Status:
NOT_YET_RECRUITING
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Qilu Pharmaceutical Co., Ltd.
Conditions:
Relapsed or Refractory Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT07138209
Start Date
October 1 2025
End Date
December 1 2029
Last Update
August 24 2025
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