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Multiple MyelomaPhase 3NCT07569757

Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

A Phase 3 study testing TQB2934 injection, Pomalidomide Capsule and Selinexor tablets in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 49 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
TQB2934 injection, Pomalidomide Capsule and Selinexor tablets
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
49 sitesChina
Study dates
Jun 2026to Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.

Who cannot join

  • 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;
  • Receipt of autologous stem cell transplantation within 3 months prior to randomization;
  • 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);
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  • 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;
  • Receipt of monoclonal antibodies, bispecific antibodies, chemotherapy, etc., within 3 weeks prior to randomization;
  • 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)
  • Significant cardiovascular disease.
  • Neurological or psychiatric disorders.
  • 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.);
  • Known or suspected chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) <60% of predicted.
  • 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.

Trial locations and contacts

49 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Peng Liu, Doctor contact

18286006744

liu.peng@zs-hospital.sh.cn

49 sites in 1 country

China49 sites

  • Beijing Chao-Yang Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Beijing Jishuitan Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100020

    Li Bao, Doctor, 13010837430, baoli@jst-hosp.com.cn

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233004

    Jiajia Li, Doctor, 13955207283, 4119469@qq.com

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256600

    Na Gao, Doctor, 15966356316, gn2882155@163.com

  • Cangzhou People'S Hospital

    Cangzhou, Hebei, 061000

    Hongmei Ma, Bachelor, 18031798229, mhm-sspc@163.com

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

    Xin Li, Doctor, 13808418932, 972978226@qq.com

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi, Shanxi, 46000

    Xuliang Shen, Doctor, 13015365546, shenxlcyp@sohu.com

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei, 067000

    Zhihua Zhang, Master, 15633142905, zzhangzhihua@163.com

  • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

    Xiaobing Huang, Doctor, 18981838236, hxb_trial@163.com

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400010

    Li Yang, Doctor, 18623578818, 2664486657@qq.com

  • The Southwest Hospital of Amu

    Chongqing, Chongqing Municipality, 400038

    Shuangnian Xu, Doctor, 13650596553, xushuangnian@163.com

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

    Jie Xiao, Doctor, 13826426842, xiaojie01981@126.com

  • Sun Yat-Sen University Cancer Center

    Guangzhou, Guangdong, 510062

    Zhongjun Xia, Doctor, 13602713223, xiazj@sysucc.org.cn

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

    Yanjie He, Doctor, 13631381275, hyjgzh2006@163.com

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550001

    Jie Xiong, Doctor, 18786687021, 929438808@qq.com

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150086

    Wei Wang, Doctor, 13604880743, ww0453@163.com

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

    Jian Ge, Doctor, 13064587120, gejian52@163.com

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）

    Jinan, Shandong, 250021

    Xiangxiang Zhou, Doctor, 15866695595, Zhouxx90@126.com

  • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)

    Jinan, Shandong, 250117

    Zengjun Li, Doctor, 13642138692, zengjunli@163.com

  • Jining No.1 People'S Hospital

    Jining, Shandong, 272111

    Haiguo Zhang, Master, 13666374406, 149184728@qq.com

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650000

    Mingxia Shi, Doctor, 13888060581, shmxia2002@sina.com

  • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)

    Lanzhou, Gansu, 730000

    Li Lin, Doctor, 13519665507, gs_linli@163.com

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

    Lingling Yu, Doctor, 13893110667, Yll8942344@163.com

  • Luoyang Central Hospital

    Luoyang, Henan, 471000

    Shuli Guo, Master, 13698827020, 13698827020@163.com

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

    Xiaoming Li, Master, 13700986866, Lxm6358@21cn.com

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

    Qingming Wang, Doctor, 13407911812, Wqming163@163.com

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi, 330038

    Hongbo Cheng, Doctor, 13707085405, 784260212@qq.com

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210009

    Zheng Ge, Doctor, 13915993701, gezheng2008@163.com

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

    Xiaoyan Qu, Doctor, 13770720898, quxiaoyan205@126.com

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Lin Luo, Doctor, 13597007307, 554359122@qq.com

  • The First Affiliated Hospital of Ningbo Universty

    Ningbo, Zhejiang, 315000

    Kaihong Xu, Doctor, 13605887040, xukaho@163.com

  • Ningbo No.2 Hospitai

    Ningbo, Zhejiang, 315016

    Suying Qian, Master, 18069075307, qiansuyinghao@163.com

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266011

    Yuping Zhong, Doctor, 17669757939, zhongyp3352@126.com

  • ZhongShan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

    Peng Liu, Doctor, 18286006744, liu.peng@zs-hospital.sh.cn

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

    Xiaoling Guo, Doctor, 13764643870, changchunkang7010@aliyun.com

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Aijun Liao, Doctor, 18940259833, liaoaijun@sina.com

  • The Second Hospital of Hebeimedical University

    Shijiazhuang, Hebei, 050000

    Lin Yang, Doctor, 18631116656, ylhbsjz@163.com

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 30000

    Liping Su, Doctor, 13835158122, slpsy2022@163.com

  • Tianjin Union Medical Center

    Tianjin, Tianjin Municipality, 300121

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 830000

    Yan Li, Master, 13639935315, liyan232917@139.com

  • The Second Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

    Fangxia Wang, Doctor, 13324551809, wfx197478@163.com

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi, 710048

    Pengcheng He, Doctor, 18991232609, Hepc_gcp@163.com

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221004

    Huanxin Zhang, Master, 15162171726, Huanxinzhang0212@163.com

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524023

    Honghua He, Master, 13828229695, 192880@qq.com

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Baijun Fang, Doctor, 13826607830, fdation@126.com

  • Henan Provincial People'S Hospital

    Zhengzhou, Henan, 450000

    Zunmin Zhu, Master, 13603712008, zhuzm1964@163.com

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou, Henan, 451191

    Chong Wang, Doctor, 13526681242, fccwangc@zzu.edu.cn

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007

    Chanjuan Shen, Master, 13707333899, Shenchuanjuan@163.com

Other trials in China

About this study

Official title: 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

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).

Being tested
TQB2934 injection, Pomalidomide Capsule, Selinexor tablets, Dexamethasone tablets
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB2934 injectionDrug

    TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).

  • Pomalidomide CapsuleDrug

    Pomalidomide capsules are an immunomodulatory(IMiD).

  • Selinexor tabletsDrug

    Selinexor is a selective nuclear export protein inhibitor.

  • Dexamethasone tabletsDrug

    Dexamethasone tablets are a type of adrenocortical hormone drug.

Study groups in NCT07569757
Study groupRoleWhat they receive
TQB2934 injectionExperimentalTQB2934 injection, 28 days as a treatment cycle.
Receives: Drug: TQB2934 injection
Selinexor and Dexamethasone or Pomalidomide DexamethasoneActive comparatorSelinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Receives: Drug: Pomalidomide Capsule; Drug: Selinexor tablets; Drug: Dexamethasone tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS)

    The time from randomization to disease progression or death from any cause, whichever occurs first.

    Measured: Baseline up to 5 years

Secondary outcomes (13)

  1. Investigator-assessed PFS

    The time from randomization to disease progression or death from any cause, whichever comes first.

    Measured: Baseline up to 5 years

  2. 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.

    Measured: From baseline to 18 months

  3. Overall response rate (ORR)

    The proportion of patients with a complete response (CR) or partial response (PR) after treatment.

    Measured: Baseline up to 5 years

  4. 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).

    Measured: Baseline up to 5 years

  5. Complete Response (CR) Rate

    The percentage of evaluable subjects who achieve complete response (CR).

    Measured: Baseline up to 5 years

  6. 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.

    Measured: Baseline up to 5 years

  7. Time to first remission (TTR)

    The time from randomization to the first achievement of objective response.

    Measured: Baseline up to 5 years

  8. Negative rate of minimal residual disease (MRD)

    The proportion of subjects achieving MRD negativity.

    Measured: Baseline up to 5 years

  9. Overall survival (OS)

    Time from randomization to death.

    Measured: From randomization to death, the estimated evaluation period is up to 5 years

  10. Adverse event rate

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

    Measured: From randomization to 2 months after the last dose

  11. Peak concentration (Cmax)

    Maximum plasma drug concentration.

    Measured: 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.

  12. Anti-drug antibody (ADA) positive rate

    The proportion of evaluable subjects with positive test results for anti-drug antibody (ADA).

    Measured: 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.

  13. Nab positive rate

    The percentage of evaluable subjects with positive neutralizing antibody (NAB) test results in all evaluable subjects.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07569757
Sponsor's protocol ID
TQB2934-III-01
Status last verified
Feb 2026
First submitted
29 Apr 2026
Last updated
8 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2934 injection, Pomalidomide Capsule and Selinexor tablets in people with Multiple Myeloma, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 49 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peng Liu, Doctor (18286006744, liu.peng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Baseline up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07569757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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