A phase 2 study of Belantamab Mafodotin in patients with relapsed or refractory AL amyloidosis - EMN27

Stichting European Myeloma Network (EMN)0 个研究点目标入组 2 人开始时间: 待定最近更新: 2024年4月9日

试验速览

阶段: 2 期
状态: 尚未招募
发起方
入组人数: 2

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 18 至 99（—）

入选标准

•1.Diagnosis of AL amyloidosis, confirmed by histology and typed with
•immunohistochemistry, immunoelectron microscopy or mass spectrometry, or if not
•available, for patients with biopsy confirmed amyloidosis and cardiac
•involvement alone, if they also have a negative PYP- or DPD-Tc99m bone scan.
•2..Patients must have had at least two cycles of therapy directed against
•plasma cell clone. However, patients that have received high dose therapy with
•melphalan as their only therapy are also eligible. 3.Patients must be 18 years
•of age or above. 4.ECOG performance status 0, 1 or 2. 5.Mayo stage 1 or Mayo
•stage 2 or Mayo stage 3A1-3 defined as both cTnT < 0.035 ng/mL (or in place of
•cTnT the cTnI < 0.10 ng/mL or high sensitivity Troponin T < 54 ng/L) AND
•simultaneous NT-proBNP <= 332 ng/L, OR EITHER above threshold, or BOTH above
•threshold but with NTproBNP < 8500 ng/L (stage 3A disease) 6.Supine systolic
•blood pressure >= 90 mmHg. 7.Measurable disease defined by at least one of the
•following: a.serum free light chain (FLC) >=2.0 mg/dL (20 mg/L) with an abnormal
•kappa:lambda ratio or the difference between involved and uninvolved free light
•chains (dFLC) >=2mg/dL (20 mg/L). b.presence of a monoclonal spike that is >=0.5
•g/dl. 8.Symptomatic organ involvement (heart, kidney, liver/GI tract,
•peripheral nervous system). 9.Written informed consent in accordance with local
•and institutional guidelines. 10.Female patients: contraceptive use should be
•consistent with local regulations regarding the methods of contraception for
•those participating in clinical studies. A female patient is eligible to
•participate if she is not pregnant or breast-feeding, and at least one of the
•following conditions applies: a.She is not of childbearing potential (WOCBP) OR
•b.She is a WOCBP and using, during the intervention period and for at least 4
•months after the last dose of the trial, a contraceptive method that is highly
•effective (failure rate <1% per year), preferably with low user dependency (as
•described in Appendix 3). Patient agrees not to donate eggs (ova, oocytes) for
•the purpose of reproduction during this period. The investigator should
•evaluate the effectiveness of the contraceptive method in relationship to the
•first dose of trial intervention. A WOCBP must have a negative highly sensitive
•serum-pregnancy test (as required by local regulations) 72 hours before the
•first dose of the trial intervention. The investigator is responsible for
•reviewing the medical history, menstrual history, and recent sexual activity to
•decrease the risk for inclusion of a woman with a nearly undetected pregnancy.
•Nonchildbearing potential is defined as follows (by other than medical
•reasons): a.>=45 years of age and has not had menses for >1 year b.Patients who
•have been amenorrhoeic for <2 years without a history of hysterectomy and
•oophorectomy must have a follicle stimulating hormone value in the
•postmenopausal range after screening evaluation c.Post-hysterectomy,
•post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or
•oophorectomy must be confirmed with medical records of the actual procedure or
•confirmed by an ultrasound. Tubal ligation must be confirmed with medical
•records of the actual procedure. 12. Male patients: contraceptive use should be
•consistent with local regulat

排除标准

•1.Presence of non-AL amyloidosis. 2.Presence of lytic bone lesions or active
•myeloma with hypercalcemia, cast nephropathy, anemia due to marrow infiltration
•or extramedullary disease > 60% plasma cells in bone marrow. 3.Previous
•exposure to anti-BCMA agents 4.Cardiac stage IIIB disease: both cTnT > 0.035
•ng/mL (or in place of cTnT the cTnI > 0.10 ng/mL or high sensitivity Troponin T
•> 54 ng/L) AND simultaneous NT-proBNP >8500 ng/L. 5.Known repetitive
•ventricular arrhythmias on 24h Holter Electrocardiograms (ECG) despite
•anti-arrhythmic treatment. Patient must not have evidence of cardiovascular
•risk including any of the following: •Evidence of current clinically
•significant uncontrolled arrhythmias, including clinically significant ECG
•abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree
•atrioventricular (AV) block. •History of myocardial infarction, acute coronary
•syndromes (including unstable or uncontrolled angina), coronary angioplasty, or
•stenting or bypass grafting within three (3) months of screening. •Class III or
•IV heart failure as defined by the New York Heart Association functional
•classification system (NYHA, 1994). •Severe uncontrolled ventricular
•arrhythmias, sick sinus syndrome, electrocardiographic evidence of acute
•ischemia or Grade 3 conduction system abnormalities (unless patient has a
•pacemaker). •Uncontrolled hypertension or hypotension (i.e., supine SBP< 90
•mmHg despite supportive therapy with midodrine) 6.Significant neuropathy
•(Grades 3-4, or Grade 2 with pain) within 14 days prior to Cycle 1 Day 1.
•7.Pleural effusions requiring thoracentesis or ascites requiring paracentesis
•within 14 days prior to Cycle 1 Day 1. 8.Ongoing corneal epithelial disease
•except mild changes in corneal epithelium (mild punctate keratopathy).
•9.Current unstable liver or biliary disease defined by the presence of ascites,
•encephalopathy, coagulopathy, hypoalbuminemia (except due to related nephrotic
•syndrome), esophageal or gastric varices, persistent jaundice, or cirrhosis.
•Note: Stable non-cirrhotic chronic liver disease (including Gilbert*s syndrome
•or asymptomatic gallstones) or hepatobiliary involvement of malignancy is
•acceptable if otherwise meets entry criteria. 10.Active renal condition
•(infection, requirement for dialysis or any other condition that could affect
•the patient*s safety) unrelated to AL amyloidosis. Patients with isolated
•proteinuria resulting from AL are eligible, provided they fulfil other
•inclusion criteria. 11.Patient must not use contact lenses while participating
•in this trial. 12.Patient must not be simultaneously enrolled in any
•interventional clinical trial. 13.Use of an investigational drug or approved
•systemic anti-myeloma therapy (including systemic steroids) within 14 days or
•five half-lives, whichever is shorter, prior to the first dose of trial drug.
•14.Plasmapheresis within seven days prior to the first dose of the trial
•treatment. Serious conditions unrelated to AL, such as SARS-CoV-2, may be
•permitted but need to be discussed with the medical doctor and trial-site
•personnel. 15.Treatment with a monoclonal antibody within 30 days prior to the
•first dose of the trial treatment 16.Major surgery <= 4 weeks prior to
•initiating trial treatment. 17.Evidence of active mucosal or internal bleeding
•18.Known immediate o

研究者

发起方

Stichting European Myeloma Network (EMN)

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