JPRN-jRCT2011230049招募中2 期
Phase 2 Multicenter Study on Efficacy and Safety of Combined Isatuximab,Pomalidomide and Dexamethasone Therapy as a Consolidation Therapy after Autologous Peripheral Blood Stem Cell Transplantation for Treatment-Naive Multiple Myeloma
Goto Hideki0 个研究点目标入组 55 人开始时间: 2023年11月19日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 70age old（—）
- 性别
- All
入选标准
- •1)Patients aged between 20 and less than 70 upon acquisition of consent (regardless of sex and hospitalization status).
- •2)Having multiple myeloma satisfying the IMWG diagnostic criteria (2014 revised edition).
- •Satisfying at least one of clonal plasma cells in bone marrow>-10%,osseous or extramedullary plasmacytoma demonstrated by biopsy and the below-given myeloma-defining events 1 or 2.
- •Myeloma-Defining Events
- •[events 1]:Organ failure possibly attributable to plasma cell proliferative disease.
- •-Hypercalcemia: Serum calcium level higher by more than 1 mg/dL than the upper limit of institution normal range (ULN) or higher than 11 mg/dL.
- •-Renal failure: Creatinine clearance < 40 mL/min or serum creatinine > 2 mg/dL.
- •-Anemia: Hemoglobin level lower by more than 2 g/dL than the lower limit of institution normal range (LLN) or lower than 10 g/dL.
- •-Bone lesions: One or more osteolytic lesions revealed by bone X-ray,CT or PET-CT
- •[events 2]:Satisfying at least one of the below-given biomarkers of malignant tumors.
- •-Percentage of monoclonal plasma cells in bone marrow >-60%.
- •-Free light chain ratio in serum >-100.
- •-Two or more focal bone lesions (>-5 mm) revealed by MRI.
- •3) Possible to measure M protein (indicator of responses to treatment) in serum or urine. Or the free light chain
- •concentration ratio in serum is abnormal (kappa/lambda ratio > 4:1 or <1:2).
- •-Serum M protein>-1 g/dL
- •-Urinary M protein>-200 mg (24-hour pooled urine)
- •-Free light chain concentration ratio in serum is abnormal and free light chain concentration >- 100 mg/L
- •4) Never having received treatment of multiple myeloma before (excluding radiotherapy for the purpose of painrelief related to bone lesions).
- •5) ECOG-PS 0 to 2(unless worsening of PS due to osteolytics lesion)
- •6) Internal organs and bone marrow functioning well,satisfying the following criteria:
- •-Absolute neutrophil count: >- 1,000/mm3
- •-Platelet count: >- 75,000/mm3
- •-Hemoglobin: >- 8.0 g/dL
- •-Creatinine clearance: >- 30 mL/min (converted with Cockcroft-Gault formula; eGFR30ml/min may be used as a substitute)
- •-Total bilirubin: Not exceeding twice the upper limit of institution normal range (ULN)
- •*This criterion is not applied to patients diagnosed definirely with Gilbert syndrome (persistent or relapsing
- •hyperbilirubinemia of mainly the unconjugated type,free of hemolysis or pathologic signs of liver).
- •Eligibility to the tria shall be judged by the Principal Investigator/Sub-investigator.
- •-Aspartate aminotransferase (AST) and alanine aminotransferase (ALT): Not exceeding three times theupper limit of institution normal range (ULN).
- •7) Left ventricular ejection fraction (LVEF): >- 50%
- •8) SpO2 >- 93% (without oxygen therapy)
- •9) Expected survival >- 12 weeks
- •10) Female patients are eligible if they are postmenopausal(1 year or more after the last menstruation) or having agreed to comply with RevMate and to take surgical contraceptive measures or other appropriate contraceptive measures(contraceptive agents, devices) during the trial period and for 5 months after completion of the trial. Male patients are eligible if they have agreed to comply with RevMate and to take appropriate contraceptive measures during the trial period.
- •11) Patients having been informed sufficiently about the trial by the Principal Investigator/Sub-investigator using the preset consent form and other leaflets and having issued written consent to participation in the trial at their own discretion.
排除标准
- •1) Patients with symptoms due to amyloidosis and histologically proven amyloid deposition.
- •2) Smoldering IgM myeloma, solitary plasmacytoma,plasmacytic leukemia, POEMS syndrome or Waldenstroem's macroglobulinemia.
- •3) Patients having received more than 20 mg/day steroid(converted to prednisolone dose) within 14 days before provisional enrollment.
- •4) Patients having received surgery (excluding minimaloperative procedures such as tooth extraction) within14 days before provisional enrollment.
- •5) Patients with myeloma cells invading the central nervous system.
- •6) Patients having Grade 2 or severer peripheral neuropathy (PN) at the baseline.
- •7) Patients with poorly controlled diabetes mellitus, hypertension or infection.
- •8) Patients having immunodeficiency or its history
- •9) Patients with severe mental disorders such as schizophrenia(excluding subjects judged by the attending
- •physician as being well controlled by medication).
- •10) Patients with severe or poorly controlled systemic disease(including predisposition to active bleeding, and
- •active infections such as hepatitis B,hepatitis C and human immunodeficiency virus (HIV) infection).
- •11) Patients having received a live attenuated vaccine within 30 days before provisional enrollment.
- •12) Patients with active double cancers at advanced stage(synchronous double cancers, and metachronous double cancers with a disease-free period not exceeding 5 years;provided the lesions of the uterine cervix, stomach or large bowel equivalent to carcinoma in situ and judged as curable by topical therapy shall be excluded from active double cancers).
- •13) Pregnant women, women possible to become pregnant during the trial period or lactating women.
- •14) Other patients judged as inappropriate for the trial by the Principal Investigator/Sub-investigator.
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