Ixazomib citrate-thalidomide-low dose dexamethasone induction followed by maintenance therapy with ixazomib citrate or placebo in newly diagnosed multiple myeloma patients not eligible for autologous stem cell transplantation; a randomized phase II trial - HOVON 126 MM/ NMSG 21.13

HOVO0 个研究点目标入组 71 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 71

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

•- Previously untreated patients with a confirmed diagnosis of symptomatic
•multiple myeloma according to IMWG criteria
•- Measurable disease according to the IMWG criteria (If plasmacytoma is the
•only measurable parameter, the patient is not allowed to be included in the
•study, because of difficult response evaluation).
•- Age * 66 years or patients * 65 years not eligible for ASCT
•- WHO performance status 0-3 for patients <75 years and WHO performance status
•0-2 for patients * 75 years
•- Absolute neutrophil count (ANC) * 1.0 x109/l and platelet count * 75x109/l ,
•unless related to bone marrow infiltration by malignant plasmacells .
•- Written informed consent.
•- Patient gives consent for extra bone marrow and blood sampling.
•- Negative pregnancy test at study entry or at least 1 year post-menopausal or
•surgically sterile before study entry
•- Patients must use adequate contraception as specified in the protocol (all
•men and all women of childbearing potential)

排除标准

•- Known allergy to any of the study medications, their analogues, or excipients
•in the various formulations of any agent
•- Systemic AL amyloidosis
•- Polyneuropathy, grade 3 or higher or grade 2 with pain on clinical
•examination during the screening period
•- Evidence of current uncontrolled cardiovascular conditions, including
•uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic
•congestive heart failure, unstable angina, or myocardial infarction within the
•past 6 months
•- Severe pulmonary dysfunction (Modified Medical Research Counsil dyspnea scale
•classification III-IV)
•- Significant hepatic dysfunction (total bilirubin * 1.5 x ULN or transaminases
•* 3 times normal level) except patients with Gilbert*s syndrome as defined by >
•80% unconjugated bilirubin
•- Creatinine clearance <30 ml/min or Calculated Glomerular Filtration Rate
•[ml/min/1.73m2] <30
•- Systemic treatment, within 14 days before the first dose of ixazomib, with
•strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine,
•phenytoin, phenobarbital), or use of Ginkgo biloba or St. John*s wort.
•- Pre-treatment with cytostatic drug, IMIDs or proteasome inhibitors.
•Radiotherapy or a short course of steroids (e.g. 4 day treatment of
•dexamethasone 40 mg/day or equivalent) are allowed. Radiotherapy should not be
•given within 14 days before enrollment. In case of radiotherapy, if the
•involved field is small, 7 days will be considered a sufficient interval
•between treatment and administration of the ixazomib citrate
•- Not able and/or not willing to use adequate contraception
•- Female patients who are lactating or have a positive serum pregnancy test
•during the screening period,
•- Major surgery within 14 days before enrollment.
•- Central nervous system involvement.
•- Ongoing or active systemic infection, active hepatitis B or C virus
•infection, or known human immunodeficiency virus (HIV) positive.
•- Known GI disease or GI procedure that could interfere with the oral
•absorption or tolerance of ixazomib citraat including difficulty swallowing.
•- Diagnosed or treated for another malignancy within 2 years before study
•enrollment or previously diagnosed with another malignancy and have any
•evidence of residual disease. Patients with nonmelanoma skin cancer or
•carcinoma in situ of any type are not excluded if they have undergone complete
•- Participation in other clinical trials, including those with other
•investigational agents not included in this trial, within 21days of the start
•of this trial and throughout the duration of this trial.
•- Any serious medical or psychiatric illness, or familial, sociological and
•geographical condition potentially hampering compliance with the study protocol
•and follow-up schedule

研究者

发起方

HOVO

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