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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

7 mai 2026 mis à jour par: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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).

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

260

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • Chine
    • Anhui
      • Bengbu, Anhui, Chine, 233004
        • The First Affiliated Hospital of Bengbu Medical University
        • Contact:
          • Jiajia Li, Doctor
          • Numéro de téléphone: 13955207283
          • E-mail: 4119469@qq.com
      • Hefei, Anhui, Chine, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chine, 100020
        • Beijing Chao-Yang Hospital,Capital Medical University
      • Beijing, Beijing Municipality, Chine, 100020
        • Beijing Jishuitan Hospital,Capital Medical University
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Chine, 400010
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Chongqing, Chongqing Municipality, Chine, 400038
        • The Southwest Hospital of Amu
        • Contact:
    • Gansu
      • Lanzhou, Gansu, Chine, 730030
        • Lanzhou University Second Hospital
        • Contact:
      • Lanzhou, Gansu, Chine, 730000
        • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510280
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
      • Guangzhou, Guangdong, Chine, 510000
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contact:
      • Guangzhou, Guangdong, Chine, 510062
        • Sun Yat-sen University Cancer Center
        • Contact:
      • Zhanjiang, Guangdong, Chine, 524023
        • Affiliated Hospital of Guangdong Medical University
        • Contact:
          • Honghua He, Master
          • Numéro de téléphone: 13828229695
          • E-mail: 192880@qq.com
    • Guangxi
      • Nanning, Guangxi, Chine, 530000
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, Chine, 550001
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
          • Jie Xiong, Doctor
          • Numéro de téléphone: 18786687021
          • E-mail: 929438808@qq.com
    • Hebei
      • Cangzhou, Hebei, Chine, 061000
        • Cangzhou People's Hospital
        • Contact:
          • Hongmei Ma, Bachelor
          • Numéro de téléphone: 18031798229
          • E-mail: mhm-sspc@163.com
      • Chengde, Hebei, Chine, 067000
        • Affiliated Hospital of Chengde Medical University
        • Contact:
      • Shijiazhuang, Hebei, Chine, 050000
        • The Second Hospital of Hebeimedical University
        • Contact:
          • Lin Yang, Doctor
          • Numéro de téléphone: 18631116656
          • E-mail: ylhbsjz@163.com
    • Heilongjiang
      • Harbin, Heilongjiang, Chine, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
          • Wei Wang, Doctor
          • Numéro de téléphone: 13604880743
          • E-mail: ww0453@163.com
    • Henan
      • Luoyang, Henan, Chine, 471000
        • Luoyang Central Hospital
        • Contact:
      • Zhengzhou, Henan, Chine, 450000
        • Henan Cancer Hospital
        • Contact:
          • Baijun Fang, Doctor
          • Numéro de téléphone: 13826607830
          • E-mail: fdation@126.com
      • Zhengzhou, Henan, Chine, 450000
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, Chine, 451191
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hunan
      • Changsha, Hunan, Chine, 410013
        • The Third XIANGYA Hospital of Central South University
        • Contact:
      • Zhuzhou, Hunan, Chine, 412007
        • Zhuzhou Central Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, Chine, 210029
        • Jiangsu Province Hospital
        • Contact:
      • Nanjing, Jiangsu, Chine, 210009
        • Zhongda Hospital Southeast University
        • Contact:
      • Xuzhou, Jiangsu, Chine, 221004
        • The Affiliated Hospital of Xuzhou Medical University
        • Contact:
    • Jiangxi
      • Nanchang, Jiangxi, Chine, 330006
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Qingming Wang, Doctor
          • Numéro de téléphone: 13407911812
          • E-mail: Wqming163@163.com
      • Nanchang, Jiangxi, Chine, 330038
        • Jiangxi Provincial People's Hospital
        • Contact:
          • Hongbo Cheng, Doctor
          • Numéro de téléphone: 13707085405
          • E-mail: 784260212@qq.com
    • Liaoning
      • Shenyang, Liaoning, Chine, 110000
        • Shengjing Hospital of China Medical University
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, Chine, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, Chine, 710048
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contact:
          • Pengcheng He, Doctor
          • Numéro de téléphone: 18991232609
          • E-mail: Hepc_gcp@163.com
    • Shandong
      • Binzhou, Shandong, Chine, 256600
        • Binzhou Medical University Hospital
        • Contact:
      • Jinan, Shandong, Chine, 250117
        • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
        • Contact:
      • Jinan, Shandong, Chine, 250021
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）
        • Contact:
          • Xiangxiang Zhou, Doctor
          • Numéro de téléphone: 15866695595
          • E-mail: Zhouxx90@126.com
      • Jining, Shandong, Chine, 272111
        • Jining No.1 People's Hospital
        • Contact:
          • Haiguo Zhang, Master
          • Numéro de téléphone: 13666374406
          • E-mail: 149184728@qq.com
      • Qingdao, Shandong, Chine, 266011
        • Qingdao Municipal Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chine, 200032
        • Zhongshan Hospital Fudan University
        • Contact:
      • Shanghai, Shanghai Municipality, Chine, 200233
    • Shanxi
      • Changzhi, Shanxi, Chine, 46000
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contact:
      • Taiyuan, Shanxi, Chine, 30000
        • Shanxi Provincial Cancer Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, Chine, 610072
        • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
        • Contact:
          • Xiaobing Huang, Doctor
          • Numéro de téléphone: 18981838236
          • E-mail: hxb_trial@163.com
      • Luzhou, Sichuan, Chine, 646000
        • The Affiliated Hospital of Southwest Medical University
        • Contact:
          • Xiaoming Li, Master
          • Numéro de téléphone: 13700986866
          • E-mail: Lxm6358@21cn.com
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Chine, 300121
        • Tianjin Union Medical Center
    • Xinjiang
      • Ürümqi, Xinjiang, Chine, 830000
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
    • Yunnan
      • Kunming, Yunnan, Chine, 650000
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, Chine, 310000
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Ningbo, Zhejiang, Chine, 315000
        • The First Affiliated Hospital of Ningbo Universty
        • Contact:
          • Kaihong Xu, Doctor
          • Numéro de téléphone: 13605887040
          • E-mail: xukaho@163.com
      • Ningbo, Zhejiang, Chine, 315016
        • Ningbo No.2 Hospitai
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Inclusion Criteria:

  • 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.

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:

    1. 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)
  • Significant cardiovascular disease.
  • Neurological or psychiatric disorders.

  • Pulmonary diseases, including any of the following:

    1. 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.);
    2. 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
Médicament: TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Comparateur actif: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Médicament: Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
Médicament: Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
Médicament: Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free survival (PFS)
Délai: Baseline up to 5 years
The time from randomization to disease progression or death from any cause, whichever occurs first.
Baseline up to 5 years

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Investigator-assessed PFS
Délai: Baseline up to 5 years
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
Délai: From baseline to 18 months
The proportion of patients who remain free from disease progression or death at 6, 12 and 18 months after randomization.
From baseline to 18 months
Overall response rate (ORR)
Délai: Baseline up to 5 years
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)
Délai: Baseline up to 5 years
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
Délai: Baseline up to 5 years
The percentage of evaluable subjects who achieve complete response (CR).
Baseline up to 5 years
Duration of remission (DOR)
Délai: Baseline up to 5 years
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)
Délai: Baseline up to 5 years
The time from randomization to the first achievement of objective response.
Baseline up to 5 years
Negative rate of minimal residual disease (MRD)
Délai: Baseline up to 5 years
The proportion of subjects achieving MRD negativity.
Baseline up to 5 years
Overall survival (OS)
Délai: From randomization to death, the estimated evaluation period is up to 5 years
Time from randomization to death.
From randomization to death, the estimated evaluation period is up to 5 years
Adverse event rate
Délai: From randomization to 2 months after the last dose
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)
Délai: 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.
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
Délai: 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 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
Délai: 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 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 décembre 2028

Achèvement de l'étude (Estimé)

1 décembre 2030

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

29 avril 2026

Première publication (Réel)

6 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

8 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mai 2026

Dernière vérification

1 février 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • TQB2934-III-01

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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