A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma

Официальное название

A Randomized, Double-blind, Parallel-controlled, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma

Обзор

This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).

Вмешательства

• Препарат HLX15-IV
  recombinant anti-CD38 human monoclonal antibody injection
• Препарат Darzalex
  recombinant anti-CD38 human monoclonal antibody injection

Первичные конечные точки

• IRC-assessed Week 24 rate of very good partial response (VGPR) or better [Срок оценки: 24 weeks]

Вторичные конечные точки (12)

• Investigator-assessed Week 24 rate of VGPR or better [Срок оценки: 24 weeks]
• IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better [Срок оценки: 12,36,48 weeks]
• IRC- and investigator-assessed partial response (PR) rate [Срок оценки: 48 weeks]
• IRC- and investigator-assessed complete response (CR) rate [Срок оценки: 48 weeks]
• IRC- and investigator-assessed stringent complete response (sCR) rate [Срок оценки: 48 weeks]
• IRC- and investigator-assessed complete response (CR) or better rate [Срок оценки: 48 weeks]
• IRC- and investigator-assessed overall response rate [Срок оценки: 48 weeks]
• IRC- and investigator-assessed time to response (TTR) [Срок оценки: 48 weeks]
• IRC- and investigator-assessed duration of response (DOR) [Срок оценки: 48 weeks]
• IRC- and investigator-assessed progression free survival (PFS) [Срок оценки: 48 weeks]
• Minimal residual disease (MRD) negative rate [Срок оценки: 48 weeks]
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30). [Срок оценки: 48 weeks]

Критерии участия

Критерии включения

• Capable to understand and sign the ICF.
• Patients aged ≥ 18 years .
• Patient must have documented multiple myeloma (MM) satisfying the International Myeloma Working Group (IMWG) diagnostic criteria for MM.
• Newly diagnosed, untreated and not considered candidate for autologous stem cell transplantation (ASCT).
• Patient must have an ECOG performance status score of 0.
• Patient must have pretreatment clinical laboratory values.
• Contraceptive use by men or women should be consistent with local regulations.
• A WOCBP must have a negative serum pregnancy test at screening within 72 hours prior to randomization.

Критерии исключения

• 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.
• Patient has plasma cell leukemia or POEMS syndrome .
• Patient has prior or current systemic therapy or ASCT for MM before randomization.
• Patient has peripheral neuropathy or neuropathic pain Grade 2 or higher.
• Patient has a history of malignancy (other than MM) within 3 years before randomization .
• Patient has clinical signs of meningeal involvement of MM.
• Patient has known COPD, persistent asthma, or a history of asthma within the last 2 years.
• Patient is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have treponema pallidum antibodies (Anti-TP).
• Patient is known to have active hepatitis B or C.
• Patient has any concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results.
• Patient has clinically significant cardiac disease.
• Patient has known allergies, hypersensitivity, or intolerance to treatment drugs.
• Patient has history of drug abuse or substance abuse.
• Patient is a woman who is pregnant, or breast-feeding, or planning to become pregnant or donate eggs (ova, oocytes).
• Patient had radiation therapy within 14 days of randomization.
• Patient had plasmapheresis within 28 days of randomization.
• Patient had major surgery within 28 days before randomization.
• Patient in clinical trials of any other drug or device within 3 months before randomization.
• Patient has any condition could prevent, limit, or confound the protocol-specified assessments.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Zhongshan hospital, Shanghai — Шанхай

Идентификаторы

NCT: NCT06895512 · HLX15-IV-NDMM-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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