Bortezomib, Pomalidomide plus low-dose Dexamethasone versus Bortezomib, Lenalidomide plus low-dose dexamethasone for newly-diagnosed multiple myeloma: A randomized phase III study. - PVd vs VRd

Dr Lalit Kumar0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•a) Newly diagnosed cases of multiple myeloma with no prior chemotherapy (prior treatment with dexamethasone up to 2 weeks is acceptable). Prior localized or palliative radiotherapy is acceptable.
•b)Durie- Salmon stage II and III, ISS stage I,II,III
•c)Age between 18 and 70 years
•d)ECOG performance status of 0 to 2
•e)Serum creatinine of <=2.0 mg/dl
•f)Adequate liver function (serum bilirubin <=1.5 mg/dl, AST and ALT < 2.5 times of upper limit of normal)
•g)Adequate hemogram absolute neutrophil count >1000/ cu. mm. and platelet count >75,000/ cu.mm. and Hb >7g/dl
•h)Pre-existing peripheral neuropathy < grade 2 at the time of enrollment
•i)Pregnancy test negative for female patients of reproductive age
•j)Willing to participate (provide written informed consent)

•a) Prior treatment with Bortezomib, Lenalidomide or Thalidomide
•b)Non-secretory multiple myeloma, monoclonal gammopathy of unknown significance (MGUS), or smoldering myeloma.
•c)Uncontrolled diabetes mellitus
•d)Uncontrolled hypertension, unstable angina, inadequate cardiac function (abnormal ECG: rhythm disturbances), acute myocardial infarction within the last 6 months
•e)Severe psychiatric disorder that would make participation in the study difficult
•f)History of hypersensitivity reaction to mannitol, boron or bortezomib
•g)Patient is pregnant or lactating
•h)Active acute infection requiring systemic antibiotics, antifungals or antivirals within 2 weeks prior to start of study drug

发起方

Dr Lalit Kumar