have significant heart, liver, or kidney disease - You are allergic to any of the study medications - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQLS32015

QLS32015 will be administered subcutaneously.

DRUGPomalidomide

Pomalidomide will be administered orally.

DRUGSelinexor

Selinexor will be administered orally.

DRUGDexamethasone

Dexamethasone will be administered orally


Locations(1)

National Clinical Research Center for Blood Diseases

Tianjin, Tianjin Municipality, China

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NCT07138209


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