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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2934 injection | Experimental | TQB2934 injection, 28 days as a treatment cycle. |
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| Selinexor and Dexamethasone or Pomalidomide Dexamethasone | Active Comparator | Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2934 injection | Drug | TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | The time from randomization to disease progression or death from any cause, whichever occurs first. | Baseline up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed PFS | The time from randomization to disease progression or death from any cause, whichever comes first. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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.
History of prior anticancer treatment, including but not limited to:
Previously refractory to control group drugs, or with contraindications, life-threatening allergic reactions, or intolerance to previous treatments.
Receipt of systemic corticosteroids at a cumulative dose ≥140 mg prednisone (or equivalent) within 2 weeks prior to randomization. Topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids are excluded from the cumulative dose calculation (see Appendix for dose conversion).
Toxicities from prior antitumor therapy have not recovered to baseline or ≤ Grade 1, except for Grade 2 alopecia, non-clinically significant and asymptomatic laboratory abnormalities, and hypothyroidism stabilized by hormone replacement therapy, as judged by the investigator to pose no safety risk.
History of Grade ≥3 cytokine release syndrome (CRS) associated with any T-cell redirecting therapy (e.g., CD3-redirecting therapies or CAR-T cell therapy).
Presence of conditions affecting intravenous infusion or blood collection, dysphagia, chronic diarrhea, intestinal obstruction, or other active gastrointestinal dysfunction that may interfere with drug administration or absorption.
Known central nervous system (CNS) involvement of multiple myeloma (MM), or clinical signs/symptoms suggestive of leptomeningeal involvement. If either is suspected, both brain MRI and lumbar puncture cytology must be negative.
Major surgery, significant traumatic injury, or planned major surgery during the study treatment period within 4 weeks prior to randomization, or presence of non-healed wounds or fractures (major surgery defined as Grade ≥3 according to the 2022 national surgical classification catalogue).
Any severe (≥ CTCAE Grade 3) bleeding or hemorrhagic event within 6 months prior to randomization.
Arterial or venous thrombotic events within 6 months prior to randomization, including cerebrovascular events (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, or any other serious thromboembolism (implantable venous port- or catheter-related thrombosis and superficial thrombosis are not considered "serious").
Active hepatitis or decompensated cirrhosis (Child-Pugh Class B or C)
Significant cardiovascular disease.
Neurological or psychiatric disorders.
Pulmonary diseases, including any of the following:
Active or uncontrolled infections (≥ CTCAE Grade 2), including bacterial, fungal, or viral infections, such as active pneumonia/pulmonary infection, syphilis, tuberculosis, or Corona Virus Disease 2019 (COVID-19). Subjects with positive Cytomegalovirus (CMV) DNA or Epstein-Barr virus (EBV) plasma DNA during screening are not eligible.
Current or prior autoimmune diseases requiring systemic treatment. Subjects with hypothyroidism on stable replacement therapy, well-controlled type 1 diabetes, or skin diseases not requiring systemic therapy (e.g., vitiligo, psoriasis) are eligible.
History of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency disorders.
Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).
Known history of hypersensitivity to humanized monoclonal antibodies, or known allergy, hypersensitivity, or intolerance to any component of the investigational product.
Any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that, in the investigator's opinion, may increase the risk associated with study participation or interfere with interpretation of study results.
Investigator considers that the subject is likely to have poor compliance with study participation.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liu, Doctor | Contact | 18286006744 | liu.peng@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical University | Bengbu | Anhui | 233004 | China |
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| Pomalidomide Capsule | Drug | Pomalidomide capsules are an immunomodulatory(IMiD). |
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| Selinexor tablets | Drug | Selinexor is a selective nuclear export protein inhibitor. |
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| Dexamethasone tablets | Drug | Dexamethasone tablets are a type of adrenocortical hormone drug. |
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| From baseline to 18 months |
| Overall response rate (ORR) | The proportion of patients with a complete response (CR) or partial response (PR) after treatment. | 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). | Baseline up to 5 years |
| Complete Response (CR) Rate | The percentage of evaluable subjects who achieve complete response (CR). | 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. | Baseline up to 5 years |
| Time to first remission (TTR) | The time from randomization to the first achievement of objective response. | Baseline up to 5 years |
| Negative rate of minimal residual disease (MRD) | The proportion of subjects achieving MRD negativity. | Baseline up to 5 years |
| Overall survival (OS) | Time from randomization to death. | 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). | From randomization to 2 months after the last dose |
| Peak concentration (Cmax) | Maximum plasma drug concentration. | 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). | 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. | 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. |
| The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230022 | China |
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| Beijing Chao-Yang Hospital,Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
| Beijing Jishuitan Hospital,Capital Medical University | Beijing | Beijing Municipality | 100020 | China |
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| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
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| The Southwest Hospital of Amu | Chongqing | Chongqing Municipality | 400038 | China |
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| Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital) | Lanzhou | Gansu | 730000 | China |
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| Lanzhou University Second Hospital | Lanzhou | Gansu | 730030 | China |
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| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510062 | China |
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| Zhujiang Hospital of Southern Medical University | Guangzhou | Guangdong | 510280 | China |
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| Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong | 524023 | China |
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| The First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530000 | China |
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| The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | 550001 | China |
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| Cangzhou People'S Hospital | Cangzhou | Hebei | 061000 | China |
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| Affiliated Hospital of Chengde Medical University | Chengde | Hebei | 067000 | China |
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| The Second Hospital of Hebeimedical University | Shijiazhuang | Hebei | 050000 | China |
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| The Second Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150086 | China |
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| Luoyang Central Hospital | Luoyang | Henan | 471000 | China |
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| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
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| Henan Provincial People'S Hospital | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital Of Zhengzhou University | Zhengzhou | Henan | 451191 | China |
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| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
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| Zhuzhou Central Hospital | Zhuzhou | Hunan | 412007 | China |
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| Zhongda Hospital Southeast University | Nanjing | Jiangsu | 210009 | China |
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| Jiangsu Province Hospital | Nanjing | Jiangsu | 210029 | China |
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| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221004 | China |
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| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| Jiangxi Provincial People's Hospital | Nanchang | Jiangxi | 330038 | China |
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| Shengjing Hospital of China Medical University | Shenyang | Liaoning | 110000 | China |
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| The Second Affiliated Hospital Of Xi'an Jiaotong University | Xi'an | Shaanxi | 710004 | China |
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| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | 710048 | China |
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| Binzhou Medical University Hospital | Binzhou | Shandong | 256600 | China |
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| Shandong Provincial Hospital Affiliated to Shandong First Medical University(Shandong Provincial Hospital) | Jinan | Shandong | 250021 | China |
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| Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital) | Jinan | Shandong | 250117 | China |
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| Jining No.1 People'S Hospital | Jining | Shandong | 272111 | China |
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| Qingdao Municipal Hospital | Qingdao | Shandong | 266011 | China |
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| ZhongShan Hospital Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | 200233 | China |
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| Heping Hospital Affiliated to Changzhi Medical College | Changzhi | Shanxi | 46000 | China |
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| Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi | 30000 | China |
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| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Chengdu | Sichuan | 610072 | China |
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| The Affiliated Hospital of Southwest Medical University | Luzhou | Sichuan | 646000 | China |
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| Tianjin Union Medical Center | Tianjin | Tianjin Municipality | 300121 | China |
| People's Hospital of Xinjiang Uygur Autonomous Region | Ürümqi | Xinjiang | 830000 | China |
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| The First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
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| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310000 | China |
| The First Affiliated Hospital of Ningbo Universty | Ningbo | Zhejiang | 315000 | China |
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| Ningbo No.2 Hospitai | Ningbo | Zhejiang | 315016 | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
| C585161 | selinexor |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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