EUCTR2013-003265-34-CZ进行中（未招募）1 期
Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) forinduction and consolidation followed by Pomalidomide combined withDexamethason vs Pomalidomide maintenance for patients with MultipleMyeloma in progression after prior 1st line treatment with Lenalidomideand Bortezomib. - EMN11/HO114
Stichting Hemato-Oncologie voor Volwassenen Nederland (Hovon)0 个研究点目标入组 222 人开始时间: 2015年10月7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
- 222
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
- •- Included in EMN02/HO95 trial. Induction therapy followed by
- •autologous stem cell transplant (AutoSCT) and consolidation/
- •maintenance will be considered as one regimen.
- •- The subject must understand and voluntarily sign an informed consent
- •document prior to any study related assessments/procedures.
- •- Age = 18 years at the time of signing the informed consent form.
- •- Able to adhere to the study visit schedule and other protocol
- •requirements.
- •- Documented diagnosis of multiple myeloma and measurable disease
- •(serum M-protein = 10 g/L or urine M-protein = 200 mg/24 hours or
- •abnormal FLC ratio with involved free light chain (FLC) > 100 mg/L) or
- •proven plasmacytoma by biopsy).
- •- Documented progression or refractory multiple myeloma as per the
- •IMWG uniform response criteria (Durie, 2006) during or after the
- •EMN02/HO95 trial;
- •- Normal renal function with a Creatinine Clearance > 45mL/min
- •according to the Modification of Diet in Renal Disease (MDRD) equation
- •for estimation of Glomerular Filtration Rate (GFR)
- •- WHO performance status score of 0, 1 or 2.
- •- Patients must be willing and capable to use adequate contraception
- •during the therapy (all men, all pre-menopausal women).
- •- Patients must be able to adhere to the requirements of the Pregnancy
- •Prevention Risk Management Plan.
- •- Patients must be eligible for autologous stem cell transplantation when
- •not previously given in first line treatment.
- •- All subjects must agree to refrain from donating blood while on study
- •drug and for 28 days after discontinuation from this study treatment.
- •- All subjects must agree not to share medication.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Patient received more than 1 regimen (EMN02/HO95), except local
- •radiotherapy.
- •- Absolute neutrophil count (ANC) <1.0 x 109/L, unless related to MM.
- •- Platelet count < 75 x 109/L, unless related to MM.
- •- Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L).
- •- Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or
- •recombinant human erythropoietin use is permitted).
- •- Significant hepatic dysfunction (Serum SGOT/AST or SGPT/ALT > 3.0 x
- •upper limit of normal (ULN) or serum total bilirubin > 3.0 x ULN)
- •- Prior history of malignancies, other than MM, unless the subject has
- •been free of the disease for = 5 years. Exceptions include the following:
- •Basal or squamous cell carcinoma of the skin, carcinoma in situ of the
- •cervix or breast, Incidental histological finding of prostate cancer (TNM
- •stage of T1a or T1b).
- •- Previous therapy with pomalidomide or carfilzomib.
- •- Hypersensitivity to thalidomide, lenalidomide, bortezomib or
- •dexamethasone (this includes = Grade 3 rash during prior thalidomide or
- •lenalidomide or bortezomib therapy).
- •- Peripheral neuropathy = Grade 2.
- •- Subjects who received an allogeneic bone marrow or allogeneic
- •peripheral blood stem cell transplant less than 12 months prior to
- •initiation of study treatment
- •- LVEF = 40%.
- •- QTc > 450 msec.
- •- History of torsade de pointes.
- •- History of ventricular tachycardia, ventricular fibrillation.
- •- Uncontrolled atrial fibrillation/flatter.
- •- Congestive heart failure (NY Heart Association Class III or IV).
- •- Myocardial infarction within 12 months prior to starting study
- •- Unstable or poorly controlled angina pectoris, including Prinzmetal
- •variant angina pectoris.
- •- History of pulmonary hypertension.
- •- Uncontrolled infection.
- •- Subjects who received any of the following within the last 14 days of
- •initiation of study treatment:
- •Major surgery (kyphoplasty is not considered major surgery), use of any
- •anti-myeloma drug therapy.
- •- Use of any investigational agents (with the exception of lenalidomide)
- •within 28 days or five half-lives (whichever is longer) of treatment.
- •- Incidence of gastrointestinal disease that may significantly alter the
- •absorption of pomalidomide.
- •- Subjects unable or unwilling to undergo antithrombotic prophylactic
- •- Any serious medical condition, laboratory abnormality, or psychiatric
- •illness that would prevent the subjects from signing the informed
- •consent form.
- •- Pregnant or breastfeeding females.
- •- Known human immunodeficiency virus (HIV) positivity, active
- •infectious hepatitis A, B or C or chronic hepatitis B or C.
- •- Pre-existing pulmonary, cardiac or renal impairement that prevents
- •hydration measures as described at section 9.5.
- 另有 2 项未显示
研究者
相似试验
进行中（未招募）
1 期
Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) for induction and consolidation followed by Pomalidomide combined with Dexamethason vs Pomalidomide maintenance for patients with Multiple Myeloma in progression after prior 1st line treatment with Lenalidomide and Bortezomib.Multiple MyelomaEUCTR2013-003265-34-ITHOVO222
招募中
不适用
Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) forinduction and consolidation followed by Pomalidomide combined withDexamethason vs Pomalidomide maintenance for patients with MultipleMyeloma in progression after prior 1st line treatment with Lenalidomideand Bortezomib.Multiple MyelomaMultiple Myeloomziekte van KahlerNL-OMON24039Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON)222
进行中（未招募）
1 期
Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) for induction and consolidation followed by Pomalidomide combined with Dexamethason vs Pomalidomide maintenance for patients with Multiple Myeloma in progression after prior 1st line treatment with Lenalidomide and Bortezomib.MedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864Multiple MyelomaEUCTR2013-003265-34-ATHOVON Foundation111
进行中（未招募）
1 期
Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) for induction and consolidation followed by Pomalidomide combined with Dexamethason vs Pomalidomide maintenance for patients with Multiple Myeloma in progression after prior 1st line treatment with Lenalidomide and Bortezomib.Multiple MyelomaEUCTR2013-003265-34-NLHOVON Foundation222
招募中
2 期
Pomalidomide combined with Carfilzomib and Dexamethasone (PCd) for induction and consolidation followed by Pomalidomide combined with Dexamethason vs Pomalidomide maintenance for patients with Multiple Myeloma in first relapse after prior 1st line treatment with Lenalidomide and Bortezomib.10018865Multiple MyelomaNL-OMON53109HOVO52