Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma
A Randomized, Open-Label, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2934 Injection Versus Investigator-Selected Regimens in Patients With Relapsed/Refractory Multiple Myeloma
1 other identifier
interventional
260
1 country
49
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 multiple-myeloma
Started Jun 2026
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 1, 2030
May 6, 2026
February 1, 2026
2.5 years
April 29, 2026
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
The time from randomization to disease progression or death from any cause, whichever occurs first.
Baseline up to 5 years
Secondary Outcomes (13)
Investigator-assessed PFS
Baseline up to 5 years
PFS rates at 6, 12 and 18 months
From baseline to 18 months
Overall response rate (ORR)
Baseline up to 5 years
Very Good Partial Response (VGPR)
Baseline up to 5 years
Complete Response (CR) Rate
Baseline up to 5 years
- +8 more secondary outcomes
Study Arms (2)
TQB2934 injection
EXPERIMENTALTQB2934 injection, 28 days as a treatment cycle.
Selinexor and Dexamethasone or Pomalidomide Dexamethasone
ACTIVE COMPARATORSelinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Interventions
Pomalidomide capsules are an immunomodulatory(IMiD).
Selinexor is a selective nuclear export protein inhibitor.
Dexamethasone tablets are a type of adrenocortical hormone drug.
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Eligibility Criteria
You may qualify if:
- 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.
- During or after the most recent treatment, there is evidence of disease progression or failure to achieve remission after the last line of treatment。
- Measurable disease at screening.
- Adequate organ function as indicated by laboratory tests meeting the criteria. 8. Women of childbearing potential must agree to use effective contraception during the study and for 12 months after the last dose of study treatment, and agree not to donate eggs for reproduction during this period. Must not be breastfeeding and must have a negative serum or urine pregnancy test within 7 days prior to enrollment. Men who have not had a vasectomy and their female partners of childbearing potential should also agree to use effective contraception during the study and for 12 months after the last dose of study treatment, and agree not to donate sperm during this period.
You may not qualify if:
- 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:
- \) 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; 2) Receipt of autologous stem cell transplantation within 3 months prior to randomization; 3) Receipt of allogeneic stem cell transplantation within 6 months prior to randomization; subjects must have discontinued all immunosuppressive therapy for ≥6 weeks and have no signs or symptoms of graft-versus-host disease (GVHD); 4) Receipt of molecular targeted therapy, investigational drugs, or invasive investigational medical devices within 3 weeks or 5 drug half-lives (whichever is shorter) prior to randomization; 5) Receipt of monoclonal antibodies, bispecific antibodies, chemotherapy, etc., within 3 weeks prior to randomization; 6) Receipt of proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), localized radiotherapy, palliative radiotherapy, or Chinese patent medicines with antitumor indications approved by the National Medical Products Administration (NMPA) within 2 weeks prior to randomization.
- \. 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) 14. Significant cardiovascular disease. 15. Neurological or psychiatric disorders. 16. Pulmonary diseases, including any of the following:
- Current or prior non-infectious pneumonitis requiring corticosteroid treatment (including but not limited to acute respiratory distress syndrome, acute hypersensitivity pneumonitis, drug-related pneumonitis, bronchospasm, acute interstitial pneumonitis, idiopathic pulmonary fibrosis, etc.);
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233004, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
Beijing Chao-Yang Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020, China
Beijing Jishuitan Hospital,Capital Medical University
Beijing, Beijing Municipality, 100020, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The Southwest Hospital of Amu
Chongqing, Chongqing Municipality, 400038, China
Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, 510062, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524023, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
Cangzhou People'S Hospital
Cangzhou, Hebei, 061000, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000, China
The Second Hospital of Hebeimedical University
Shijiazhuang, Hebei, 050000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Henan Provincial People'S Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital Of Zhengzhou University
Zhengzhou, Henan, 451191, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412007, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221004, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330038, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110000, China
The Second Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710048, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256600, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）
Jinan, Shandong, 250021, China
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, 250117, China
Jining No.1 People'S Hospital
Jining, Shandong, 272111, China
Qingdao Municipal Hospital
Qingdao, Shandong, 266011, China
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233, China
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 46000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 30000, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Tianjin Union Medical Center
Tianjin, Tianjin Municipality, 300121, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830000, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650000, China
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital of Ningbo Universty
Ningbo, Zhejiang, 315000, China
Ningbo No.2 Hospitai
Ningbo, Zhejiang, 315016, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2026
First Posted
May 6, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2030
Last Updated
May 6, 2026
Record last verified: 2026-02