Compares QLS32015 with standard drug combinations in relapsed or refractory multiple myeloma
Compares QLS32015 alone with pomalidomide or selinexor plus dexamethasone in adults with myeloma.
Plain-language title generated from the registry record
Registry title: A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 3
Where in China
- National Clinical Research Center for Blood DiseasesTianjin, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Pharmaceutical Co., Ltd.
- Trial code
- NCT07138209
- Record updated
- 22 May 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
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.
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 0.5 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; 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; Diagnosis of active plasma cell leukemia or systemic light chain amyloidosis.