A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
QLS32015: QLS32015 will be administered subcutaneously.
Pomalidomide: Pomalidomide will be administered orally.
Selinexor: Selinexor will be administered orally.
Dexamethasone: Dexamethasone will be administered orally
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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 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.
Primary outcome measure(s)
Progression-free Survival (PFS) — Up to 4 years PFS is defined as the time from the date of randomization to the date of first documented disease progression, as defined in the International myeloma working group (IMWG) 2016 response criteria, or death due to any cause, whichever occurs first.
Trial sites (1)
Facility
City
Region
Status
National Clinical Research Center for Blood Diseases
Tianjin
Tianjin Municipality
Recruiting
More Qilu Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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