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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
260
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Pomalidomide capsules are an immunomodulatory(IMiD).
Selinexor is a selective nuclear export protein inhibitor.
Progression-free survival (PFS)
The time from randomization to disease progression or death from any cause, whichever occurs first.
Time frame: Baseline up to 5 years
Investigator-assessed PFS
The time from randomization to disease progression or death from any cause, whichever comes first.
Time frame: Baseline up to 5 years
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.
Time frame: From baseline to 18 months
Overall response rate (ORR)
The proportion of patients with a complete response (CR) or partial response (PR) after treatment.
Time frame: Baseline up to 5 years
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).
Time frame: Baseline up to 5 years
Complete Response (CR) Rate
The percentage of evaluable subjects who achieve complete response (CR).
Time frame: Baseline up to 5 years
Duration of remission (DOR)
The time from the first onset of objective response to the first documentation of disease progression or death from any cause, whichever occurs first.
Time frame: Baseline up to 5 years
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Dexamethasone tablets are a type of adrenocortical hormone drug.
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, China
Beijing Jishuitan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, China
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)
Lanzhou, Gansu, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
...and 39 more locations
Time to first remission (TTR)
The time from randomization to the first achievement of objective response.
Time frame: Baseline up to 5 years
Negative rate of minimal residual disease (MRD)
The proportion of subjects achieving MRD negativity.
Time frame: Baseline up to 5 years
Overall survival (OS)
Time from randomization to death.
Time frame: From randomization to death, the estimated evaluation period is up to 5 years
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame: From randomization to 2 months after the last dose
Peak concentration (Cmax)
Maximum plasma drug concentration.
Time frame: Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, after dose of Cycle 2 Day 1, Cycle 6 Day 1,Last visit (up to 5 years), each cycle is 28 days.
Anti-drug antibody (ADA) positive rate
The proportion of evaluable subjects with positive test results for anti-drug antibody (ADA).
Time frame: Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.
Nab positive rate
The percentage of evaluable subjects with positive neutralizing antibody (NAB) test results in all evaluable subjects.
Time frame: Before Pre-dose, before dose of Cycle 1 Day 1, Cycle 2 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Last visit (up to 5 years) and 30 days after the last administration each, each cycle is 28 days.