ACTRN12615000934549进行中（未招募）2 期
A multicentre single arm study to evaluate the safety and efficacy of carfilzomib-thalidomide-dexamethasone (CarTD) for newly diagnosed transplant-eligible multiple myeloma (TE NDMM) patients refractory to initial bortezomib-based induction therapy
Australiasian Leukaemia and Lymphoma Group0 个研究点目标入组 50 人开始时间: 2015年9月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 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
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Male and Female patients, >17 years of age.
- •Symptomatic NDMM as per IMWG criteria.
- •Eligible for high-dose melphalan conditioned ASCT.
- •Failed to achieve at least a minimal response (MR) with a minimum of 2 cycles of a prior bortezomib-based induction therapy or a partial response (PR) with a minimum of 4 cycles of a prior bortezomib-based induction therapy.
- •Adequate liver function (total bilirubin < 1.5 ULN, ALT < 2.5x ULN) unless considered secondary to MM.
- •Absolute neutrophil count > = 1.0 x 109/L within one week of starting therapy.
- •Platelet count > = 50 x 109/L (>= 30 x 109/L if MM involvement in the marrow is greater than 50%) within one week of starting therapy, patients should not have received platelet transfusions within one week of the screening platelet count.
- •Hb >= 80g/L, red cell transfusions as per institutional protocol are allowed.
- •Subject must have LVEF >= 50% determined by 2-D transthoracic echocardiogram (ECHO) or Multigated Acquisition Scan (MUGA).
- •Has provided written informed consent.
- •Women of childbearing potential must have a negative serum pregnancy test within the 72 hours prior to the first study drug administration.
- •Women of childbearing potential and male subjects who are sexually active with WOCBP must agree to use 2 highly effective methods of contraception during the study and for 30 days following the last dose of study treatment including a male condom.
排除标准
- •Patients who have had myocardial infarction within 6 months prior to enrolment, or NYHA (New York Hospital Association) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- •Other uncontrolled intercurrent illness including, but not limited to, severe active infection, or psychiatric illness/social situations that would limit compliance with study requirements
- •Patients with myelodysplastic syndrome.
- •Known history of allergy to Captisol (registered trademark) (a cyclodextrin derivative used to solubilise carfilzomib)
- •Patients with contraindication to dexamethasone.
- •Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- •Women who are pregnant or lactating.
- •Active Hepatitis B or Hepatitis C.
- •HIV infection, other immunosuppressive therapy or autoimmune disease
- •Prior diagnosis of cancer that was:
- •more than 5 years prior to current diagnosis with subsequent evidence of disease recurrence or clinical expectation of recurrence is greater than 10%
- •within 5 years of current diagnosis with the exception of successfully treated basal cell or squamous cell skin carcinoma or carcinoma in situ of the cervix
- •Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. This condition must be discussed with the patient prior to signing consent and registration in the trial.
研究者
相似试验
进行中（未招募）
不适用
Alisporivir con pegIFN / RBV in pazienti con epatite C cronica con precedente fallimento terapeutico all'inibitore della proteasiEUCTR2011-004653-31-ITOVARTIS FARMA173
进行中（未招募）
不适用
Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis CEUCTR2011-004653-31-DEovartis Pharma Services AG173
进行中（未招募）
不适用
Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis CChronic hepatitis C genotype 1 protease inhibitor (PI) treatment failureMedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2011-004653-31-ESovartis Farmacéutica S.A173
进行中（未招募）
不适用
Alisporivir with pegIFN/RBV in protease inhibitor (PI) treatment failure patients with chronic hepatitis CEUCTR2011-004653-31-GBovartis Pharma Services AG173
尚未招募
Unknown
A single-center clinical study to evaluate the safety and efficacy of autologous bone marrow-derived DCs(CellgramDC-WT1) and immune checkpoint inhibitors in patients with metastatic pancreatic cancer who have failed first-line or more standard chemotherapyKCT0009102Soon Chun Hyang University Hospital Seoul10