Evaluation of Ixazomib, Lenalidomide, Dexamethasone Induction and extended Consolidation followed by Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma Patients =65 years eligible for High Dose Therapy: a phase II study of the Intergroupe Francophone du Myélome (IFM)

CHU de Toulouse0 个研究点目标入组 46 人开始时间: 2015年6月22日最近更新: 2020年9月28日

试验速览

暂无简介。

•-Male or female patients = 18 years and = 65 years at the time of signing informed consent form
•- Patients diagnosed with multiple myeloma based on the new International Myeloma Working Group Diagnostic Criteria for plasma cells disorders (leukemia 2009)
•-Subjects must have symptomatic myeloma with CRAB criteria
•- Subjects must have measurable disease requiring systemic therapy defined by serum M-component = 5g/l or urine M-component = 200 mg/24h or serum FLC = 100 mg/l.
•-Subjects must not have been treated previously with any systemic therapy for multiple myeloma. Prior treatment with corticosteroids or radiation therapy does not disqualify the subject (the maximum dose of corticosteroids should not exceed the equivalent of 160 mg of dexamethasone in a 2-week period before initiation therapy). Two weeks must have elapsed since the date of the last radiotherapy treatment
•-Subjects must be eligible for high dose therapy.
•-Life expectancy = 3 months
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 46
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•-Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test
•-Evidence of mucosal or internal bleeding and/or platelet refractory.
•-Prior myeloma systemic therapy
•-Central nervous system involvement
•-Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to first dose of study drug=
•-Infection requiring systemic antibiotic therapy or other serious infection within 14 days before first dose of study drug.
•-Evidence of current uncontrolled cardiovascular conditions...
•-Systemic treatment, within 14 days before first dose of study drug, with strong inhibitors of CYP1A2, strong inhibitors of CYP3A or strong CYP3A inducers or use of Ginkgo biloba or St. John’s wort
•-Ongoing or active systemic infection, known human immunodeficiency virus (HIV) positive, known active hepatitis B virus hepatitis, or known active hepatitis C virus hepatitis and history of hepatitis B or C virus hepatitis.
•-Diagnosed or treated for another malignancy within 5 years before study enrollment
•-Patient has significant neuropathy

发起方

CHU de Toulouse