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Исследование по сравнению фармакокинетических характеристик, безопасности, переносимости и иммуногенности препарата HLX15-SC с DARZALEX FASPRO® в комбинации с леналидомидом и дексаметазоном (Rd) у пациентов с впервые диагностированной множественной миеломой, не подлежащих трансплантации

21 сентября 2026 г. обновлено: Shanghai Henlius Biotech

Рандомизированное двойное слепое исследование фазы I с параллельными группами для сравнения фармакокинетических характеристик, безопасности, переносимости и иммуногенности препарата HLX15-SC с DARZALEX FASPRO® в комбинации с леналидомидом и дексаметазоном (Rd) у пациентов с впервые диагностированной множественной миеломой, не подходящих для трансплантации

The purpose of this study is to compare the pharmacokinetic (PK) similarity, safety, tolerability, immunogenicity, and efficacy of HLX15-SC versus US-DARZALEX FASPRO® following single and multiple subcutaneous (SC) injections in newly diagnosed MM patients ineligible for transplant.

Participants who meet all inclusion criteria and none of the exclusion criteria will receive either the HLX15-SC-Rd regimen or the D-Rd regimen for 4 cycles (one cycle = 4 weeks). After 4 cycles of treatment, based on clinical benefit and participant preference, participants may continue to receive the locally marketed daratumumab subcutaneous formulation (Dara-SC) in combination with Rd according to clinical practice, up to 32 weeks or until loss of clinical benefit, death, unacceptable toxicity, withdrawal of informed consent, or any other protocol-specified reason, whichever occurs first. After 32 weeks of dosing, participants will continue to receive appropriate standard of care according to local guidelines (including marketed Dara-SC).

Обзор исследования

Статус

Рекрутинг

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

258

Фаза

  • Фаза 1

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Yinping Zhong
  • Номер телефона: +86-13983654553
  • Электронная почта: Yinping_Zhong@henlius.com

Места учебы

  • Австралия
      • Perth, Австралия, 6005
        • Рекрутинг
        • Perth Blood Institute
  • Грузия
      • Tbilisi, Грузия, 0159
        • Еще не набирают
        • JSC K. Eristavi National Center of Experimental and Clinical Surgery
      • Tbilisi, Грузия, 0160
        • Еще не набирают
        • LLC Caucasus Medical Centre
  • Китай
    • Anhui
      • Bengbu, Anhui, Китай, 233000
        • Рекрутинг
        • The First Affiliated Hospital of Bengbu Medical University
      • Hefei, Anhui, Китай, 230601
        • Рекрутинг
        • The Second Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, Китай, 230031
        • Рекрутинг
        • Anhui Provincial Cancer Hospital
    • Beijing Municipality
      • Beijing, Beijing Municipality, Китай, 100191
        • Рекрутинг
        • Peking University Third Hospital
      • Beijing, Beijing Municipality, Китай, 100035
        • Рекрутинг
        • Peking University First Hospital
      • Beijing, Beijing Municipality, Китай, 100027
        • Рекрутинг
        • Beijing Chao-Yang Hospital Capital Medical University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Китай, 400016
        • Рекрутинг
        • The First Affiliated Hospital of Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, Китай, 350004
        • Рекрутинг
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, Китай, 361001
        • Рекрутинг
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, Китай, 510080
        • Рекрутинг
        • Guangdong General Hospital
      • Guangzhou, Guangdong, Китай, 510013
        • Рекрутинг
        • Guangzhou First People's Hospital
      • Guangzhou, Guangdong, Китай, 510220
        • Рекрутинг
        • Zhujiang Hospital of Southern Medical University
      • Meizhou, Guangdong, Китай, 514031
        • Рекрутинг
        • Meizhou People's Hospital
      • Shenzhen, Guangdong, Китай, 518020
        • Рекрутинг
        • Shenzhen People's Hospital
      • Shenzhen, Guangdong, Китай, 518036
        • Рекрутинг
        • Peking University Shenzhen Hospital
    • Guangxi
      • Liuzhou, Guangxi, Китай, 545007
        • Рекрутинг
        • Liuzhou Worker's Hospital
      • Nanning, Guangxi, Китай, 530213
        • Рекрутинг
        • Guangxi Medical University Cancer Hospital
    • Guizhou
      • Guiyang, Guizhou, Китай, 550004
        • Рекрутинг
        • The Affiliated Hospital of Guizhou Medical University
    • Hebei
      • Baoding, Hebei, Китай, 071030
        • Рекрутинг
        • Affiliated Hospital of Hebei University
      • Cangzhou, Hebei, Китай, 061000
        • Рекрутинг
        • Cangzhou People's Hospital
      • Shijiazhuang, Hebei, Китай, 050071
        • Рекрутинг
        • The Second Hospital of Hebei Medical Universit
      • Shijiazhuang, Hebei, Китай, 050052
        • Рекрутинг
        • Hebei medical university third hospital
    • Heilongjiang
      • Harbin, Heilongjiang, Китай, 150069
        • Рекрутинг
        • Harbin Medical University Cancer Hospital
    • Henan
      • Luoyang, Henan, Китай, 471003
        • Рекрутинг
        • The First Affiliated Hospital of Henan University of Science & Techinology
      • Xinxiang, Henan, Китай, 453000
        • Рекрутинг
        • Xinxiang Central Hospital
      • Zhengzhou, Henan, Китай, 450003
        • Рекрутинг
        • Henan Cancer Hospital
      • Zhengzhou, Henan, Китай, 450052
        • Рекрутинг
        • The First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, Китай, 450003
        • Рекрутинг
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, Китай, 430071
        • Рекрутинг
        • Zhongnan Hospital of Wuhan University
      • Wuhan, Hubei, Китай, 430061
        • Рекрутинг
        • Renmin Hospital of Wuhan University
      • Wuhan, Hubei, Китай, 430014
        • Рекрутинг
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, Китай, 430030
        • Рекрутинг
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
    • Hunan
      • Changsha, Hunan, Китай, 410011
        • Рекрутинг
        • The Second Xiangya Hospital of Central South University
      • Hengyang, Hunan, Китай, 421001
        • Рекрутинг
        • The First Affiliated Hospital Of University South China
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Китай, 010030
        • Рекрутинг
        • The Affiliated Hospital of Inner Mongolia Medical University
    • Jangxi
      • Nanchang, Jangxi, Китай, 330008
        • Рекрутинг
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jangxi, Китай, 330008
        • Рекрутинг
        • The second affiliated hospital of Nanchang University
    • Jiangsu
      • Nanjing, Jiangsu, Китай, 210009
        • Рекрутинг
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, Китай, 211166
        • Рекрутинг
        • Sir Run Run Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, Китай, 215004
        • Рекрутинг
        • Nuclear Industry General Hospital (The Second Affiliated Hospital of Soochow University)
      • Wuxi, Jiangsu, Китай, 214000
        • Рекрутинг
        • Affiliated Hospital of Jiangnan University
      • Xuzhou, Jiangsu, Китай, 221006
        • Рекрутинг
        • The Affiliated Hospital of Xuzhou Medical University
    • Jiangxi
      • Ganzhou, Jiangxi, Китай, 341000
        • Рекрутинг
        • First Affiliated Hospital of Gannan Medical University
      • Nanchang, Jiangxi, Китай, 330029
        • Рекрутинг
        • Jiangxi Cancer Hospital
    • Liaoning
      • Dalian, Liaoning, Китай, 116001
        • Рекрутинг
        • Affiliated Zhongshan Hospital of Dalian University
      • Shenyang, Liaoning, Китай, 110004
        • Рекрутинг
        • Shengjing Hospital of China Medical University
      • Shenyang, Liaoning, Китай, 110001
        • Рекрутинг
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, Китай, 110041
        • Рекрутинг
        • Liaoning Cancer Hospital & Institute
    • Shandong
      • Jinan, Shandong, Китай, 250022
        • Рекрутинг
        • Shandong Provincial Hospital
      • Jining, Shandong, Китай, 272000
        • Рекрутинг
        • Jining No.1 People's Hospital
      • Qingdao, Shandong, Китай, 266001
        • Рекрутинг
        • The Affiliated Hospital of Qingdao University
      • Weifang, Shandong, Китай, 261041
        • Рекрутинг
        • Weifang People's Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 200032
        • Рекрутинг
        • Zhongshan Hospital, Fudan University
    • Shanxi
      • Taiyuan, Shanxi, Китай, 030001
        • Рекрутинг
        • The Second Hospital of Shanxi Medical University
      • Taiyuan, Shanxi, Китай, 030013
        • Рекрутинг
        • Shanxi Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, Китай, 610041
        • Рекрутинг
        • Sichuan Cancer Hospital
      • Chengdu, Sichuan, Китай, 610073
        • Рекрутинг
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Китай, 300060
        • Рекрутинг
        • Tianjin Medical University Cancer Institute & Hospital
      • Tianjin, Tianjin Municipality, Китай, 300308
        • Рекрутинг
        • Tianjin Cancer Hospital Airport Hospital
      • Tianjin, Tianjin Municipality, Китай, 300131
        • Рекрутинг
        • Tianjin People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Китай, 310006
        • Рекрутинг
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, Китай, 310015
        • Рекрутинг
        • Zhejiang Provincial People's Hospital
      • Hangzhou, Zhejiang, Китай, 310016
        • Рекрутинг
        • Sir Run Run Shaw Hospital Zhejiang University School of Medicine（The Grand Canal Campus）
      • Hangzhou, Zhejiang, Китай, 310020
        • Рекрутинг
        • The First Affiliated Hospital, Zhejiang University School of Medicine
      • Ningbo, Zhejiang, Китай, 315010
        • Рекрутинг
        • The First Affiliated Hospital of Ningbo University
      • Wenzhou, Zhejiang, Китай, 325000
        • Рекрутинг
        • The Second Affiliated Hospital of Wenzhou Medical University
  • Сербия
      • Belgrade, Сербия, 11080
        • Еще не набирают
        • Clinical Hospital Centre Zemun
      • Kragujevac, Сербия, 34000
        • Еще не набирают
        • University Clinical Center Kragujevac
      • Niš, Сербия, 8000
        • Еще не набирают
        • University Clinical Center Nis
  • Соединенные Штаты
    • Arkansas
      • Springdale, Arkansas, Соединенные Штаты, 72762
        • Рекрутинг
        • Highlands Oncology Group, PA
    • Florida
      • Jacksonville, Florida, Соединенные Штаты, 32256
        • Рекрутинг
        • Cancer Specialists of North Florida
      • Margate, Florida, Соединенные Штаты, 33063
        • Рекрутинг
        • D&H National Research Center
      • Ocala, Florida, Соединенные Штаты, 34474
        • Рекрутинг
        • Ocala Oncology Center
      • Plantation, Florida, Соединенные Штаты, 33322
        • Рекрутинг
        • Florida Clinical Trials Group
      • Tamarac, Florida, Соединенные Штаты, 33321
        • Рекрутинг
        • Florida Clinical Trials Group
    • Indiana
      • Dyer, Indiana, Соединенные Штаты, 46311
        • Рекрутинг
        • Genesis Medical Research
    • Louisiana
      • Covington, Louisiana, Соединенные Штаты, 70433
        • Рекрутинг
        • Pontchartrain Cancer Center
    • Texas
      • Houston, Texas, Соединенные Штаты, 77030
        • Рекрутинг
        • Oncology Consultants (P1 Trials -Exigent Network)
      • Houston, Texas, Соединенные Штаты, 77090
        • Рекрутинг
        • Lumi Research
    • Washington
      • Everett, Washington, Соединенные Штаты, 98201
        • Рекрутинг
        • Optum Care Washington
      • Olympia, Washington, Соединенные Штаты, 98506
        • Рекрутинг
        • American Oncology Network Vista Oncology Division / Physician partner associate

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria:

  1. Age ≥ 18 years at the time of signing the informed consent form (ICF).

  2. Body mass index (BMI): 18.5 kg/m2 ≤ BMI < 28 kg/m2.

  3. Subjects must participate voluntarily, understand the study, and sign the ICF.

  4. Patients must have a documented diagnosis of multiple myeloma (MM) according to the International Myeloma Working Group (IMWG) criteria, with measurable lesion .

  5. Serum albumin ≥ 35 g/L.

  6. Newly diagnosed, untreated, and considered ineligible for high-dose chemotherapy with autologous stem cell transplantation (ASCT) by the investigator.

  7. The patient's ECOG performance status must be 0 or 1 .

  8. Patient must have clinical laboratory values meeting the following criteria during the screening period:

    1. Hemoglobin ≥ 7.5 g/dL (≥ 5 mmol/L; red blood cell [RBC] transfusion or use of recombinant human erythropoietin at least 1 week prior to randomization is allowed).
    2. Absolute neutrophil count (ANC) ≥ 1.0 × 109/L (use of granulocyte-colony stimulating factor [G-CSF] is allowed).
    3. Alanine aminotransferase (ALT) ≤ 2.5 × upper limit of normal (ULN).
    4. Without the following evidence of impaired liver function, including mild impairment (total bilirubin ≤ ULN and AST > ULN or ULN < total bilirubin ≤ 1.5 x ULN), moderate impairment (1.5 x ULN < total bilirubin ≤ 3 x ULN), and severe impairment (total bilirubin > 3 x ULN).
    5. Measured creatinine clearance ≥ 40 mL/min .
    6. Corrected serum calcium < 14 mg/dL (< 3.5 mmol/L); or free ionized calcium < 6.5 mg/dL (< 1.6 mmol/L) .
    7. Platelet count ≥ 70 × 109/L for patients with plasma cells < 50% of bone marrow nucleated cells; platelet count > 50 × 109/L for all other patients (transfusion within 3 days prior to randomization to achieve the minimum platelet count is not permitted).

  9. Contraceptive criteria: Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    1. Female patients: a female patient is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

      Not a woman of childbearing potential (WOCBP) or WOCBP: must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously from signed ICF to at least 140 days following the last dose of study products. This includes one highly effective contraceptive method with a failure rate of < 1% per year (tubal ligation, intrauterine device, hormonal [birth control pills, injections, hormonal patches, vaginal rings or implants] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.

      The subjects also need to agree not to donate or cryopreservation eggs (ova, oocytes) from signed ICF to at least 140 days following the last dose of study products.

    2. Male patients: male patients are eligible to participate if they agree to the following during the intervention period and for at least 140 days following the last dose of study products:

    Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent.

    or Agree to use a male condom and female partner to use an additional highly effective contraceptive method with a failure rate of <1% per year as when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.

    Agree not to donate or cryopreservation sperm.

  10. A WOCBP must have a negative serum pregnancy test at screening within 72 h prior to randomization. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy

Exclusion Criteria:

  1. Patient has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions.

  2. Patient has plasma cell leukemia (according to IMWG criterion: ≥ 5% of plasma cells in the peripheral blood and/or an absolute plasma cell count of ≥ 2 x 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).

  3. Patient has prior or current systemic therapy or ASCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before randomization.

  4. Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.

  5. Patient has a history of malignancy (other than MM) within 3 years before the date of randomization (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator is considered cured with minimal risk of recurrence within 3 years).

  6. Patient has clinical signs of meningeal involvement of MM.

  7. Patient has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume in 1 second [FEV1] < 50% of predicted normal), persistent asthma, or a history of asthma within the last 2 years. Patient with known or suspected COPD or asthma must have a FEV1 test during screening.

  8. Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).

  9. Patient is known to have active hepatitis B or C.

    1. Patient is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Patients with resolved infection (that is, patients who are HBsAg negative but positive for antibodies to hepatitis B core antigen [Anti-HBc] and/or antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded.

      EXCEPTION: Patients with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.

    2. Patient is seropositive for hepatitis C must be screened using PCR measurement of hepatitis C virus (HCV) ribonucleic acid (RNA) levels. Those who are PCR positive will be excluded.

  10. Patient has any concurrent medical or psychiatric condition or disease (e.g., active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.

  11. Patient has clinically significant cardiac disease, including:

    1. Myocardial infarction within 1 year before randomization, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association [NYHA] Class III-IV ).
    2. Cardiac arrhythmia (NCI-CTCAE Version 6 Grade ≥ 2) or clinically significant ECG abnormalities.
    3. Screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) (See Appendix 6) > 470 ms.

  12. Patient has known allergies, hypersensitivity, or intolerance to lenalidomide, corticosteroids, monoclonal antibodies or human proteins, or their excipients or known sensitivity to mammalian-derived products.

  13. Patient has history of drug abuse or substance abuse one year prior to randomization. Patient is known or suspected of not being able to comply with the study protocol (e.g., because of alcoholism, drug dependency, or psychological disorder).

  14. Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes) while enrolled in this study or within 140 days after the last dose of study products.

    Or patient is a man who plans to father a child and/or donate sperm while enrolled in this study or within 140 days after the last dose of study products.

    Patient does not agree to abstain completely from sexual intercourse, or plan to use a contraceptive method that is not acceptable to the investigator (unacceptable methods of contraception include: i. periodic abstinence [such as calendar method, ovulation method, basal body temperature method, post-ovulation safety period method, etc.], withdrawal, etc.; ii. medical contraceptive measures such as oral contraceptives, contraceptive injections, contraceptive patches, subcutaneous implantation, intrauterine hormone contraceptive devices, local contraceptives such as spermicides, etc.).

  15. Patient had radiation therapy within 14 days of randomization.

  16. Patient had plasmapheresis within 28 days of randomization.

  17. Patient had a history of blood donation or total blood loss of 200 mL or more within 3 months before randomization.

  18. Patient had major surgery within 28 days before randomization or has not fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 28 days after the last dose of study treatment. Kyphoplasty is not considered major surgery.

  19. Patient in clinical trials of any other drug or device within 3 months (or 5 half-lives of the corresponding investigational product if the half-life of the drug is long [5 half-lives > 3 months]) before randomization.

  20. Patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: HLX15-SC-Rd

HLX15-SC-Rd
Лекарство: HLX15-SC-Rd

Subjects will receive 1800 mg HLX15-SC via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).
Активный компаратор: US-DARZALEX FASPRO®-Rd

US-DARZALEX FASPRO®-Rd
Лекарство: US-DARZALEX FASPRO®-Rd

Subjects will receive 1800 mg US-DARZALEX FASPRO® via SC administration for up to 16 weeks: weekly during Week 1-8 (Cycle 1-2; 1 cycle = 4 weeks) and every two weeks during Week 9-16 (Cycle 3-4).

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
pharmacokinetic (PK) similarity
Временное ограничение: 7 days

Area under the serum concentration-time curve from time 0 to day 7 (AUC0-7d) after the 1st dose.
7 days
pharmacokinetic (PK) similarity
Временное ограничение: 7 days

The maximum (peak) serum drug concentration (Cmax) after the 1st dose.
7 days
pharmacokinetic (PK) similarity
Временное ограничение: 16 weeks

Area under the serum concentration-time curve within a dosing interval at steady-state (AUCss) after the 12th dose
16 weeks
pharmacokinetic (PK) similarity
Временное ограничение: 16 weeks

The maximum (peak) serum drug concentration at steady-state (Cmax,ss) after the 12th dose
16 weeks

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
PK characteristics
Временное ограничение: 16 weeks

trough concentration (Ctrough)
16 weeks
PK characteristics
Временное ограничение: 16 weeks

trough concentration at steady state (Ctrough,ss).
16 weeks
Safety: Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)
Временное ограничение: 16 weeks

Adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) terms and frequency of occurrence judged by investigators
16 weeks
Safety: Vital Signs
Временное ограничение: 16 weeks

Vital Signs: including blood pressure (systolic and diastolic; mmHg) , pulse rate (beats/min) measured by hematomanometer
16 weeks
Safety: Vital Signs
Временное ограничение: 16 weeks

including body temperature (°C) measured by clinical thermometer
16 weeks
Safety: Physical examinations
Временное ограничение: 16 weeks

Physical examinations: includes general condition; head and neck; mucous membranes; chest; abdomen; spine; extremities; musculoskeletal system; neurological system; lymphatic system; and skin checked by investigators
16 weeks
Safety: Laboratory tests
Временное ограничение: 16 weeks

Laboratory tests: include hematology, blood chemistry, and urinalysis measured by the department of medical laboratory in site
16 weeks
Safety: Electrocardiography
Временное ограничение: 16 weeks

Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes heart rate（beats per minute ）
16 weeks
Safety: Electrocardiography
Временное ограничение: 16 weeks

Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes PR interval（msec）.
16 weeks
Safety: Electrocardiography
Временное ограничение: 16 weeks

Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes QRS duration (msec).
16 weeks
Safety: Electrocardiography
Временное ограничение: 16 weeks

Electrocardiography: 12-lead ECG will be performed by qualified personnel using an ECG machine, includes QTc interval (msec).
16 weeks
Immunogenicity:
Временное ограничение: 16 weeks

Incidence of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) against the study products (HLX15-SC and US-DARZALEX FASPRO®) and hyaluronidase.
16 weeks
Efficacy:ORR
Временное ограничение: 16 weeks

Investigator-assessed overall response rate (ORR): is defined as the percentage of all patients achieving a PR or better after the randomization date.
16 weeks
Efficacy: partial response (PR) rate
Временное ограничение: 16 weeks

Partial response (PR) rate is defined as the percentage of all patients achieving a PR at any time point after the randomization date
16 weeks
Efficacy: very good partial response (VGPR) rate
Временное ограничение: 16 weeks

Very good partial response (VGPR) rate is defined as the percentage of all patients achieving a VGPR at any time point after the randomization date.
16 weeks
Efficacy: complete response (CR) rate
Временное ограничение: 16 weeks

Complete response (CR) rate is defined as the percentage of all patients achieving a CR at any time point after the randomization date.
16 weeks
Efficacy: stringent complete response (sCR) rate
Временное ограничение: 16 weeks

Stringent complete response (sCR) rate is defined as the percentage of all patients achieving an sCR at any time point after the randomization date.
16 weeks
Efficacy: time to response
Временное ограничение: 16 weeks

Time to Response (TTR) is defined as the time from randomization to the first documented response of PR or better. TTR will be analyzed only for patients who achieve a response of PR or better.
16 weeks

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Shanghai Henlius Biotech

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

25 мая 2026 г.

Первичное завершение (Оцененный)

25 мая 2027 г.

Завершение исследования (Оцененный)

22 февраля 2028 г.

Даты регистрации исследования

Первый отправленный

27 февраля 2026 г.

Впервые представлено, что соответствует критериям контроля качества

12 марта 2026 г.

Первый опубликованный (Действительный)

17 марта 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

24 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

21 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • HLX15-SC-NDMM-001

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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