A Study of F182112 in the Treatment of Patients With Relapsed or Refractory Multiple Myeloma

Официальное название

A Phase II Study of F182112 Combined With Different Administration Regimens in Patients With Relapsed or Refractory Multiple Myeloma

Обзор

This is a single - arm, multi - cohort, open - label, multi - center Phase II clinical study. It aims to evaluate the efficacy and safety of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Подробное описание

The study plans to enroll approximately 90 patients with relapsed or refractory multiple myeloma at around 20 study centers.

Primary objective:

The objective response rate (ORR) of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma.

Secondary objective:

The efficacy of F182112 combined with different administration regimens in patients with relapsed or refractory multiple myeloma (complete response rate \[CRR\], progression - free survival \[PFS\], overall survival \[OS\], duration of response \[DOR\], time to response \[TTR\], time to progression \[TTP\], minimal residual disease - negative rate); The incidence and grade of adverse events (AE), serious adverse events (SAE), abnormal laboratory test indicators.

Вмешательства

• Препарат F182112+P
  F182112 + P
• Препарат F182112+CD38
  F182112+CD38

Первичные конечные точки

• Objective response rate (ORR) [Срок оценки: up to 2 years]

Вторичные конечные точки (5)

• Progression - Free Survival（PFS） [Срок оценки: Up to 2 years]
• Minimal Residual Disease - negative rate [Срок оценки: Up to 2 years]
• Number of Participants With Adverse Events and Serious Adverse Events [Срок оценки: Up to 2 years]
• Overall Survival（OS） [Срок оценки: Up to 2 years]
• Duration of Response（DOR） [Срок оценки: up to 2 years]

Критерии участия

Критерии включения

• Be diagnosed with multiple myeloma according to the IMWG 2016 criteria.
• The previous treatment regimen must contain lenalidomide (lenalidomide must be used continuously for at least 2 cycles) and a proteasome inhibitor.
• Participants whose previous treatment regimen contained pomalidomide or who were intolerant to pomalidomide cannot be enrolled.
• Have an ECOG performance status score of 0 - 2.
• Meet at least one of the following measurable disease indicators:

• Serum M - protein ≥ 5 g/L.
• Urine M - protein ≥ 200 mg/24 h.
• Serum free light chain (FLC) test: Involved FLC level ≥ 100 mg/L and abnormal serum free light chain ratio (< 0.26 or > 1.65).

Критерии исключения

• Patients with primary light - chain amyloidosis or plasma cell leukemia .
• Patients with symptoms of central nervous system involvement of multiple myeloma.
• Patients with a history of other malignancies other than multiple myeloma within 3 years before the first dose.
• Patients with active mucosal or visceral bleeding.
• Patients who have previously received BCMA - targeted therapy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Hematology & Blood Diseases Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07312188 · NTP-F182112-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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