A randomized phase III non-inferiority trial assessing lenalidomide, bortezomib and dexamethasone induction therapy with either intravenous or subcutaneous isatuximab in transplant-eligible patients with newly diagnosed multiple myeloma - GMMG-HD8/DSMM-XIX

Ruprecht-Karls-Universität Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg0 个研究点目标入组 514 人开始时间: 2023年2月21日最近更新: 2024年5月13日

适应症

试验速览

暂无简介。

•- Confirmed diagnosis of untreated MM requiring systemic therapy (diagnostic criteria according to IMWG)
•- Patient is eligible for HDM (200 mg/m2 melphalan) and ASCT
•- Measurable MM disease according to IMWG criteria, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:
•- Serum M-protein = 10 g/L
•- Urine light-chain (M-protein) of = 200 mg/24 hours
•- Serum FLC assay: involved FLC level = 10 mg/dL provided sFLC ratio is abnormal
•- Age 18-70 years at trial inclusion
•- WHO performance status 0-2
•- Negative pregnancy test at inclusion in women of childbearing potential
•- For all men and women of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy
•- All patients must agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy
•- Ability of patient to understand character and individual consequences of the clinical trial
•- Written informed consent (must be available before enrolment in the trial)
•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 412
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 102

•- Systemic AL amyloidosis
•- Plasma cell leukemia
•- Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local MM progression.
•- Severe cardiac dysfunction
•- Significant hepatic dysfunction
•- HIV positivity
•- Patients with active, uncontrolled infections
•- Patients with severe renal insufficiency or requiring hemodialysis
•- Patients with peripheral neuropathy or neuropathic pain, grade 2 or higher
•- Patients with a history of any active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy.

发起方

Ruprecht-Karls-Universität Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg