JPRN-jRCTs071190019进行中（未招募）2 期
Efficacy and safety of ixazomib, lenalidomide and dexamethasone (ILd) combination therapy for the relapsed and refractory multiple myeloma patients undergoing lenalidomide maintenance - W-JHS MM02
Shibayama Hirohiko0 个研究点目标入组 25 人开始时间: 2019年8月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 25
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 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who are >=20 years of age
- •2) Patients who understand the informed consent and can sign the informed consent form on their own free will.
- •3) Patients who follow the protocol visit schedule and other rules.
- •4) MM patients with treatment history of 1-2 regimens and with more than or equal to PR to latest treatment and who meet either or both of Clinical response or Biochemical response of the following treatment start criteria at relapse during low-dose lenalidomide therapy (<=10 mg/day) (or within 60 days after lenalidomide discontinuation)(Concomitant use of dexamethasone is acceptable)
- •5) Good ECOG PS 0,1,or 2
- •6) Female patients with childbearing potential (who are sexually mature, and a) have not received hysterectomy or bilateral oophorectomy or b) have not passed more than or equal to 24 months after natural menopause (amenorrhea after cancer treatment is not relevant) (menstruation within 24 months) who meet the following requirements:
- •Patients who can agree to receive pregnancy test twice before study drug administration (first test is carried out 10 - 12 days before, and second test is carried out within 24 hours before study drug administration). In addition, patients who can agree to receive pregnancy test during treatment period and after discontinuation of study administration, and can also agree to receive pregnancy test if they refrain completely from sex with their partner.
- •7) Male patients who meet the following requirements:
- •Patients who can agree to completely refrain from sex with their partner*, or can agree to use of condoms when having sex with their partner during treatment period (including cessation period) and for 90 days after discontinuation of study administration, unless they received complete vasectomy.
- •Patients who agree not to provide seminal fluid or sperm during treatment period (including cessation period) and for 28 days after the discontinuation of study drug administration.
- •*Defined as no sex at all during the specified period. The condition that sexual relations are refrained from based on the menstrual cycle and the basal body temperature is not included (in these cases,effective contraception measures are required in case of sexual relations).
排除标准
- •1)Patients with MM treatment history of more than or equal to 3 prior regimens** (excluding radiotherapy (topical radiotherapy is eligible), bisphosphonate administration, short-term administration of steroid alone (less than same titer with dexamethasone 40 mg/day, 4 days, and the administration was carried out more than or equal to 15 days before start of study drug administration)
- •**If the series of remission induction, autologous transplantation, consolidation therapy, and maintenance therapy were originally planned and carried out, all of these are counted as 1 regimen.
- •2)Patients with treatment history of ixazomib
- •3)Patients in whom PD is observed at doses of more than 10 mg/day of lenalidomide in maintenance therapy
- •4)Major surgery within 14 days before enrollment
- •5)Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days will be considered a sufficient interval between treatment and administration of ixazomib
- •6)Systemic treatment, within 14 days before the first dose of ixazomib, with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of St. Johns wort.
- •7)Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
- •8)Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib including difficulty swallowing.
- •9)Patients with, laboratory test abnormality (abnormal levels of more than or equal to Grade 3 in CTCAE ver. 5.0), mental disease
- •10)Patients having a severe disease (including laboratory test abnormality) thought to be exposed to unacceptable risks if he/she participates in the study. The following diseases correspond to the criterion, but the criterion is not limited to these diseases:
- •Myocardial infarction, New York Heart Association (NYHA) classification III or IV heart failure, uncontrollable atrial fibrillation, or hypertension within 6 months before study drug administration
- •Diseases (such as rheumatoid arthritis, multiple sclerosis, lupus) for which chronic treatment with steroid and immunosuppressant is necessary and it is predicted that the treatment would be necessary during the study drug administration period
- •11)Female patients who are pregnant or nursing or have a positive serum pregnancy test during the screening period
- •12)Patients with any of the following laboratory test abnormalities:
- •Neutrophil <1000/mm3
- •Platelet before transfusion <50,000/mm3 (7 days passed after platelet transfusion)
- •AST or ALT >3 X ULN
- •13)Patients with renal failure requiring hemodialysis or peritoneal dialysis or eGFR <20 mL/min/1.73m2
- •14)Patients with anamnesis of malignant tumor other than MM (excluding skin basal cell carcinoma, spinocellular carcinoma, carcinoma in situ of uterine cervix, non-invasive breast cancer, accidental histological finding of prostate cancer (TNM staging T1a or T1b), early gastric cancer for which endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) is applicable). However, they are eligible if disease-free period of more than or equal to 3 years has passed.
- •15)Patients who are unable to receive or shall not be receiving antithrombotic therapy
- •16)Patients with Grade 2 or more peripheral neuropathy and Grade 1 peripheral neuropathy with pain
- •17)Patients with incontrollable systemic fungal/bacterial/viral infection (patients with persistent signs and symptoms despite appropriate treatment such as antim
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