Tests QLS4131 injection in adults with relapsed or refractory multiple myeloma
Tests QLS4131 injection in adults with myeloma that returned or did not respond.
Plain-language title generated from the registry record
Registry title: A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 1
Where in China
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Qilu Pharmaceutical Co., Ltd.
- Trial code
- NCT06500507
- Record updated
- 15 July 2024
- Original description
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.Read full original descriptionShow less
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS4131 Injection in Patients With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.
Inclusion: 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.
Exclusion: Known hypersensitivity to any of the ingredients of this product; 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; Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.