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
Inclusion Criteria4
- 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 Criteria4
- 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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07138209
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