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RECRUITINGPHASE3

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

NCT07138209•Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥18 years old, regardless of gender.
•Subjects should be willing and able to comply with the study schedule and protocols.
•Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria.Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal.
•Received at least 3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).

Exclusion Criteria

•Known hypersensitivity to any of the ingredients of this product.
•Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.
•Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
•Disease is considered refractory to pomalidomide and selinexor.

Locations (1)

National Clinical Research Center for Blood Diseases

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

November 7, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2029

Last Updated

February 27, 2026

Enrollment

228

ESTIMATED participants

Conditions

Relapsed or Refractory Multiple Myeloma

Interventions

QLS32015

DRUG

Pomalidomide

DRUG

Selinexor

DRUG

Dexamethasone

DRUG

Contacts

Gang An, Professor

CONTACT

008613502181109 angang@ihcams.ac.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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