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Clinical Study of TQB2934 Injection in Relapsed/Refractory Multiple Myeloma

7. mai 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

260

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: TQB2934 injection
TQB2934 injection, 28 days as a treatment cycle.
Legemiddel: TQB2934 injection
TQB2934 injection is a bispecific antibody targeting B-cell maturation antigen (BCMA) and Cluster of Differentiation 3 (CD3).
Aktiv komparator: Selinexor and Dexamethasone or Pomalidomide Dexamethasone
Selinexor and Dexamethasone, 28 days as a treatment cycle or Pomalidomide Dexamethasone, 28 days as a treatment cycle
Legemiddel: Pomalidomide Capsule
Pomalidomide capsules are an immunomodulatory(IMiD).
Legemiddel: Selinexor tablets
Selinexor is a selective nuclear export protein inhibitor.
Legemiddel: Dexamethasone tablets
Dexamethasone tablets are a type of adrenocortical hormone drug.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Progression-free survival (PFS)
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

1. desember 2030

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

6. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. mai 2026

Sist bekreftet

1. februar 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TQB2934-III-01

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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