Recruiting NCT07018050
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS32015, Pomalidomide, Dexamethasone, QL2109 or Daratumumab.
- Who it may be relevant to
- Registry conditions: Relapsed or Refractory Multiple Myeloma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Overview
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.
Interventions
- Drug QLS32015
QLS32015 will be administered subcutaneously - Drug Pomalidomide
Pomalidomide will be self-administered as a single dose orally - Drug Dexamethasone
Dexamethasone will be administered orally or intravenously - Drug QL2109 or Daratumumab
QL2109 or Daratumumab will be administered subcutaneously. - Drug Bortezomib
Bortezomib will be administered subcutaneously - Drug Lenalidomide
Lenalidomide will be self-administered as a single dose orally
Primary outcome measures
- ORR (Partial Response [PR] or Better) [Time frame: Up to 2 years]
- Overall Minimal Residual Disease (MRD) [Time frame: Up to 2 years]
Secondary outcome measures (1)
- Progression-Free Survival (PFS) [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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);
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Institute of Hematology & Blood Diseases Hospital — Tianjin
Identifiers
NCT: NCT07018050 · QLS32015-202