This study is a randomized, open-label, multicenter Phase III clinical trial involving patients with relapsed/refractory multiple myeloma. The estimated total sample size is 260 cases, who will be randomly assigned in a 1:1 ratio to the test group and the control group. The primary objective of the study is to demonstrate the efficacy of TQB2934 for injection compared to the investigator-selected regimen in subjects with relapsed or refractory multiple myeloma (RRMM) by evaluating progression-free survival (PFS).
Voluntarily join this study, sign the Informed Consent Form (ICF), and demonstrate good compliance.
Aged 18 to 75 years old (as of the date of signing the ICF); gender not limited; Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
Expected survival greater than 3 months.
Patients with relapsed or refractory multiple myeloma.
History of other malignancies within 5 years prior to informed consent or concurrent presence of other malignancies. The following exceptions are allowed: other malignancies cured by surgery alone with a disease-free survival (DFS) ≥5 years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the basement membrane)].
Diagnosis of plasma cell leukemia (defined as circulating plasma cells ≥5% in peripheral blood according to standard classification), Waldenström macroglobulinemia, primary light-chain (AL) amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein [M protein], and skin changes), or solitary plasmacytoma.
Receipt of chimeric antigen receptor T-cell (CAR-T), Chimeric Antigen Receptor T-Cell Immunotherapy(CAR-T), Chimeric Antigen Receptor Natural Killer Cells (CAR-NK), or other cellular therapies within 3 months prior to randomization;
Receipt of autologous stem cell transplantation within 3 months prior to randomization;
Parallel
TQB2934 injection
DrugTQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Pomalidomide Capsule
DrugPomalidomide capsules are an immunomodulatory(IMiD).
Selinexor tablets
DrugSelinexor is a selective nuclear export protein inhibitor.
Dexamethasone tablets
DrugDexamethasone tablets are a type of adrenocortical hormone drug.
Progression-free survival (PFS)
The time from randomization to disease progression or death from any cause, whichever occurs first.
Investigator-assessed PFS
The time from randomization to disease progression or death from any cause, whichever comes first.
PFS rates at 6, 12 and 18 months
The proportion of patients who remain free from disease progression or death at 6, 12 and 18 months after randomization.
Overall response rate (ORR)
The proportion of patients with a complete response (CR) or partial response (PR) after treatment.
Very Good Partial Response (VGPR)
The best overall response is defined as the sum proportion of subjects achieving stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). or very good partial response (VGPR).
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