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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

2026년 5월 7일 업데이트: 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).

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

260

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
의약품: TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
활성 비교기: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
의약품: Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
의약품: Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
의약품: Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Progression-free survival (PFS)
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Investigator-assessed PFS
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: Baseline up to 5 years
The percentage of evaluable subjects who achieve complete response (CR).
Baseline up to 5 years
Duration of remission (DOR)
기간: 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)
기간: 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)
기간: Baseline up to 5 years
The proportion of subjects achieving MRD negativity.
Baseline up to 5 years
Overall survival (OS)
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2028년 12월 1일

연구 완료 (추정된)

2030년 12월 1일

연구 등록 날짜

최초 제출

2026년 4월 29일

QC 기준을 충족하는 최초 제출

2026년 4월 29일

처음 게시됨 (실제)

2026년 5월 6일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 7일

마지막으로 확인됨

2026년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TQB2934-III-01

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

다발성 골수종에 대한 임상 시험

TQB2934 injection에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in France

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다