DRKS00020561进行中（未招募）2 期
Efficacy of Daratumumab (dara) retreatment using a histone deacytelase-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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 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
- •- Hemoglobin >8 g/dL
- •- Calculated creatinine clearance (according to MDRD) =30
- •- 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 the last study drug. Males who are sexually active with
- •WOCBP must use during the duration of the study and up to 3 months
- •afterwards a latex or synthetic condom during any sexual contact with
- •females of reproductive potential, even if they have undergone a
- •successful vasectomy.
- •Patients must abstain from donating blood, semen, or sperm during
- •participation in the study
- •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 trialrelated
- •procedures.
排除标准
- •1. Plasma cell leukemia, 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. Patients that are eligible for autologous stem cell transplantation (aSCT)
- •7. Known intolerance to or contraindication for the use of bortezomib, or
- •refractory to bortezomib (defined as progressive disease according to
- •IMWG criteria
- •8. 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)
- •9. Life expectancy of <4 months
- •10. Major surgery within 4 weeks prior to cycle 1 day 1
- •11. Subject is known to be seropositive for human immunodeficiency virus
- •(HIV) or has active hepatitis (type A, B or hepatitis C)
- •12. Any serious underlying medical condition, such as:
- •- serious active viral, bacterial, or uncontrolled systemic fungal
- •infection (including SARS-CoV-2)
- •- severe cognitive disorders
- •- severe ventricular arrhythmia
- •13. Participation in any other interventional clinical trial within the last 30
- •days before the start of this trial
- •14. 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
- •15. Patient without legal capacity who is unable to understand the nature,
- •significance and consequences of the trial
- •16. Known or persistent abuse of medication, drugs or alcohol; Subject is
- •known or suspected of not being able to comply with study protocol
- •17. Current or planned pregnancy, nursing period
- •18. Failure to use one of the following safe methods of contraception: intrauterine
- •device; intrauterine hormone-releasing system ( IUS), hormonal
- •contraception in combination with a mechanical method of
- •contraception, bilateral tubal occlusion, sexual abstinence
- •Women of childbearing potential can only participate in this study if the risk
- •of becoming pregnant is absolutely minimized.
研究者
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