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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

2026年5月7日 更新者：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).

調査の概要

状態

まだ募集していません

条件

介入・治療

研究の種類

介入

入学 (推定)

260

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
薬：TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
アクティブコンパレータ：Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
薬：Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
薬：Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
薬：Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Progression-free survival (PFS)
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Investigator-assessed PFS
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：Baseline up to 5 years
The percentage of evaluable subjects who achieve complete response (CR).
Baseline up to 5 years
Duration of remission (DOR)
時間枠：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)
時間枠：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)
時間枠：Baseline up to 5 years
The proportion of subjects achieving MRD negativity.
Baseline up to 5 years
Overall survival (OS)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年6月1日

一次修了 (推定)

2028年12月1日

研究の完了 (推定)

2030年12月1日

試験登録日

最初に提出

2026年4月29日

QC基準を満たした最初の提出物

2026年4月29日

最初の投稿 (実際)

2026年5月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月8日

QC基準を満たした最後の更新が送信されました

2026年5月7日

最終確認日

2026年2月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • TQB2934-III-01

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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