ACTRN12621001037897招募中2 期
An immune-therapeutic salvage strategy for ‘functional’ high-risk (FHR) multiple myeloma incorporating Iberdomide, Isatuximab, and Dexamethasone (Iber-IsaDex) – the IBIS study
Australasian Myeloma Research Consortium0 个研究点目标入组 50 人开始时间: 2021年8月6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
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male and Female patient greater or equal to 18 years of age
- •2. Able to provide written consent.
- •3. Myeloma patients who have progressed as per IMWG criteria within 12 months of commencing first line of therapy.
- •4. Measurable disease as define by any of the following:
- •- Serum M-component greater than 5 g/L, and/or
- •- Urine M-component greater than 200 mg/24 h, and/or
- •- Involved serum FLC level greater than100mg/L.
- •5. No contraindication to the use of any of the study drugs and able to comply with trial requirements.
- •6. Adequate liver function (total bilirubin less than 2.0x ULN, ALT less than 5.0x ULN) unless considered secondary to MM.
- •7. Absolute neutrophil count equal to or greater than 1.0 x 10^9/L
- •8. Platelet count equal to or greater than 50 x 10^9/L (equal to or greater than 30 x 10^9/L if MM involvement in the marrow is greater than 50%), patients should not have received platelet transfusions within 7 days of the screening platelet count.
- •9. Hb equal to or greater than 80g/L, red cell transfusions as per institutional protocol are allowed.
- •10.Has provided written informed consent.
- •11.Women of childbearing potential must have a negative serum pregnancy test within the 72 hours prior to the first study drug administration, during treatment and after treatment
- •12.Women of childbearing potential and male subjects who are sexually active with WOCBP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom.
排除标准
- •1.Patients who have had myocardial infarction within 6 months prior to enrolment, or New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
- •2.Any other serious or uncontrolled medical or psychiatric illness that could, in the investigators’ opinion, potentially interfere with the completion of treatment according to this protocol.
- •3.Known ongoing or active systemic infection, active hepatitis B or C infection, or known human immunodeficiency positivity.
- •4.Women who are pregnant or lactating. Women of child-bearing potential must have a negative urine pregnancy test at Screening.
- •5.Any patient who is unable or unwilling to meet the requirements of the IBER pregnancy prevention programme.
- •6.Active malignancy with the exception of any of the following:
- •Adequately treated basal cell carcinoma, squamous cell carcinoma or in situ cervical cancer.
- •Adequately treated stage 1 cancer from which the subject is currently in remission from and has been in remission for > 2 years.
- •Stage 1 prostate cancer that does not require treatment.
- •Any other cancer from which the subject has been disease-free for > 2 years.
- •7.Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
- •8.Participation in other clinical trials for the treatment of multiple myeloma, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial.
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