2024-519191-90-00招募中2 期
A Phase II Trial of Teclistamab in participants with previously treated Immunoglobulin Light-Chain (AL) Amyloidosis
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale8 个研究点 分布在 5 个国家目标入组 24 人开始时间: 2025年4月22日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 8
- 主要终点
- The hematologic CR rate at the completion of 3 cycles (M3) of teclistamab, according to current criteria for response in AL amyloidosis.
研究概览
简要总结
To assess the hematologic CR rate after 3 cycles of single-agent teclistamab in patients with previously treated AL amyloidosis.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
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.
- •Age ≥ 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0,1 or
- •Mayo stage I–IIIA cardiac disease at Screening (see Appendix K for the definition of Mayo stages of cardiac disease).
- •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.
- •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.
- •At least one symptomatic organ involvement (heart, kidney, liver, gastrointestinal [GI] tract or peripheral nervous system) (see Appendix B for the definition of symptomatic organ involvement).
- •A wash-out period of at least 14 days from the date of the last administration of any previous antitumor therapy or investigational treatment, meaning that the patient must not have received any treatment for AL amyloidosis for at least 14 days prior to Cycle 1 Day 1 (C1D1) of this trial.
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 (see Appendix K for the definition of Mayo stage IIIB of cardiac disease).
结局指标
主要结局
The hematologic CR rate at the completion of 3 cycles (M3) of teclistamab, according to current criteria for response in AL amyloidosis.
The hematologic CR rate at the completion of 3 cycles (M3) of teclistamab, according to current criteria for response in AL amyloidosis.
次要结局
- • The time to hematologic response, defined as the time from the date of C1D1 to the date of the first efficacy evaluation during which the patient has met all criteria for hematologic PR, VGPR or CR. Patients without a hematologic response will be censored, either at the date of PD or, in the absence of PD, at the last evaluable disease assessment.
- • The hemPFS, defined as the time from the date of C1D1 to the date of first documentation of hematologic PD, or death due to any cause, whichever occurs first. Patients who are still alive and not yet progressed will be censored at the last disease assessment.
- • The MOD-PFS, defined as the time from the date of C1D1 to hematologic PD, manifestation of cardiac/renal failure, or death, whichever occurs first. For alive and MOD-PFS-free patients, censoring will be considered at the last adequate disease assessment.
- • The MOD-EFS, defined as the time from the date of C1D1 to hematologic PD, manifestation of cardiac/renal failure, initiation of subsequent therapy for amyloidosis, or death, whichever occurs first. For alive and MOD-EFS-free patients, censoring will be considered at the last adequate disease assessment.
- • The TST, defined as the time from the date of C1D1 to the date of initiation of subsequent therapy. Death due to PD (including cardiac/renal failure as per MOD-PFS definition) without the start of subsequent therapy will be considered as an event. Patients who withdrew trial consent, were lost to follow-up or died due to causes other than PD, will be censored at the date of death or at the date last known to be alive.
- • The OS, defined as the time from the date of C1D1 to the date of patient’s death. Patients who are alive or with unknown vital status will be censored at the date last known to be alive.
- • The safety and tolerability of teclistamab, by type, frequency, severity, relationship of adverse events to trial treatment, and changes in vital signs and physical exams.
- • The MRD negativity rate by NGF, defined as the proportion of patients achieving negative MRD at the completion of 3 cycles of treatment with Teclistamab.
- • The changes in QoL using EORTC QLQ30, EQ-5D-5L, and SF-36v2.
- • The hematologic ORR, defined as the proportion of patients achieving a best hematologic response of PR or better, at the completion of 1 (M1), 3 (M3), and 6 cycles (M6), and every 3 months thereafter.
- • The VGPR rate, defined as the proportion of patients achieving a best hematologic response of VGPR or better, at the completion of 1 (M1), 3 (M3), and 6 cycles (M6), and every 3 months thereafter.
- • The duration of hematologic response, defined as the time from the date of initial documentation of hematologic PR, VGPR, or CR, to the date of first documented evidence of hematologic progressive disease (PD). For patients who have not progressed, data will be censored at the last disease assessment.
- • The rate of organ response according to standard criteria, defined as the proportion of patients achieving an organ response among patients with corresponding organ involvement, at the completion of 1 (M1), 3 (M3) and 6 cycles (M6), and every 3 months thereafter. For heart and kidney, the depth of response will be presented at the completion of 1 (M1), 3 (M3) and 6 cycles (M6), and every 3 months thereafter, based on the criteria mentioned on Table 16
研究者
Dr. Murielle Roussel
Scientific
European Myeloma Network B.V.
研究点 (8)
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