ACTRN12622001158752招募中1 期
MM25: A phase 1b/II study of the efficacy of Venetoclax, Iberdomide and Dexamethasone (IberVenD) for patients in first or second relapse of Multiple Myeloma with t(11;14)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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. Males or females, age 18 years or older, capable of giving consent
- •2. ECOG performance status of 0 to 2.
- •3. Have confirmed MM as defined by IMWG criteria and have had 1 to 2 prior lines of therapy
- •4. Have measurable disease defined by having at least one of the following:
- •o Serum M-protein concentration of greater than or equal to 5g/L
- •o Urine M-protein excretion of greater than or equal to 200mg/24 hours
- •o Involved serum free light chain (SFLC) greater than or equal to 100mg/L and an abnormal SFLC ratio ( less than 0.26 or
- •greater than 1.65)
- •5. Positive for t(11;14) by fluorescence-in-situ-hybridisation (FISH) testing on bone marrow aspirate sample
- •6. Adequate bone marrow function
- •7. Adequate liver function (ALT/AST equal to 2.5 x Upper limit of normal, Bilirubin equal to 1.5 x Upper limit of normal)
- •8. Adequate renal function (creatinine clearance equal to 30ml/minute)
- •9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following applies
- •o Is not a woman of childbearing potential (WOCBP) or
- •o Is a WOCBP and is using a contraceptive method that is highly effective (with failure rate of less than 1%/year) during the study intervention and for at least 4 months after the last dose of the study drug
- •10. A male participant is eligible to participate if they agree to refrain from donating sperm AND either agree to be abstinent from heterosexual intercourse or agree to use barrier contraception when engaging in sexual activity with a WOCBP (including pregnant females). This female partner must also be using an additional method of highly effective contraceptive method (with failure rate of less than 1%/year).
- •11. Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments
- •12. Signed, written informed consent
排除标准
- •1. Previous treatment with Bcl-2 inhibitor or CELMod
- •2. Any of the following conditions: Non-secretory Multiple Myeloma, solitary plasmacytoma or plasma cell leukaemia.
- •3. Known Central nervous system involvement
- •4. Systemic anti-myeloma therapy within less than or equal to 14 days with the exception of corticosteroids equivalent to dexamethasone less than or equal to 160mg in total within last 4 weeks.
- •5. Major surgery within 14 days of initiating study treatment
- •6. Radiotherapy within 14 days of initiating study treatment
- •7. Female patients who are lactating or have a positive serum pregnancy test during screening period.
- •8. Evidence of cardiovascular risk:
- •o Evidence of current clinically significant untreated arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block;
- •o History of myocardial infarction, acute coronary syndrome (including unstable angina), coronary angioplasty, or stenting or bypass grafting within the last 6 months;
- •o Class III of IV heart failure defined by New York Heart Association functional classification system
- •9. Known immediate or delayed hypersensitivity or allergy to previous drugs chemically related to venetoclax and/or Iberdomide.
- •10. Acute infections requiring antibiotic, antifungal or antiviral therapy within 1 week prior to first dose.
- •11. Known HIV infection.
- •12. Hepatitis B surface antigen positivity or Hepatitis B DNA positivity at screening or within 3 months prior to first dose of study treatment. Participants with positive Hepatitis B core antibody testing can be enrolled if Hepatitis B DNA negative and receiving Hepatitis B prophylaxis.
- •13. Known gastrointestinal disease or procedure that could interfere with the oral absorption or tolerance of iberdomide or venetoclax.
- •14. Use of a strong or moderate CYP3A inhibitor or inducer within 1 week prior to starting first dose of study treatment.
- •15. Diagnosed or treated for another malignancy within 2 years before study enrolment or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •16. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
研究者
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