Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with MIDD

Официальное название

Daratumumab, Bortezomib, Cyclophosphamide, and Dexamethasone Therapy for Patients with Monoclonal Immunoglobulin Deposition Disease

Обзор

This is an open-label, multicenter, Phase 2 study in subjects with newly diagnosed monoclonal immunoglobulin deposition disease treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.

Подробное описание

The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed monoclonal immunoglobulin deposition disease. Approximately 25 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.

Вмешательства

• Препарат Dara-CyBorD
  Patient will receive Dara-CyBorD (Daratumumab, Bortezomib, Cyclophosphamide, Dexamethasone) for at least 6 cycles, and then Daratumumab maintainance. Drug: Daratumumab: 16mg/kg IV dose OR 1800 mg subcutaneously Drug: Cyclophosphamide: 300 mg/m\^2 as an oral or IV dose Drug: Bortezomib: 1.3 mg/m\^2 as an subcutaneous (SC) injection. Drug: Dexamethasone: 20-40mg Patients will receive the above drugs (Dara-CyBorD) on Days 1, 8, 15, 22 in every 28-day cycle for a maximum of 6 cycles. Daratumumab wi

Первичные конечные точки

• Rate of Hematologic Complete Response at the completion of 6 cycles [Срок оценки: 6 months]

Вторичные конечные точки (8)

• Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels [Срок оценки: 6 months]
• Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels [Срок оценки: 6 months]
• Renal response at 6 months [Срок оценки: 6 months]
• Cardiac response at 6 months [Срок оценки: 6 months]
• MRD status at 6 months [Срок оценки: 6 months]
• Renal Survival in 2 years [Срок оценки: 2 years]
• Overall Survival in 2 years [Срок оценки: 2 years]
• TRAEs [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Diagnosis of monoclonal immunoglobulin deposition disease without anti-plasma cell treatment
• ECOG 0,1,2
• Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L.
• Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN;
• Informed consent explained to, understood by and signed by the patient.

Критерии исключения

• Prior therapy for MIDD, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid)
• Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma.
• Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis;
• Severe or persistent infection that cannot be effectively controlled;
• Presence of severe autoimmune diseases or immunodeficiency disease;
• Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]);
• Patients with HIV infection or syphilis infection;
• Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Peking Union Medical College Hospital — Пекин
• Peking University People's Hospital — Пекин
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу

Идентификаторы

NCT: NCT06418477 · 2024PHB134-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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