Recruiting NCT07138209
A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS32015, Pomalidomide, Selinexor, Dexamethasone.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
Overview
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.
Interventions
- Drug QLS32015
QLS32015 will be administered subcutaneously. - Drug Pomalidomide
Pomalidomide will be administered orally. - Drug Selinexor
Selinexor will be administered orally. - Drug Dexamethasone
Dexamethasone will be administered orally
Primary outcome measures
- Progression-free Survival (PFS) [Time frame: Up to 4 years]
Secondary outcome measures (7)
- Overall Response (Partial Response [PR] or Better) [Time frame: Up to 4 years]
- Very Good Partial Response (VGPR) or Better Response [Time frame: Up to 4 years]
- Complete Response (CR) or Better Response [Time frame: Up to 4 years]
- Duration of Response (DOR) [Time frame: Up to 4 years]
- Minimal Residual Disease (MRD) Negativity [Time frame: Up to approximately 4 years]
- Number of Participants with Adverse Events (AEs) by Severity [Time frame: Up to 4 years]
- Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) [Time frame: Baseline up to 4 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- National Clinical Research Center for Blood Diseases — Tianjin
Identifiers
NCT: NCT07138209 · QLS32015-301