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Un estudio para comparar las características farmacocinéticas, seguridad, tolerabilidad e inmunogenicidad de HLX15-SC con DARZALEX FASPRO® en combinación con lenalidomida y dexametasona (Rd) en pacientes no elegibles para trasplante con mieloma múltiple recién diagnosticado

21 de septiembre de 2026 actualizado por: Shanghai Henlius Biotech

Un estudio aleatorizado, doble ciego, de control paralelo en fase I para comparar las características farmacocinéticas, la seguridad, la tolerabilidad y la inmunogenicidad de HLX15-SC con DARZALEX FASPRO® en combinación con lenalidomida y dexametasona (Rd) en pacientes con mieloma múltiple de reciente diagnóstico no elegibles para trasplante

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).

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

258

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HLX15-SC-Rd

HLX15-SC-Rd
Droga: 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).
Comparador activo: US-DARZALEX FASPRO®-Rd

US-DARZALEX FASPRO®-Rd
Droga: 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).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
pharmacokinetic (PK) similarity
Periodo de tiempo: 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
Periodo de tiempo: 7 days

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

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
PK characteristics
Periodo de tiempo: 16 weeks

trough concentration (Ctrough)
16 weeks
PK characteristics
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 16 weeks

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

including body temperature (°C) measured by clinical thermometer
16 weeks
Safety: Physical examinations
Periodo de tiempo: 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
Periodo de tiempo: 16 weeks

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

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

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

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Shanghai Henlius Biotech

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de mayo de 2026

Finalización primaria (Estimado)

25 de mayo de 2027

Finalización del estudio (Estimado)

22 de febrero de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de febrero de 2026

Primero enviado que cumplió con los criterios de control de calidad

12 de marzo de 2026

Publicado por primera vez (Actual)

17 de marzo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

21 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HLX15-SC-NDMM-001

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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