EUCTR2017-004203-41-CZ进行中（未招募）1 期
A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination with Standard Multiple Myeloma Treatment Regimens
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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.>18 years of age (or the legal age of consent if it is higher than 18 years of age in the jurisdiction in which the study is taking place)
- •2.MM diagnosed according to the IMWG diagnostic criteria
- •3.Measurable,secretory disease as defined by any of the following:
- •-Serum M-protein level =1.0 g/dL;or
- •-Urine M-protein level =200 mg/24 hours; or
- •-Light chain MM, for subjects without measurable disease in the serum or urine: serum Ig free light chain (FLC) =10 mg/dL and abnormal FLC ratio
- •4.a.For inclusion into the D-VRd cohort for newly diagnosed disease: - Newly diagnosed MM by IMWG criteria and eligible/planned for high dose therapy and ASCT
- •4.b.For inclusion into the D-VMP cohort: - Newly diagnosed and previously untreated MM by IMWG criteria and not considered a candidate for high-dose chemotherapy with ASCT due to:Being age =65years, or in subjects <65 years: presence of important comorbid condition(s) will make stem cell transplant intolerable for the subject
- •4.c.For inclusion into the D-Rd cohort for relapsed or refractory disease: •Subject must have received at least 1 prior line of therapy for MM•Subjects must have progressed from or be refractory to their last line of treatment•Subject must have achieved a response (PR or better based on investigator’s evaluation of response by the IMWG criteria) to at least 1 prior treatment regimen
- •4.d. For inclusion in the D-Kd cohort for relapsed or refractory disease:
- •-Subject must have received only 1 prior line of therapy for MM which included at least 2 consecutive cycles of lenalidomide therapy
- •-A single line of therapy may consist of 1 or more agents,and may include induction,hematopoietic stem cell transplantation, and maintenance therapy.Radiotherapy, bisphosphonate,or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 mg/day for 4days)would not be considered prior lines of therapy.
- •-Subject must have achieved a response (PR or better based on investigator’s evaluation of response by the IMWG criteria) to the first treatment regimen
- •-Subject must have progressed from or be refractory to the first line of treatment. •Relapsed disease is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment •Refractory disease is defined as confirmed PD by IMWG criteria during previous treatment or =60 days after cessation of treatment
- •5.ECOG Performance Status grade of 0,1,or2
- •6.Pre-treatment clinical laboratory values during the Screening Phase(all cohorts):
- •a.hemoglobin =7.5g/dL (=4.65mmol/L); D-Kd cohort 8.0 g/dL (without prior RBC transfusion within 7days before the laboratory test;recombinant human erythropoietin use is permitted)
- •b.absolute neutrophil count =1.0×109/L (prior growth factor support is permitted)
- •c. platelet count for D-Rd,D-Kd and D-VRd cohorts: >75×109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells;otherwise platelet count >50×109/L (transfusions are not permitted within 7days of testing to achieve this minimum platelet count);for the D-VMP cohort:platelet count =70x109/L for subjects in whom <50% of bone marrow nucleated cells are plasma cells;otherwise platelet count >50×109/L (transfusions are not permitted within 7 days of testing to achieve this minimum platelet count
- •d.aspartate aminotransferase =2.5×ULN
- •e.alanine aminotransferase =2.5×ULN
- •f.For the D-Rd cohort: total bilirubin =2.0×ULN; except in subjects with congenital bilirubi
排除标准
- •1.Prior or concurrent exposure to any of the following:
- •-Daratumumab or other anti-CD38 therapies
- •-Approved or investigational treatments for MM within 2 weeks of Cycle 1 Day 1
- •-Maximum of 40 mg dexamethasone daily for a maximum of 4 days up to 21 days prior to the 1st dose
- •-Investigational drug or an invasive investigational medical device within 4 weeks or 5 half-lives before Cycle 1 Day 1, or is currently enrolled in another investigational study
- •-ASCT within 12 weeks before the date of administration of study treatment, or allogeneic stem cell transplant (regardless of timing) for the D-Rd and D-Kd cohorts
- •-For D-Rd cohort, only: Refractory to lenalidomide, or who are intolerant to lenalidomide while on lenalidomide treatment are not eligible for the lenalidomide-containing cohorts
- •-For D-Kd cohort, only: Subject has previously received carfilzomib
- •2.History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease.
- •3.Exhibits clinical signs of meningeal involvement of MM.
- •4.Either of the following:
- •-Chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) is <50% of predicted normal.
- •-Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification
- •For D-Kd cohort: Known infiltrative pulmonary disease or known pulmonary hypertension.
- •5.Any of the following:
- •-Known to be seropositive for human immunodeficiency virus;
- •-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 [Anti-HBc] and/or
- •antibodies to hepatitis B surface antigen [Anti-HBs]) must be screened using realtime polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects
- •with serologic findings suggestive of HBV vaccination (Anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
- •6.Known to be seropositive for hepatitis C (anti-HCV antibody positive or HCV-RNA quantitation positive), except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
- •7.Concurrent medical or psychiatric condition or disease that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study
- •8.Clinically significant cardiac disease, including:
- •-myocardial infarction within 6 months before Cycle 1 Day 1, or an unstable or uncontrolled disease/condition related to or affecting cardiac;
- •-uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities; or screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia’s formula (QTc) >470 msec.
- •For D-Kd cohort only:
- •-Transthoracic echocardiogram showing left ventricular ejection fraction (LVEF) <40%
- •-Uncontrolled hypertension, defined as an average systolic blood pressure >159 mmHg or diastolic >99 mmHg despite optimal treatment
- •9. Allergies,hypersensitivity, or intolerance to any of the study drugs,hylauronidase, monoclonal antibodies,human proteins, or their excipients or known sensit
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