QLS32015 versus pomalidomide+dexamethasone or selinexor+dexamethasone for relapsed or refractory multiple myeloma

A Phase 3 Randomized Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma

This will see if QLS32015 alone controls disease and is safe compared with pomalidomide+dexamethasone or selinexor+dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least three prior treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07138209 on ClinicalTrials.gov

What this trial studies

This Phase 3, interventional trial randomly assigns adults with relapsed or refractory multiple myeloma to receive either QLS32015 monotherapy or one of two comparator regimens (pomalidomide+dexamethasone or selinexor+dexamethasone). Eligible participants must have measurable disease and have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. The study compares safety and efficacy outcomes using standard myeloma response criteria and monitors adverse events throughout treatment. Key endpoints include response rates, progression-free survival, and tolerability in this heavily pretreated population.

Who should consider this trial

Good fit: Adults (≥18 years) with relapsed or refractory multiple myeloma who have measurable disease and have received at least three prior lines of therapy including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody are the intended participants.

Not a fit: Patients with active plasma cell leukemia, systemic light-chain amyloidosis, known hypersensitivity to study drug ingredients, or uncontrolled severe psychiatric or medical conditions are unlikely to benefit or be eligible for this protocol.

Why it matters

Potential benefit: If successful, QLS32015 could offer a new single-drug treatment option that helps control disease for patients whose myeloma has returned after multiple prior therapies.

How similar studies have performed: Pomalidomide+dexamethasone and selinexor+dexamethasone have shown activity in heavily pretreated myeloma, while QLS32015 is an experimental agent with limited published phase 3 data to date.

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 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:

* 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.

Where this trial is running

Tianjin, Tianjin Municipality

• National Clinical Research Center for Blood Diseases — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Gang An, Professor

Conditions: Relapsed or Refractory Multiple Myeloma