EUCTR2017-003950-18-IT进行中（未招募）1 期
Efficacy of Daratumumab in Patients with Relapsed/Refractory Myeloma with Renal Impairment - The DARE study
HELLENIC SOCIETY OF HEMATOLOGY0 个研究点目标入组 38 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
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. Males and females at least 18 years of age.
- •2. Voluntary written informed consent before performance of any study-related procedure.
- •3. Subject must have documented relapsed or refractory multiple myeloma as defined by the criteria
- •a) Monoclonal plasma cells in the bone marrow = 10% or presence of a biopsy proven
- •plasmacytoma.
- •b) Measurable disease as defined by any of the following:
- •o Serum monoclonal paraprotein (M-protein) level = 1.0 g/dL (except for IgA subtype: =
- •0.5 g/dL) or urine M-protein level = 200 mg/24 hours; or
- •o Light chain multiple myeloma: Serum immunoglobulin free light chain = 10 mg/dL and
- •abnormal serum immunoglobulin kappa lambda free-light-chain ratio.
- •4. Prior treatment with at least two lines of treatment that included both bortezomib- and
- •lenalidomide-based regimens.
- •5. Documented evidence of progressive disease (PD) as defined by the IMWG 2014 on or after the
- •last regimen if the patient responded to previous regimens.
- •6. Renal impairment defined as eGFR < 30 ml/min/1.73 m2 (calculated with the CKD-EPI formula) or in need for dialysis. Patients who undergo intraperitoneal dialysis may also be included.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status score of = 2.
- •8. Willingness and ability to participate in study procedures.
- •9. Reproductive Status
- •a) Women of childbearing potential (WOCBP) must have two negative serum or urine
- •pregnancy tests, one 10-14 days prior to start of the study drug and one within 24 hours prior
- •to the start of study drug. Females are not of reproductive potential if they have been in
- •natural menopause for at least 24 consecutive months, or have had a hysterectomy and/or
- •bilateral oophorectomy.
- •b) Women must not be breastfeeding.
- •c) 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
- •3 months after cessation of study treatment.
- •d) Males who are sexually active 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. They must also 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 90 days post-treatment completion. The additional contraception of female partners of childbearing potential should also be considered.
- •e) Male patients must not donate sperm for up to 90 days post treatment completion.
- •f) Female patients must not donate eggs for up to 90 days post treatment completion.
- •g) Azoospermic males and WOCBP who are not heterosexually active are exempt from
- •contraceptive requirements. However, WOCBP will still undergo pregnancy testing
- •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 11
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
排除标准
- •1. Previous therapy with daratumumab or other anti-CD38 therapy.
- •2. Anti-myeloma treatment within 2 weeks prior to Cycle 1, Day 1.
- •3. Cumulative dose of corticosteroids greater than or equal to the equivalent of 140mg prednisone
- •for =4 days or a dose of corticosteroids greater than or equal to the equivalent of 40 mg/day of
- •dexamethasone for =4 days within the 2-week period prior to Cycle 1, Day 1.
- •4. Previous allogenic stem cell transplant; or Autologous Stem Cell Transplantation (ASCT) within
- •12 weeks before Cycle 1, Day 1.
- •5. Clinical signs of meningeal involvement of multiple myeloma.
- •6. Chronic obstructive pulmonary disease (COPD), persistent asthma, or a history of asthma within
- •7. Clinically significant cardiac disease, including:
- •a) Myocardial infarction within 1 year, or unstable or uncontrolled condition (e.g., unstable
- •angina, congestive heart failure, New York Heart Association Class III-IV).
- •b) Cardiac arrhythmia (CTCAE Grade 2 or higher) or clinically significant ECG abnormalities.
- •c) ECG showing a baseline QT interval as corrected by Fridericia¿s formula (QTcF) >470 msec.
- •8. Any of the following:
- •a. Known active hepatitis A
- •b. Patient is seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
- •c. Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).
- •9. Known to be seropositive for human immunodeficiency virus (HIV).
- •10. Amyloidosis, or any prior or concurrent malignancy, except for the following:
- •a) Adequately treated basal cell or squamous cell skin cancer.
- •b) Any cancer (other than in-situ) from which the subject has been disease-free for 3 years prior
- •to study entry.
- •11. Any of the following laboratory test results during Screening:
- •a) Absolute neutrophil count =1.0 × 109/L;
- •b) Hemoglobin level =7.5 g/dL (=4.65 mmol/L);
- •c) Platelet count <75 × 109/L in patients in whom <50% of bone marrow nucleated cells are
- •plasma cells and <50x109/L in patients in whom more than 50% of bone marrow nucleated
- •cells are plasma cells;
- •d) Alanine aminotransferase level =2.5 times the upper limit of normal (ULN);
- •12. Pregnant or nursing women.
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