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Et studie til sammenligning af PK-karakteristika, sikkerhed, tolerabilitet og immunogenitet af HLX15-SC med DARZALEX FASPRO® i kombination med lenalidomid og dexamethason (Rd) hos transplanteringsuellige patienter med nyopdaget myelomatose

21. september 2026 opdateret af: Shanghai Henlius Biotech

En randomiseret, dobbeltblind, parallelkontrolleret fase I-studie til sammenligning af farmakokinetiske egenskaber, sikkerhed, tolerabilitet og immunogenitet af HLX15-SC med DARZALEX FASPRO® i kombination med lenalidomid og dexamethason (Rd) hos transplantationsuellige patienter med nydiagnosticeret multipelt myelom

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).

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
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Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: HLX15-SC-Rd

HLX15-SC-Rd
Medicin: 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).
Aktiv komparator: US-DARZALEX FASPRO®-Rd

US-DARZALEX FASPRO®-Rd
Medicin: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
pharmacokinetic (PK) similarity
Tidsramme: 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
Tidsramme: 7 days

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

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

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
PK characteristics
Tidsramme: 16 weeks

trough concentration (Ctrough)
16 weeks
PK characteristics
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 16 weeks

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

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

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

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

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

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Shanghai Henlius Biotech

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
25. maj 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
25. maj 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
22. februar 2028

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
27. februar 2026

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
12. marts 2026

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
17. marts 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
24. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
21. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • HLX15-SC-NDMM-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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