A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT07138209
Last Updated: 2025-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
228 participants
INTERVENTIONAL
2025-10-31
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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QLS32015
Participants will receive teclistamab monotherapy.
QLS32015
QLS32015 will be administered subcutaneously.
Pomalidomide, Dexamethasone (Pd) or Selinexor and Dexamethasone (Sd)
Participants will receive either Pd or Sd based on principal investigator's choice.
Pomalidomide
Pomalidomide will be administered orally.
Selinexor
Selinexor will be administered orally.
Dexamethasone
Dexamethasone will be administered orally
Interventions
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QLS32015
QLS32015 will be administered subcutaneously.
Pomalidomide
Pomalidomide will be administered orally.
Selinexor
Selinexor will be administered orally.
Dexamethasone
Dexamethasone will be administered orally
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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QLS32015-301
Identifier Type: -
Identifier Source: org_study_id
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