A Phase IIb, open label, sequential cohort study comparing KappaMab alone to KappaMab in combination with lenalidomide and low dose dexamethasone (MRd) in Relapsed Refractory Multiple Myeloma

Dr Andrew Spencer - Alfred Hospital0 个研究点目标入组 59 人开始时间: 2016年8月26日最近更新: 2023年1月16日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 59

研究概览研究设计入排标准研究者记录与标识符相似试验

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. Age 18 years and above.
•2. Confirmed diagnosis of MM as per IMWG criteria,
•3. ECOG performance status 0-2
•4. Relapsed and/or refractory kappa restricted MM
•5. Received 1-3 prior lines of therapy
•a. Induction + ASCT + maintenance = 1 line of therapy
•b. (No prior lenalidomide therapy)
•6. Adequate liver and kidney function (<2 x institutional upper limit of normal)
•7. Platelet count > 75 x 10^9/L, absolute neutrophil count > 1.0 x 109/L
•8. No contraindication to the use of KappaMab, lenalidomide or dexamethasone
•9. Patient has voluntarily agreed and has given written informed consent.
•10. Life expectancy of > 8 weeks
•11. Patient must be > 2 weeks from prior chemotherapy, radiotherapy, biological therapy, immunotherapy, major surgery or any other investigational anti-cancer therapy prior to the first dose of study drug
•12. All females of childbearing potential (FOCBP)** must agree to have two medically supervised negative pregnancy tests : one at screening, patient undertaking contraceptive controls and one 24 hours prior to dosing of study drug. Patient must use two reliable methods of contraception simultaneously or to practice complete abstinence from any sexual contact during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide
•13. All male participants must practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following study drug discontinuation, even if he has undergone a successful vasectomy.

排除标准

•1. Patients with monoclonal gammopathy of uncertain significance.
•2. Primary amyloidosis
•3. Patients who have received prior allogeneic transplantation
•4. Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•5. Patients with a prior malignancy within the last 5 years (except for basal or squamous cell carcinoma or in situ cancer of the cervix).
•6. Pregnant or lactating women.
•7. Known hepatitis B, Hepatitis C, HIV infection, other immunosuppressive therapy or autoimmune disease

研究者

发起方

Dr Andrew Spencer - Alfred Hospital

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