NL-OMON54540招募中2 期
Phase 2 study of daratumumab monotherapy in previously untreated patients with stage 3B light chain (AL) amyloidosis - EMN22
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
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 64（—）
入选标准
- •1. Men or women 18 years of age or older., 2. Diagnosis of amyloidosis, AL
- •type, based on:, a. Histopathological diagnosis of amyloidosis based on
- •detection by immunohistochemistry and polarizing light microscopy of green
- •bi-refringent material in Congo Red stained tissue specimens (excluding bone
- •marrow) or characteristic electron microscopy appearance, AND, b. Measurable
- •disease of amyloid light chain amyloidosis as defined by at least ONE of the
- •following: , - serum monoclonal protein >=0.5 g/dL by protein electrophoresis
- •(routine serum protein electrophoresis and immunofixation performed at local
- •lab), - 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). Serum FLCs will be measured using the Freelite
- •assay at a central laboratory., - Note: Measurable disease by Urine Bence-Jones
- •Proteinuria is not sufficient for study enrolment. , AND, c. Cardiac
- •involvement by AL amyloidosis according to consensus guidelines (See ATTACHMENT
- •3), 3. Mayo Stage 3B disease, defined as both A. increased cardiac troponin
- •(hsTnT >54 pg/ml) AND B. increased NT-proBNP >= 8500 pg/ml, 4. For subjects
- •with congestive heart failure, symptoms should be optimally managed and
- •clinically stable with no cardiovascular-related hospitalizations within 2
- •weeks prior to Cycle 1 Day 1, as assessed by the Principal Investigator. [See
- •also exclusion criteria 3], 5. Eastern Cooperative Oncology Group (ECOG)
- •Performance Status (PS) 0, 1,2 or 3 (ATTACHMENT 1), 6. Subject must have
- •pre-treatment clinical laboratory values meeting the following criteria during
- •the Screening Phase:, a. Absolute neutrophil count >=1.0 × 109/L;, b. Hemoglobin
- •level >=8.0 g/dL (>=5 mmol/L), c. Platelet count >=75 × 109/L; platelet
- •transfusions are NOT acceptable, d. Alanine aminotransferase level (ALT) <=2.5 x
- •ULN;, e. Aspartate aminotransferase (AST) <=2.5 x ULN, f. Total bilirubin level
- •<=1.5 × ULN, except for subjects with history of Gilbert Syndrome, in which case
- •direct bilirubin <= 2 × ULN, g. Estimated Glomerular Filtration Rate (eGFR) >=20
- •mL/min; Please note that the eGFR is measured by using the CKD-EPI equation ,
- •7. Women of childbearing potential must commit to either abstain continuously
- •from heterosexual sexual intercourse (if this is the preferred and usual
- •lifestyle of the subject) or to use 2 methods of reliable birth control
- •simultaneously. This includes one highly effective form of contraception (tubal
- •ligation, intrauterine device, hormonal [birth control pills, injections,
- •hormonal patches, vaginal rings or implants] or partner*s vasectomy) and one
- •additional effective contraceptive method (male latex or synthetic condom,
- •diaphragm, or cervical cap). Contraception must begin prior to dosing and
- •continue for 3 months after discontinuation of daratumumab. Reliable
- •contraception is indicated even where there has been a history of infertility,
- •unless due to hysterectomy or bilateral oophorectomy., 8. During the study and
- •for 3 months after receiving the last dose of daratumumab, female subjects must
- •agree not to donate eggs (ova, oocytes) for the purposes of assisted
- •reproduction., 9. A man who is sexually active with a woman of childbearing
- •potential and has not had a vasectomy
排除标准
- •1.Prior therapy for AL amyloidosis or multiple myeloma with the exception of
- •160 mg dexamethasone (or equivalent steroid) maximum exposure prior to Cycle 1
- •Day 1., 2.Previous or current diagnosis of symptomatic multiple myeloma
- •including the presence of lytic bone disease, plasmacytomas, >= 60% plasma cells
- •in the bone marrow, and/or hypercalcemia., 3.Evidence of significant
- •cardiovascular conditions as specified below:, a. New York Heart Association
- •(NYHA) classification of heart failure, stages IIIB or IV , b. Heart failure
- •that in the opinion of the investigator due to ischemic heart disease or
- •uncorrected valvular disease, and not due to AL amyloid cardiomyopathy., c.
- •Hospitalization for unstable angina or myocardial infarction or percutaneous
- •cardiac intervention with recent stent or coronary artery bypass grafting, all
- •within the last 6 months prior to the first dose , d. Subjects with a history
- •of sustained ventricular tachycardia or aborted ventricular fibrillation or
- •with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal
- •dysfunction for which a pacemaker/ICD is indicated but will not be placed
- •(subjects who do have a pacemaker/ICD are allowed in the study), e. Screening
- •12-lead ECG showing a baseline QT interval as corrected by Fridericia*s formula
- •(QTcF) >500 msec. Subjects who have pacemaker may be included regardless of
- •calculated QTc interval., f. Supine systolic blood pressure <90 mmHg, or
- •symptomatic orthostatic hypotension, defined as a decrease in systolic blood
- •pressure upon standing of >20 mmHg despite medical management in the absence
- •of volume depletion, 4. Subjects planning to undergo a stem cell transplant
- •during the first 6 cycles of protocol therapy are excluded. Stem cell
- •collection during the first 6 cycles of protocol therapy is permitted., 5.
- •Diagnosed or treated for malignancy other than AL, except:, a. Malignancy
- •treated with curative intent and with no known active disease present for >=24
- •months before Cycle 1 Day 1, b. Adequately treated non-melanoma skin cancer or
- •lentigo maligna without evidence of disease, c. Adequately treated carcinoma in
- •situ (e.g. cervical, breast) with no evidence of disease, 6. Subject has known
- •chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in
- •1 second (FEV1) <50% of predicted normal. Note that FEV1 testing is required
- •for subjects suspected of having COPD and subjects must be excluded if FEV1
- •<50% of predicted normal, 7. Subject has known moderate or severe persistent
- •asthma within the past 2 years or currently has uncontrolled asthma of any
- •classification. (Note that subjects who currently have controlled intermittent
- •asthma or controlled mild persistent asthma are allowed in the study)., 8.
- •Subject is known to be seropositive for human immunodeficiency virus (HIV). HIV
- •positive subjects who are stable on highly active antiretroviral therapy
- •(HAART) with no opportunistic infections within the last 6 months are
- •eligible. , 9. Subjects known: a. To be seropositive for hepatitis B (defined
- •by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with
- •resolved infection (ie, subjects who are HBsAg negative but positive for
- •antibodies to hepatitis B core antigen [antiH-Bc] and/or antibodies to
- •hepatitis B surface antigen [anti-HBs]) mu
研究者
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