Tests QLS32015 with other medicines in adults with relapsed or refractory multiple myeloma
Tests QLS32015 with other medicines in adults whose myeloma returned or stopped responding.
Plain-language title generated from the registry record
Registry title: Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Key facts
- Where
- Tianjin, ChinaSee the site
- Phase
- Phase 2
Where in China
- Institute of Hematology & Blood Diseases HospitalTianjin, ChinaTaking people
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
- NCT07018050
- Record updated
- 8 June 2026
- Original description
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.Read full original descriptionShow less
A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
The purpose of the study is to compare the efficacy of QLS32105 (SC) in combination with Pomalidomide, and QLS32105 (SC) in combination with QL2109 or Daratumumab, and QLS32105 (SC) in combination with QL2109 or Daratumumab and Pomalidomide, and QLS32105(SC) in combination with Bortezomib and Lenalidomide.
Inclusion: Diagnosis of multiple myeloma confirmed according to the 2016 International Myeloma Working Group (IMWG) diagnostic criteria; Prior therapy: Relapsed, progressed, or intolerant to ≥1 prior line of anti-multiple myeloma therapy; Measurable disease at screening, defined by at least one of the following:; Serum M-protein ≥1.0 g/dL (10 g/L); Urine M-protein ≥200 mg/24 hours; Serum immunoglobulin free light chain ≥10 mg/dL (100 mg/L) with an abnormal serum immunoglobulin κ/λ free light chain ratio.
Exclusion: Prior anti-myeloma therapies within the specified timeframes before enrollment:; Previous treatment with GPRC5D-targeted therapy; Genetically modified adoptive cell therapy (e.g., chimeric antigen receptor T-cell [CAR-T], natural killer [NK] cell therapy) within 3 months; Targeted therapy, investigational drugs, or invasive investigational medical devices within 21 days or 5 half-lives (whichever is longer); Bispecific antibody therapy for multiple myeloma within 21 days or 5 half-lives (whichever is longer); Cytotoxic therapy or monoclonal antibodies within 21 days; Proteasome inhibitor therapy within 14 days; Immunomodulatory drug therapy within 7 days; Radiotherapy within 14 days (except low-dose palliative radiation [10-30 Gy]); Prior intolerance to Pomalidomide (applies to treatment cohorts containing Pomalidomide); Prior intolerance to Bortezomib (applies to treatment cohorts containing bortezomid); Prior intolerance to Lenalidomide (applies to treatment cohorts containing Lenalidomide); Prior intolerance to Daratumumab (applies to treatment cohorts containing Daratumumab); History of Grade 3 or higher cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting technologies or CAR-T cell therapy).