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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

7 maggio 2026 aggiornato da: 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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

260

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Anhui
      • Bengbu, Anhui, Cina, 233004
        • The First Affiliated Hospital of Bengbu Medical University
        • Contatto:
          • Jiajia Li, Doctor
          • Numero di telefono: 13955207283
          • Email: 4119469@qq.com
      • Hefei, Anhui, Cina, 230022
        • The First Affiliated Hospital of Anhui Medical University
        • Contatto:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100020
        • Beijing Chao-Yang Hospital,Capital Medical University
      • Beijing, Beijing Municipality, Cina, 100020
        • Beijing Jishuitan Hospital,Capital Medical University
        • Contatto:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Cina, 400010
        • The First Affiliated Hospital of Chongqing Medical University
        • Contatto:
      • Chongqing, Chongqing Municipality, Cina, 400038
        • The Southwest Hospital of Amu
        • Contatto:
    • Gansu
      • Lanzhou, Gansu, Cina, 730030
        • Lanzhou University Second Hospital
        • Contatto:
      • Lanzhou, Gansu, Cina, 730000
        • Gansu Provincial Maternal and Child Health Hospital (Gansu Provincial Central Hospital)
        • Contatto:
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510280
        • Zhujiang Hospital of Southern Medical University
        • Contatto:
      • Guangzhou, Guangdong, Cina, 510000
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contatto:
      • Guangzhou, Guangdong, Cina, 510062
        • Sun Yat-sen University Cancer Center
        • Contatto:
      • Zhanjiang, Guangdong, Cina, 524023
        • Affiliated Hospital of Guangdong Medical University
        • Contatto:
          • Honghua He, Master
          • Numero di telefono: 13828229695
          • Email: 192880@qq.com
    • Guangxi
      • Nanning, Guangxi, Cina, 530000
        • The First Affiliated Hospital of Guangxi Medical University
        • Contatto:
    • Guizhou
      • Guiyang, Guizhou, Cina, 550001
        • The Affiliated Hospital of Guizhou Medical University
        • Contatto:
    • Hebei
      • Cangzhou, Hebei, Cina, 061000
        • Cangzhou People's Hospital
        • Contatto:
      • Chengde, Hebei, Cina, 067000
        • Affiliated Hospital of Chengde Medical University
        • Contatto:
      • Shijiazhuang, Hebei, Cina, 050000
        • The Second Hospital of Hebeimedical University
        • Contatto:
    • Heilongjiang
      • Harbin, Heilongjiang, Cina, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Contatto:
          • Wei Wang, Doctor
          • Numero di telefono: 13604880743
          • Email: ww0453@163.com
    • Henan
      • Luoyang, Henan, Cina, 471000
        • Luoyang Central Hospital
        • Contatto:
      • Zhengzhou, Henan, Cina, 450000
        • Henan Cancer Hospital
        • Contatto:
          • Baijun Fang, Doctor
          • Numero di telefono: 13826607830
          • Email: fdation@126.com
      • Zhengzhou, Henan, Cina, 450000
        • Henan Provincial People's Hospital
        • Contatto:
      • Zhengzhou, Henan, Cina, 451191
        • The First Affiliated Hospital of Zhengzhou University
        • Contatto:
    • Hunan
      • Changsha, Hunan, Cina, 410013
        • The Third Xiangya Hospital of Central South University
        • Contatto:
      • Zhuzhou, Hunan, Cina, 412007
        • ZhuZhou Central Hospital
        • Contatto:
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210029
        • Jiangsu Province Hospital
        • Contatto:
      • Nanjing, Jiangsu, Cina, 210009
        • Zhongda Hospital Southeast University
        • Contatto:
      • Xuzhou, Jiangsu, Cina, 221004
        • The Affiliated Hospital of Xuzhou Medical University
        • Contatto:
    • Jiangxi
      • Nanchang, Jiangxi, Cina, 330006
        • The Second Affiliated Hospital of Nanchang University
        • Contatto:
      • Nanchang, Jiangxi, Cina, 330038
        • Jiangxi Provincial People's Hospital
        • Contatto:
    • Liaoning
      • Shenyang, Liaoning, Cina, 110000
        • Shengjing Hospital of China Medical University
        • Contatto:
    • Shaanxi
      • Xi'an, Shaanxi, Cina, 710004
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contatto:
      • Xi'an, Shaanxi, Cina, 710048
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Contatto:
    • Shandong
      • Binzhou, Shandong, Cina, 256600
        • Binzhou Medical University Hospital
        • Contatto:
      • Jinan, Shandong, Cina, 250117
        • Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
        • Contatto:
      • Jinan, Shandong, Cina, 250021
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）
        • Contatto:
          • Xiangxiang Zhou, Doctor
          • Numero di telefono: 15866695595
          • Email: Zhouxx90@126.com
      • Jining, Shandong, Cina, 272111
        • Jining No.1 People's Hospital
        • Contatto:
      • Qingdao, Shandong, Cina, 266011
        • Qingdao Municipal Hospital
        • Contatto:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200032
        • Zhongshan Hospital Fudan University
        • Contatto:
      • Shanghai, Shanghai Municipality, Cina, 200233
    • Shanxi
      • Changzhi, Shanxi, Cina, 46000
        • Heping Hospital Affiliated to Changzhi Medical College
        • Contatto:
      • Taiyuan, Shanxi, Cina, 30000
        • Shanxi Provincial Cancer Hospital
        • Contatto:
    • Sichuan
      • Chengdu, Sichuan, Cina, 610072
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
        • Contatto:
      • Luzhou, Sichuan, Cina, 646000
        • The Affiliated Hospital of Southwest Medical University
        • Contatto:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Cina, 300121
        • Tianjin Union Medical Center
    • Xinjiang
      • Ürümqi, Xinjiang, Cina, 830000
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contatto:
    • Yunnan
      • Kunming, Yunnan, Cina, 650000
        • The First Affiliated Hospital of Kunming Medical University
        • Contatto:
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310000
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Ningbo, Zhejiang, Cina, 315000
        • The First Affiliated Hospital of Ningbo Universty
        • Contatto:
          • Kaihong Xu, Doctor
          • Numero di telefono: 13605887040
          • Email: xukaho@163.com
      • Ningbo, Zhejiang, Cina, 315016
        • Ningbo No.2 Hospitai
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
Droga: TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Comparatore attivo: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Droga: Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
Droga: Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
Droga: Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-free survival (PFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Investigator-assessed PFS
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: Baseline up to 5 years
The percentage of evaluable subjects who achieve complete response (CR).
Baseline up to 5 years
Duration of remission (DOR)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Baseline up to 5 years
The proportion of subjects achieving MRD negativity.
Baseline up to 5 years
Overall survival (OS)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 dicembre 2030

Date di iscrizione allo studio

Primo inviato

29 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 aprile 2026

Primo Inserito (Effettivo)

6 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 febbraio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • TQB2934-III-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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CROs in Hong Kong

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

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