Efficacy and safety of new drugs for induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed elderly symptomatic multiple myeloma: phase 2 study - FBMTG EMM17

Tanimoto Kazuki0 个研究点目标入组 49 人开始时间: 2019年3月5日最近更新: 2023年10月17日

研究概览

暂无简介。

•All the following criteria MUST be met:
•1) Symptomatic multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG).
•2) Measureable M protein in serum or urine.
•3) Good performance status (0-2). (Patients with bad performance status by the osteolytic lesions can be included.)
•4) Age: 66-75 years old
•5) Main Organ function is maintained
•6) Those who are evaluated to be able to survive more than 3 months.
•7) For female patients, postmenopausal (patients older than one year from the last menstrual period), or the proper way or surgical contraception (birth control pills, contraceptives, etc.) has the intention of contraception during the study. For male patients, to agree the appropriate method of contraception during the study.
•8) 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 have been obtained.

•1) Non-secretory MM and plasma cell leukemia.
•2) Patients HIV-positive
•3) Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
•4) Patients with a history of active malignancy during the past 5 years.
•5) Patients with psychiatric disorders such as schizophrenia etc.
•6) Pregnant women, pre-menopausal women, and lactating women.
•7) History of hypersensitivity to mannitol or boron.
•8) Patient was suspected pneumonia(Interstitial pneumonia). Consult a respiratory specialist if necessary
•9) Those who are considered as inappropriate to register by attending physicians.
•10) Pregnant women and cases that may become pregnant or breastfeeding during the study period.
•11) Cases with a history of hypersensitivity tomannitol or boron.
•12) Clinical findings include pneumonia (interstitial pneumonia), cases with pulmonary fibrosis, or chest CT (high resolution CT) with bilateral abnormal interstitial shadows (ground glass or lines) regardless of the presence or absence of symptoms. Cases with (shadow) (consult with a specialist doctor such as respiratory organs if necessary).
•13) Cases with grade 2 or higher peripheral neuropathy at baseline.
•14) Other cases that the doctor in charge judged to be inappropriate.

发起方

Tanimoto Kazuki