A Clinical Study Comparing SG301 Plus Pomalidomide and Dexamethasone to Placebo Plus Pomalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients

Официальное название

A Phase 3 Randomized, Placebo-controlled, Double-blind, Multicenter Study Comparing SG301 in Combination With Pomalidomide and Dexamethasone Versus Placebo in Combination With Pomalidomide and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Обзор

The purpose of this study is to evaluate the effects of the addition of SG301 injection to pomalidomide and dexamethasone in subjects with relapsed or refractory multiple myeloma.

Подробное описание

This is a randomized, placebo-controlled, double-blind, multicenter phase III clinical study to compare SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least 1 prior treatment regimen with both lenalidomide and a proteasome inhibitor and have demonstrated disease progression.

This study consists of two stages. Stage 1 is the dose exploration stage to confirm the recommended stage 2 dose of SG301 injection in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Stage 2 is the randomized controlled stage of SG301 injection in combination with pomalidomide and dexamethasone versus placebo in combination with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

Вмешательства

• Препарат SG301 Injection
  Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
• Препарат SG301 placebo
  Dosage form: solution for infusion Route of administration: intravenous Frequency: weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) thereafter.
• Препарат pomalidomide
  Dosage form: capsule Route of administration: oral Dosage: 4 mg Frequency: once daily on Days 1 through 21 of each 28-day cycle.
• Препарат dexamethasone
  Dosage form: tablets or solution for infusion Route of administration: oral or intravenous Dosage: 40 mg (participants with BMI \< 18.5 kg/m2 received 20 mg dexamethasone) Frequency: once daily on Day 1, 8, 15, 22 of each 28-day treatment cycle.

Первичные конечные точки

• Adverse events （stage 1） [Срок оценки: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.]
• Recommended stage 2 dose of SG301 (Stage 1) [Срок оценки: Up to approximately 6 months.]
• Progression Free Survival (Stage 2) [Срок оценки: From baseline through the end of study. Assessed every 4 weeks after randomization until C19D1, and every 8 weeks thereafter until disease progression (IMWG criteria) or death whichever occurs first, assessed up to approximately 4 years.]

Вторичные конечные точки (9)

• Pharmacokinetics (PK): AUC [Срок оценки: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.]
• Pharmacokinetics (PK): Cmax [Срок оценки: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.]
• Pharmacokinetics (PK):limination half-life (T1/2) [Срок оценки: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.]
• Immunogenicity endpoints [Срок оценки: From date of first dose of study intervention through approximately 30 days after last study intervention administration, assessed up to approximately 4 years.]
• Overall Response Rate [Срок оценки: From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.]
• Percentage of Participants With Very Good Partial Response (VGPR) or Better (≥VGPR Rate) [Срок оценки: From baseline through the end of study. It is measured from the start of treatment until disease progression, death, initiation of further anti-myeloma treatment, or cut-off date, whichever occurs first, assessed up to approximately 4 years.]
• Duration of Response [Срок оценки: From baseline through the end of study. It is measured from the time that the criteria for objective response are first met until the date of a progression event, assessed up to approximately 4 years.]
• Overall Survival [Срок оценки: From baseline through the end of study, assessed up to approximately 4 years.]
• Percentage of Participants With Minimal Residual Disease (MRD) [Срок оценки: From baseline through the end of study. It is measured from the time that the criteria for CR are first met until the date of a progression event, assessed up to approximately 4 years.]

Критерии участия

Критерии включения

• Understand and voluntarily sign the informed consent form (ICF).
• Males and females aged 18-75 years (inclusive)
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2
• Expected survival time of ≥3 months.
• Subjects had a documented diagnosis of multiple myeloma with evidence of measurable disease.
• Subjects had received at least 1 prior lines of anti-myeloma therapy, which must include lenalidomide and a proteasome inhibitor (bortezomib, carfilzomib or ixazomib) given alone or in combination.
• Subjects must have documented evidence of PD on or after the last regimen.
• Adequate function of vital organs
• Women of childbearing potential (WOCBP) must agree to follow instructions for methods of contraception for 4 weeks before the start of study treatment, for the duration of study treatment, and for 6 months after cessation of SG301 or 4 weeks after cessation of pomalidomide, whichever is longer. WOCBP must have 2 negative serum or urine pregnancy tests, one 10-14 days prior to start of study treatment and one 24 hours prior to the start of study treatment.

Критерии исключения

• Primary refractory multiple myeloma defined as participants who had never achieved at least a minimal response (MR) with any treatment during the disease course.
• Bone independent extramedullary disease at screening.
• Subjects who are primary refractory to a prior CD38 monoclonal antibody therapy.
• Previous exposure to pomalidomide.
• Subject has received chemotherapy or small molecule antitumor therapy within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
• Subject has received tumor biotherapy within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter, before the first dose of study treatment;
• Subject has received investigational agents within 4 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is shorter (but not less than 14 days), before the first dose of study treatment;
• Active hepatitis B, or C.
• Known HIV infection.
• Known active tuberculosis or positive treponema pallidum antibodies.
• Subjects with clinical significant organ dysfunction that does not meet the study needs.
• Previous allogenic stem cell transplant or autologous stem cell transplantation (ASCT) before the first dose of study treatment.
• Known allergy to any component of the investigational medicinal product.
• Any concurrent medical or psychiatric condition or disease (eg, 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.

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 · 12 центров

• Beijing Chaoyang Hospital of Capital Medical University — Пекин
• Guangzhou First People's Hospital — Гуанчжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• First Affiliated Hospital of Henan University of Science and Technology — Luoyang
• Henan Cancer Hospital — Чжэнчжоу
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Ухань
• The First Affiliated Hospital Of Soochow University — Сучжоу
• Shanxi Provincial Hospital — Taiyuan
• … и ещё 4 центра

Идентификаторы

NCT: NCT06508983 · CSG-301-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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