NCT07138209 A Study Comparing QLS32015 Monotherapy Versus Pomalidomide, Dexamethasone (Pd) or Selinexor, Dexamethasone (Sd) in Participants With Relapsed or Refractory Multiple Myeloma
| NCT ID | NCT07138209 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Relapsed or Refractory Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 228 participants |
| Start Date | 2025-11-07 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 228 participants in total. It began in 2025-11-07 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07138209 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07138209 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 228 participants.
Is NCT07138209 currently recruiting?
Yes, NCT07138209 is actively recruiting participants. Contact the research team at angang@ihcams.ac.cn for enrollment information.
Where is the NCT07138209 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07138209 clinical trial?
NCT07138209 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 228 participants.