Phase1/2study evaluating safety and efficacy of bortezomib-lenalidomid-dexamethasone induction therapy followed by lenalidomide-dexamethasone consolidation and lenalidomide maintenance for newly diagnosed patients with multiple myeloma eligible for stem cell transplantation.

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital0 个研究点目标入组 30 人开始时间: 2015年3月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1.multiple myeloma defined by IMWG criteria.
•2.aged from 20 to 65 years old.
•3.PS(ECOG)0-2.(Patients with poor P.S. by bone pain accompanying myeloma can be included.)
•4.Main organ function is maintained
•Absolute neutrophil counts >1000/mm
•Platelet counts>75,000/mm3
•T-bil < 3 times upper limit of normal standard
•AST and ALT < 5 times upper limit of normal standard
•Serum Creatinine <2mg/dl
•5. The patient who lives more than three months
•6. The patient who can follow the RevMate
•7. In patients receiving the notice, fully briefed for the consent document and other documents given explanation about the contents of the study physician or study investigator, agreed in writing to voluntarily participate in the study by having been obtained.
•8.The HBc antibody and HBs antibody-positive patient is eligible for guidelines on conformity

•1.non-secretary multiple myeloma or plasmacytoma or plasma cell leukemia, POEMS syndrom
•2.HBs antigen,HCV antibody positive
•3.HTLV-1 antibody, HIV antibody positive
•4.Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
•5.Patients with a history of active malignancy during the past 5 years.
•6.Patients with psychiatric disorders such as schizophrenia etc.
•7.Pregnant women, pre-menopausal women, and lactating women.
•8.History of hypersensitivity to mannitol or boron.
•9.dialysis patient
•10.Patient of the vein thrombosis
•11.Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
•12.Those who are considered as inappropriate to register by attending physicians.

发起方

Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital