Study of Daratumumab (JNJ-54767414 (HuMax® CD38) in Combination with VELCADE, Thalidomide. and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects with Newly Diagnosed Multiple Myeloma - IFM 2015-01/HOVON 131 MM

Intergroupe Francophone du Myelome (IFM)0 个研究点目标入组 300 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•- diagnosis of previously untreated multiple myeloma (MM)
•- have a confirmed diagnosis and eligible for high dose chemotherapy and
•autologous stem cell transplantation, and an Eastern Cooperative Oncology Group
•(ECOG) performance status score of 0, 1 or 2

•- previous treatment for Multiple Myeloma
•- Primary amyloidosis, Plasma Cell Leukemia or Smoldering Multiple Myeloma
•- Prior or concurrent exposure to systemic therapy or SCT for any plasma cell
•dyscrasia, with the exception of an emergency use of a short course (equivalent
•of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before
•treatment, or received an investigational drug or used an invasive
•investigational medical device within 4 weeks before Cycle 1, Day 1
•- history of malignancy (other than Multiple Myeloma) within 10 years before
•the date of randomization, except for the following if treated and not active:
•basal cell or nonmetastatic squamous cell carcinoma of the skin, cervical
•carcinoma in situ, ductal carcinoma in situ of breast, or International
•Federation of Gynecology and Obstetrics (FIGO) Stage 1 carcinoma of the cervix
•- known chronic obstructive pulmonary disease (COPD) or moderate to severe
•- any concurrent medical or psychiatric condition or disease (eg, autoimmune
•disease, active systemic disease, myelodysplasia) 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

发起方

Intergroupe Francophone du Myelome (IFM)