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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

7. května 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

260

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
Lék: TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Aktivní komparátor: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Lék: Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
Lék: Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
Lék: Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Progression-free survival (PFS)
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Investigator-assessed PFS
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: Baseline up to 5 years
The percentage of evaluable subjects who achieve complete response (CR).
Baseline up to 5 years
Duration of remission (DOR)
Časové okno: 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)
Časové okno: 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)
Časové okno: Baseline up to 5 years
The proportion of subjects achieving MRD negativity.
Baseline up to 5 years
Overall survival (OS)
Časové okno: 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
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. prosince 2028

Dokončení studie (Odhadovaný)

1. prosince 2030

Termíny zápisu do studia

První předloženo

29. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

29. dubna 2026

První zveřejněno (Aktuální)

6. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. května 2026

Naposledy ověřeno

1. února 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TQB2934-III-01

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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