Actively Recruiting
A Multicenter, Open-Label Phase II Study to Evaluate QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-06-08
160
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of QLS32015 in combination with various other drugs for treating relapsed or refractory multiple myeloma. This phase II study compares four different combinations involving QLS32015 with Pomalidomide, QL2109 or Daratumumab, and Bortezomib with Lenalidomide. The goal is to understand how these combinations work in patients who have received prior treatment for multiple myeloma. Participants receive QLS32015 through subcutaneous injections combined with other drugs depending on the study group. Pomalidomide and Lenalidomide are taken orally by the participants themselves, while drugs like QL2109, Daratumumab, and Bortezomib are given by injection. Dexamethasone may be given orally or intravenously as a pretreatment medication. These treatments are administered as part of different study arms to compare their effects. During the study, participants will be regularly assessed for their response to the treatments, including measuring the overall response rate and minimal residual disease up to two years. Other evaluations include progression-free survival. The study is open-label and non-randomized, meaning all participants and researchers know which treatments are given. The total time for outcome measurement extends up to two years, allowing for thorough monitoring of safety and effectiveness.
CONDITIONS
Brief Title
Phase II Study of QLS32015 Combination Therapy in the Treatment of Multiple Myeloma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with multiple myeloma according to 2016 International Myeloma Working Group criteria
- Relapsed, progressed, or intolerant to at least one prior line of anti-multiple myeloma therapy
- Measurable disease at screening defined by one of: serum M-protein ≥1.0 g/dL, urine M-protein ≥200 mg/24 hours, or serum immunoglobulin free light chain ≥10 mg/dL with abnormal kappa/lambda ratio
- Adults aged 18 years or older
You will not qualify if you...
- History of Grade 3 or higher cytokine release syndrome related to any T-cell redirecting therapy
- Prior treatment with GPRC5D-targeted therapy
- Genetically modified adoptive cell therapy within 3 months
- Use of targeted therapy, investigational drugs, or invasive devices within 21 days or 5 half-lives
- Bispecific antibody therapy within 21 days or 5 half-lives
- 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
- Prior intolerance to Pomalidomide, Bortezomib, Lenalidomide, or Daratumumab depending on treatment cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive combination drug therapy including QLS32015 injections and other medications depending on their treatment group.
Regular visits for drug administration and monitoring during treatment
Trial Site Locations
Total: 1 location
1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China
Actively Recruiting
Research Team
G
Gang An, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here