NCT06649695进行中（未招募）2 期
A Phase II Trial of Teclistamab in Participants With Previously Treated Immunoglobulin Light-chain (AL) Amyloidosis
European Myeloma Network B.V.17 个研究点 分布在 6 个国家目标入组 30 人开始时间: 2025年7月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 17
- 主要终点
- Hematologic Complete Response (CR) rate
研究概览
简要总结
This is a multicenter open-label, phase 2 study in participant with previously treated immunoglobulin light-chain (AL) Amyloidosis to evaluate the benefit of teclistamab
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of AL amyloidosis and typed with immunohistochemistry/ immunofluorescence, immunoelectron microscopy, or mass spectrometry. In patients with biopsy-confirmed amyloidosis, ambiguous amyloid typing results, and cardiac involvement alone, a negative pyrophosphate (PYP) or technetium-99m (99mTc) and 3,3-diphosphono-1,2-propanodicarboxylic acid (DPD-Tc99m) bone scan is required to distinguish cardiac involvement due to AL amyloidosis from amyloid transthyretin (ATTR) amyloidosis. Data from the initial diagnosis are accepted.
- •Genetic testing must be negative for transthyretin mutations associated with hereditary amyloidosis, or immunohistochemistry/ immunofluorescence/ immunoelectron microscopy/ mass spectrometry of amyloid deposits must provide clear evidence of κ or λ light chains in patients who present with peripheral neuropathy or heart as the dominant organ involvement. Data from the initial diagnosis are accepted.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or 2
- •Mayo stage I-IIIA cardiac disease at Screening
- •Relapsed patients must have received at least 1 line of treatment, including Dara and bortezomib. Patients must have received at least two cycles of therapy. However, patients who have received high-dose therapy with melphalan as their only therapy are also eligible.
- •Measurable hematologic disease: a dFLC >20 mg/L with an abnormal κ/λ ratio (with Freelite® test kits, The Binding Site) or presence of a monoclonal spike ≥0.5 g/dL.
- •Adequate bone marrow function, without transfusion or growth factors within 5 days prior to the first drug intake (C1D1), defined as:
- •Absolute neutrophils ≥1,000/mm3,
- •Platelets ≥75,000/mm3,
- •Hemoglobin ≥8.5 g/dL.
- •Adequate organ function, defined as:
- •Serum creatinine clearance (CKD-EPI formula) ≥20 mL/min,
- •Serum SGPT/ALT <5.0 x Upper Limit of Normal (ULN),
- •Serum total bilirubin <2.0 mg/dL or direct bilirubin ≤30% of the total, unless the patient has Gilbert's syndrome, where direct bilirubin should then be <2.0 mg/dL,
- •Serum albumin ≥<2.5 gr/dl (medication to correct serum albumin levels is permitted).
排除标准
- •Amyloid-specific syndrome, such as carpal tunnel syndrome or skin purpura, as the only evidence of disease. The finding of isolated vascular amyloid in a bone marrow biopsy specimen or in a plasmacytoma is not indicative of systemic amyloidosis.
- •Isolated soft-tissue involvement.
- •Presence of non-AL amyloidosis.
- •Previous anti-BCMA targeted therapy (including, but not limited to, bispecifics).
- •Intolerance to dexamethasone that would prohibit treatment with trial therapy.
- •MM diagnosed as per the International Myeloma Working Group (IMWG) criteria, with the exception of monoclonal gammopathy of unknown significance (MGUS) or smoldering Myeloma, not requiring treatment.
- •Note: A MM diagnosis with a serum FLC ratio >100, as the only myeloma-defining event, does NOT constitute an exclusion.
- •All hematologic malignancies, with the exception of low-risk Philadelphia chromosome negative (Ph-) myeloproliferative neoplasms (MPNs) and low-risk myelodysplastic syndromes (MDS), not requiring treatment.
- •Mayo stage IIIB cardiac disease at Screening
研究组 & 干预措施
Teclistamab
Experimental
Teclistamab will be administered via a subcutaneous injection (SC)
干预措施: Teclistamab (Drug)
结局指标
主要结局
Hematologic Complete Response (CR) rate
时间窗: baseline up to 3 cycles of treatment (approximately 3 months)
Percentage of participants achieving CR or better according to EHA/ISA guidelines
次要结局
- Hematologic Overall Response Rate (ORR) rate(Baseline up to progression of disease or death (approximately 3,5 years))
研究者
研究点 (17)
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