NL-OMON53051招募中2 期
Efficacy and tolerability of ixazomib, daratumumab and low dose dexamethasone (IDd) followed by ixazomib and daratumumab maintenance therapy until progression for a maximum of 2 years in unfit and frail newly diagnosed multiple myeloma patients; an open-label phase II trial - HOVON 143 MM
HOVO0 个研究点目标入组 112 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 112
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
- •Previously untreated patients with a confirmed diagnosis of multiple myeloma
- •according to IMWG criteria;
- •Measurable disease according to the IMWG criteria;
- •Patients who are either unfit or frail according to the IMWG criteria;
- •Age 18 years or older.
- •Absolute neutrophil count (ANC) >= 1.0 x109/l and platelet count >= 75x109/l.
- •Platelet transfusions and G-CSF to help patients meet eligibility criteria are
- •not allowed;
- •Written informed consent, including consent for additional bone marrow and
- •blood sampling and a skin biopsy
- •Patient is capable of giving informed consent.
- •Negative pregnancy test at study entry (only for women of childbearing
- •potential);
- •Male patients and female patients of childbearing potential must agree to use
- •adequate contraception from the time of signing the informed consent form
- •through 90 days after the last dose of study drug.
排除标准
- •Non-secretory MM;
- •Plasma cell leukemia;
- •Systemic Amyloid Light-chain (AL) amyloidosis;
- •Central nervous system involvement;
- •Known allergy to any of the study medications, their analogues, or excipients
- •in the various formulations of any agent;
- •Neuropathy, grade 1 with pain or grade >= 2;
- •Severe cardiac dysfunction (NYHA classification III-IV);
- •Screening 12-lead ECG showing a baseline QT interval as corrected by
- •Fridericia*s formula (QTcF) >470 msec;
- •Chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume
- •in 1 second (FEV1) < 50% of predicted normal. ;
- •Moderate or severe persistent asthma within the past 2 years or currently
- •uncontrolled asthma of any classification..
- •Significant hepatic dysfunction (total bilirubin >= 3 x ULN or transaminases >=
- •5 times normal level) except patients with Gilbert*s syndrome as defined by >
- •80% unconjugated bilirubin
- •Creatinine clearance <20 ml/min or Calculated Glomerular Filtration Rate
- •[ml/min/1.73m2] <20;
- •Patients with active, uncontrolled infections;
- •Patients known to be Human Immunodeficiency Virus (HIV)-positive;
- •Patients seropositive for hepatitis B, defined by a positive test for
- •hepatitis B surface antigen [HBsAg]. Patients 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 real-time 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.
- •Patients seropositive for hepatitis C (except in the setting of a sustained
- •virologic response [SVR], defined as aviremia at least 12 weeks after
- •completion of antiviral therapy).
- •Known GI disease or GI procedure that could interfere with the oral
- •absorption or tolerance of ixazomib including difficulty swallowing;
- •Active malignancy other than MM requiring treatment or a malignancy that has
- •been treated with chemotherapy currently affecting bone marrow capacity;
- •Systemic treatment, within 14 days before the first dose of ixazomib, with
- •strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine,
- •phenytoin, phenobarbital), or use of St. John*s wort;
- •Pre-treatment with cytostatic drug, immunomodulatory drugs (IMiDs) or
- •proteasome inhibitors. Radiotherapy (provided the involved field is small and
- •there are >= 7 days between radiotherapy and administration of ixazomib) or a
- •short course of steroids (e.g. 4 day treatment of dexamethasone 40 mg/day or
- •equivalent) are allowed;
- •Major surgery within 14 days before enrollment;
- •Any serious medical or psychiatric illness, or familial, sociological and
- •geographical condition potentially hampering compliance with the study protocol
- •and follow-up schedule;
- •Participation in other clinical trials, including those with other
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