QLS32015 versus pomalidomide+dexamethasone or selinexor+dexamethasone for relapsed or refractory multiple myeloma
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
Run by Qilu Pharmaceutical Co., Ltd. · NCT07138209 · Data updated 2026-11-12
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 | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 228 (estimated) |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | November 7, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2029 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT07138209 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
National Clinical Research Center for Blood Diseases
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Gang An, Professor
- Email: angang@ihcams.ac.cn
- Phone: 008613502181109
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AZD4045 in Relapsed or Refractory Multiple Myeloma
This study tests AZD4045 alone and with daratumumab and aldesleukin in adults whose multiple myeloma has returned or stopped responding to treatment.
-
A new treatment approach for relapsed or refractory multiple myeloma in adults
This study tests if IBI3003 works better than the investigator's choice treatment for adults whose multiple myeloma has returned or persisted after prior therapy.
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O&D-001 CAR‑T injection for relapsed or refractory multiple myeloma
This trial will test a CAR‑T injection called O&D‑001 that targets BCMA and GPRC5D in adults with relapsed or refractory multiple myeloma who have had at least two prior therapies.
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F182112 given with other drugs for relapsed or refractory multiple myeloma
This trial will test whether F182112, given with different drug regimens, helps people whose multiple myeloma has returned or stopped responding to prior treatments.
-
mRNA-2808 for relapsed or refractory multiple myeloma
This will test whether mRNA-2808 is safe and tolerable for people with relapsed or refractory multiple myeloma who have already received standard therapies.
-
QLS32015 combination therapy for relapsed or refractory multiple myeloma
This study will test whether the injected drug QLS32015 combined with approved myeloma medicines helps people whose multiple myeloma has come back or not responded to previous treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.