JPRN-jRCTs071180034已完成2 期
Efficacy and safety of intensified induction, autologous stem cell transplantation, consolidation and maintenance therapy in patients with newly diagnosed multiple myeloma: a phase2 study - JSCT MM14
Sunami Kazutaka0 个研究点目标入组 55 人开始时间: 2019年3月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
研究概览
简要总结
The study treatment was in some degree effective, but the complete remission after scVRD fell short of the threshold we set. Induction with 4 cycles of scVCD, auto-PBSCT with Bor plus high-dose MEL, and consolidation with scVRD were highly tolerable, despite being intensified treatments.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old（—）
- 性别
- All
入选标准
- •1. Multiple myeloma diagnosed by the criteria of International Myeloma Working Group (IMWG). Age from 20 to 65 years old.
- •2. Measureable M protein in serum or urine or abnormal serum k/l ratio by the serum free light chain measurement.
- •3. Good performance status (0-2). (Patients with poor performance status by the osteolytic lesions can be included.)
- •4. Main Organ function is maintained
- •5. Those who are evaluated to be able to survive more than 3 months.
- •6. 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.
- •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.
排除标准
- •1. Non-secretory MM, plasma cell leukemia, POEMS syndrome, and Waldenstrom Macroglobulinemia.
- •2. Patients with amyloidosis.
- •3. Patients who have been undergoing surgery or radiation treatment within 14 days before participating the study.
- •4. Patients who received prednisolone more than 30mg/day within 14 days before participation.
- •5. Involvement of central nervus system with myeloma cells
- •6. Patients HIV-positive, HBs antigen positive, and HCV antibody positive (except HCV-PCR negative).
- •7. Severe hepatic dysfunction, severe renal failure, severe cardiac dysfunction, severe pulmonary dysfunction, uncontrolled diabetes, uncontrolled hypertension, and uncontrolled infection.
- •8. Patients with a history of active malignancy during the past 5 years.
- •9. Patients with psychiatric disorders such as schizophrenia etc.
- •10. Pregnant women, pre-menopausal women, and lactating women.
- •11. History of hypersensitivity to mannitol or boron.
- •12. Patient was suspected pneumonia (Interstitial pneumonia). Consult a respiratory specialist if necessary
- •13. Those who are considered as inappropriate to register by attending physicians.
研究者
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