EUCTR2021-001990-22-GR进行中（未招募）1 期
An Investigator-Initiated, Phase II, Multicenter, Open-Label, Single-Arm, Prospective Clinical Trial to Evaluate the Efficacy and Safety of Alternating Bortezomib-Based Regimens in Combination with DaratUMumab followed by Maintenance with Daratumumab in the Frontline Setting of Primary Plasma CEll LEukemIA: A Trial of the Greek Myeloma Study Group. The EUMELEIA Study - The EUMELEIA ” Study
Hellenic Society of Haematology (HSH)0 个研究点目标入组 43 人开始时间: 2021年6月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 43
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Female or male patients of any race or ethnicity, aged between 18 and 80 years (inclusive) at the time of signing the ICF.
- •2.Patients newly diagnosed with documented pPCL as defined by the current IMWG criteria for PCL and MM [5,34]:
- •2.1 Documented presence of =5% PBPCs and/or absolute number =0.5 × 103/µL (by flow cytometry)
- •2.2 Clonal BMPCs =10% or biopsy-proven bony or extramedullary plasmacytoma (EMP)
- •2.3 At least one of the following myeloma defining events (CRAB or malignancy biomarkers criteria
- •- Evidence of end organ damage that can be attributed to the underlying plasma cell proliferative disorder, specifically (one or more of the following):
- •a) Hypercalcemia: serum calcium >0.25 mmol/L (>1 mg/dL) higher than the upper limit of normal (ULN) or >2.75 mmol/L (>11 mg/dL)
- •b) Renal insufficiency: Creatinine clearance (CrCl) <40 mL/min (measured or estimated by validated equations) or serum creatinine >177 µmol/L (>2 mg/dL)
- •c) Anemia: hemoglobin value of >20 g/L below the lower limit of normal (LLN), or a hemoglobin value <100 g/L
- •d) Bone lesions: One or more osteolytic lesions on skeletal radiography, computed tomography (CT), or positron emission tomography (PET)-CT.
- •- Any one or more of the following biomarkers of malignancy:
- •a) Clonal bone marrow plasma cell percentage =60%
- •b) Involved:Uninvolved serum free light chain (sFLC) ratio =100
- •c) >1 focal lesions on MRI studies (each focal lesion must be 5 mm or more in size).
- •3. Measurable disease by protein electrophoresis as defined by any of the following:
- •3.1 Serum M-protein level:
- •- For IgG MM: =1.0 g/dL or urine M-protein level =200 mg/24 hours
- •- For IgA, IgE and IgM MM: =0.5 g/dL or urine M-protein level =200 mg/24 hours
- •- For IgD MM: =0.05 g/dL or urine M-protein level =200 mg/24 hours
- •3.2 Light chain MM without measurable disease in the serum or the urine: sFLC =10 mg/dL (involved light chain) and abnormal sFLC ?/? ratio.
- •4. Patients for whom high-dose therapy, with or without stem cell transplantation, is part of the intended treatment plan.
- •5. Patient not currently or previously treated with any systemic therapy or stem cell transplant for any plasma cell dyscrasia, apart from a short course of corticosteroid therapy (equivalent of dexamethasone 40 mg/day for up to 4 days).
- •6. Adequate bone marrow function as determined by the following:
- •6.1 Hemoglobin =7.0 g/dL [=4.34 mmol/L; prior red blood cell (RBC) transfusion or recombinant human erythropoietin use is permitted]
- •6.2 Absolute neutrophil count (ANC) =1.0 x 109/L
- •6.3 Platelet count =50 x 109/L if disease involvement in bone marrow is >50%; otherwise =75% x 109/L.
- •7. Adequate liver function as determined by the following:
- •7.1 Serum Aspartate Transaminase (AST) =2.5 x ULN
- •7.2 Serum Alanine Aminotransferase (ALT) =2.5 x ULN
- •7.3 Total bilirubin =1.5 x ULN
- •8. Adequate renal function as determined by estimated CrCl =20 mL/min
- •9. Performance status (PS) according to (ECOG) 0-3
- •10. If females of childbearing potential (FCBP)*, the following apply:
- •10.1 Willingness to use an acceptable form of birth control
- •10.2 They must agree not to donate eggs (ova, oocytes)
- •10.3 They must have 2 negative serum or urine pregnancy tests;
- •11. If male subjects of reproductive potential who are sexually active with FC
排除标准
- •1. Patients with secondary PCL.
- •2. Prior or concurrent invasive malignancy (other than PCL) within 5 years of date of study treatment initiation except for the following:
- •2.1 Malignancy treated with curative intent and with no known active disease present for =3 years before study treatment initiation.
- •2.2 Adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or breast, incidental histologic finding of prostate cancer (T1a or T1b) or other non-invasive lesion that, as per Investigator’s judgement, is considered cured with minimal risk of recurrence over the next 3 years.
- •3. Radiation therapy within 14 days before study treatment initiation.
- •4. Plasmapheresis within 28 days before study treatment initiation.
- •5. Exhibiting clinical signs of meningeal or central nervous system involvement by PCL.
- •6. Patients with peripheral neuropathy or neuropathic pain Grade 2 or higher
- •7. Concurrent systemic amyloidosis, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and/or skin changes), active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease, and any other medical condition/disease that is likely to interfere with the study procedures or results, or that in the opinion of the Investigator, places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
- •8. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second [FEV1] <50% of predicted normal.
- •9. Known moderate or severe persistent asthma within the past 2 years (refer to Appendix 2), or the patient currently has uncontrolled asthma of any classification.
- •10. Any of the following:
- •10.1 Known seropositivity for human immunodeficiency virus (HIV)
- •10.2 Seropositivity for hepatitis B virus (HBV)
- •10.3 Known seropositivity for hepatitis C virus (HCV)
- •11. Clinically significant cardiac disease including:
- •11.1 Myocardial infarction within 6 months before study treatment initiation (C1D1)
- •11.2 Unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association [NYHA] Class III-IV)
- •11.3 Pericardial disease
- •11.4 Cardiac amyloidosis
- •11.5 Uncontrolled cardiac arrhythmia (NCI CTCAE v5 Grade 2 or higher) or clinically significant electrocardiogram (ECG) abnormalities
- •11.6 Screening 12-lead ECG showing a baseline QT interval >470 msec (except for subjects with pacemaker)
- •11.7 Screening transthoracic echocardiogram (TTE) showing left ventricular ejection fraction (LVEF) <40% (screening TTE is required only for subjects aged = 65 years).
- •12. Receipt of a strong CYP3A4 inducer (e.g., rifampicin, carbamazepine, phenytoin, phenobarbital and St. John’s Wort) within 5 half-lives prior to study treatment initiation.
- •13. Known allergies, hypersensitivity, or intolerance to boron or mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective SmPCs and Investigator's Brochure [IB]), or known sensitivity to mammalian-derived products.
- •14. Gastrointestinal disease that may significantly affect the absorption of oral drugs as per Investigator’s discretion.
- •15. Vaccination with live attenuated vaccines within 4 weeks of study treatment initiation.
- •16. Major surgery within 2 weeks before study tre
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