EUCTR2020-000382-16-DE进行中（未招募）1 期
Efficacy of daratumumab (Dara) retreatment using a histone deacetylase-inhibitor (HDACi: panobinostat) as a Dara-longevity-inducing, epigenetic agent in combination with bortezomib-dexamethasone as a quadruplet in relapsed / refractory multiple myeloma (RRMM) patients - Dara-H-VERUMM
Medical Center - University of Freiburg0 个研究点目标入组 30 人开始时间: 2020年11月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female patients =18 years of age
- •2.Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- •3.Patients with a confirmed diagnosis of multiple myeloma (in line with the revised IMWG criteria) who have received Dara-Rd as relapse treatment in 2nd line and have documented evidence of PD based on the investigator’s determination of response as defined by the IMWG uniform response criteria.
- •(Patients who have received a prior autologous bone marrow transplant and otherwise meet the inclusion criteria are eligible for this study)
- •4.Must have measurable disease defined by at least 1 of the following 3
- •measurements:
- •? Serum M-protein =0.5 g/dL
- •? Urine M-protein =200 mg/24 hours OR
- •? Serum Free Light Chain (FLC) >100 mg/L of involved FLC
- •5.Laboratory test results within these ranges:
- •White blood cell count =2 x 109/L
- •Absolute neutrophil (ANC) count =0.5 x 109/L
- •Platelet count =75 x 109/L
- •Haemoglobin >8 g/dL
- •Calculated creatinine clearance (according to MDRD) =30 mL/minute
- •Total bilirubin =1.5 x upper limit of normal (ULN)
- •AST and ALT =2.5 x ULN
- •Corrected serum calcium level <3.5 mmol/L (<14 mg/dL)
- •6.Women of childbearing potential (WOCBP) must have 2 negative serum pregnancy tests, one 10-14 days prior to start of the study drugs and one within 24 hours prior to the start of study drugs. Women must not be breastfeeding. WOCBP must agree to follow instructions for methods of contraception for 4 weeks before the start of treatment with study drugs, for the duration of treatment with study drugs, and for a total of 3 months after cessation of daratumumab treatment. Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy.
- •7.Written informed consent obtained according to international guidelines and local laws;
- •8.Ability to understand the nature of the trial and comply with the trial related procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1.Plasma cell leukaemia, and/or extensive EM relapse (=multiple, large sites); entirely refractory MM disease, documented systemic light chain amyloidosis, MM involving the central nervous system
- •2.POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •3.Waldenström’s macroglobulinemia or IgM myeloma
- •4.Clinical signs of meningeal involvement of multiple myeloma
- •5.Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) <50% of predicted. (FEV1 testing is, required during screening)
- •6.Known intolerance to or contraindication for the use of bortezomib, or refractory to bortezomib (defined as progressive disease according to IMWG criteria
- •7.Known intolerance to or contraindication for the use of daratumumab, panobinostat, and dexamethasone or any of the other ingredients in the study treatment formulations (known hypersensitivity to the active substances or any of the excipients)
- •8.Life expectancy of <4 months
- •9.Major surgery within 4 weeks prior to cycle 1 day 1
- •10.Subject is known to be seropositive for human immunodeficiency virus (HIV) or has active hepatitis (type A, B or hepatitis C)
- •11.Any serious underlying medical condition, such as:
- •serious active viral, bacterial, or uncontrolled systemic fungal infection
- •severe cognitive disorders
- •severe ventricular arrhythmia
- •12.Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- •13.Any prior or concurrent malignancy other than multiple myeloma.
- •Exceptions include patients who have been disease-free for at least five
- •years before study entry or patients with adequately treated and
- •completely resected basal cell or squamous cell skin cancer, in situ
- •cervical, breast or prostate cancer
- •14.Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
- •15.Known or persistent abuse of medication, drugs or alcohol; Subject is known or suspected of not being able to comply with study protocol
- •16.Current or planned pregnancy, nursing period
- •17.Failure to use one of the following safe methods of contraception: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception
- •Women of childbearing potential can only take part in this study if the risk of becoming pregnant is absolutely minimized. Save contraceptive methods comprise: female condoms, diaphragm or coil, each used in combination with spermicides; intra-uterine device; hormonal contraception in combination with a mechanical method of contraception and have to be used while participating in the study.
- •Men must agree to use a latex condom during sexual contact with females of childbearing potential while participating in this study even if he has undergone a successful vasectomy. Patients must abstain from donating blood, semen, or sperm during participation in the study
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