Qilu Pharmaceutical Initiates Phase III Clinical Trial of QLS32015 Injection for Relapsed/Refractory Multiple Myeloma

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that Qilu Pharmaceutical Co., Ltd. has initiated a randomized, controlled, multicenter, open-label Phase III study to evaluate the efficacy and safety of injectable QLS32015 as a monotherapy compared to investigator-selected regimens in subjects with relapsed/refractory multiple myeloma (RRMM). The clinical trial registration number is CTR20253381, and the initial information disclosure date was August 21, 2025.

The drug is in the form of an injection, with a specification of 0.25mg/vial. The dosage is 54 μg/kg, administered subcutaneously once every two weeks. The main purpose of this trial is to evaluate the progression-free survival (PFS) of QLS32015 for injection as a monotherapy and the investigator's choice regimen in subjects with relapsed or refractory multiple myeloma who have previously received ≥3 lines of therapy.

QLS32015 for Injection is a biological product, indicated for multiple myeloma. Multiple myeloma is a malignant plasma cell proliferative disorder, with main symptoms including bone pain, anemia, and renal dysfunction. Diagnosis relies on bone marrow aspiration, blood and urine protein tests, etc.

The primary endpoint of this trial includes progression-free survival (PFS) assessed by the Independent Review Committee (IRC); secondary endpoints include PFS assessed by investigators, minimal residual disease (MRD)-negative rate, overall response rate (ORR) assessed by both IRC and investigators, as well as safety indicators such as adverse events (AE).

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 228 participants.

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Editor: Xiaolang Express