A Phase 1/2 study of induction therapy with Thalidomide, Melphalan and Prednisolone for newly diagnosed multiple myeloma patients ineligible for hematopoietic stem cell transplantation

Fujimoto Pharmaceutical Corporation0 个研究点目标入组 100 人开始时间: 2015年2月4日最近更新: 2023年10月17日

试验速览

暂无简介。

•Key inclusion criteria
•1. Patients with symptomatic multiple myeloma as of IMWG diagnostic criteria
•2. Patients with multiple myeloma received no prior treatment with chemical therapeutics.
•3. Patients older than 65, or those between 20 and 64 ineligible for hematopoetic stem cell transplantation
•4. Serum M-protein >= 500 mg/dL or urinary M-protein excretion >= 200 mg/24h
•5. ECOG Performance Status (PS) 0-2 or 3 with osteolytic lesions
•6. Patients who have submitted the informed consent to Thalidomide Education and Risk Management System

•1. Patients who have received any thalidomide preparation
•2. Patients who have received other drugs for multiple myeloma treatment
•3. Patients in pregnancy or lactation
•4. Patients who have the medical history of deep vein thrombosis / pulmonary embolism
•5. Patients who are positive for hepatitis B antigen, hepatitis C antibody, or HIV antibody
•6. White blood cell < 2,000 /mm3, Neutrophil < 1,000 /mm3 or Platelet < 50,000 /mm3
•7. Serum creatinine > 3.0 x ULN
•8. Serum AST or ALT > 3.0 x ULN
•9. Patients under uncontrollable conditions

发起方

Fujimoto Pharmaceutical Corporation