EUCTR2018-000665-36-NL进行中（未招募）1 期
A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2) - A.R.R.O.W.2
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
- Amgen Inc
- 入组人数
- 460
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
- •*Subject has provided informed consent prior to initiation of any study-specific activities or procedures or subject’s legally acceptable representative has provided informed consent prior to any study-specific activities/procedures being initiated when the subject has any kind of condition that, in the opinion of the Investigator, may compromise the ability of the subject to give written informed consent.
- •*Males or females = 18 years of age.
- •*Documented relapse or progressive multiple myeloma after last treatment Subjects refractory to the most recent line of therapy are eligible, unless last treatment contained PI or lenalidomide and dexamethasone).
- •*Subjects must have at least PR to at least 1 line of prior therapy.
- •*Subjects must have received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation maintenance therapy will be considered as 1 line of therapy). See Section 12.8 for guidelines for documenting prior treatment.
- •* Prior therapy with a PI is allowed if the patient achieved at least a PR to the most recent therapy with a PI, did not relapse within 60 days of discontinuation, and PI was no removed due to toxicity
- •* Prior therapy with a lenalidomide and dexamethasone is allowed if the patient achieved at least a PR to the most recent therapy with lenalidomide and dexamethasone, did not progress within 3 months of a lenalidomide and dexamethasone-containing treatment, did not relapse within 60 days of discontinuation of treatment, and treatment was no removed due to toxicity
- •History of prior neuropathy is permitted if not exceeding grade 2 which has either resolved within 14 days of enrollment or if ongoing is = grade 1),
- •Patients are permitted to have received single agent
- •lenalidomide as maintenance therapy during the 6-months prior to first study
- •* Measurable disease with at least 1 of the following assessed within 28 days prior to randomization:
- •IgG multiple myeloma: serum monoclonal protein (M-protein) level = 1.0 g/dL
- •IgA, IgD, IgE multiple myeloma: serum M-protein level = 0.5 g/dL
- •urine M-protein = 200 mg per 24 hours
- •in subjects without measurable serum or urine M-protein, serum-free light
- •chain (SFLC) = 100 mg/L (involved light chain) and an abnormal serum
- •kappa lambda ratio
- •*Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 = 2 (see Section 12.9).
- •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 230
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 230
排除标准
- •Disease-related
- •*Waldenström macroglobulinemia.
- •*Multiple myeloma of IgM subtype.
- •*POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal
- •protein, and skin changes).
- •*Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard
- •differential).
- •*Primary amyloidosis (patients with multiple myeloma with asymptomatic
- •deposition of amyloid plaques found on biopsy would be eligible if all other
- •criteria are met).
- •*Myelodysplastic syndrome.
- •Other Medical Conditions
- •*History of other malignancy within the past 5 years, with the following exceptions:
- •Malignancy treated with curative intent and with no known active disease
- •present for = 3 years before enrollment and felt to be at low risk for
- •recurrence by the treating physician
- •Adequately treated non-melanoma skin cancer or lentigo maligna without
- •evidence of disease
- •Adequately treated cervical carcinoma in situ without evidence of disease
- •Adequately treated breast ductal carcinoma in situ without evidence of
- •Prostatic intraepithelial neoplasia without evidence of prostate cancer
- •Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in
- •Treated medullary or papillary thyroid cancer
- •Similar neoplastic conditions with an expectation of > 95% 5-year
- •disease-free survival
- •* Known HIV infection, hepatitis C infection (subjects with hepatitis C that achieve
- •a sustained virologic response after antiviral therapy are allowed), or hepatitis B
- •infection (subjects with hepatitis B surface antigen or core antibody that achieve
- •sustained virologic response with antiviral therapy are permitted with a
- •requirement for regular monitoring for reactivation for the duration of
- •treatment on the study).
- •*Ongoing graft-vs-host disease.
- •*Acute active infection requiring systemic antibiotics, antifungal, antiviral (except
- •antiviral therapy directed at hepatitis B) agents within 14 days prior to
- •randomization.
- •*Known cirrhosis.
- •*Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior
- •to randomization.
- •*Subjects with pleural effusions requiring thoracentesis or ascites requiring
- •paracentesis within 14 days prior to randomization.
- •Cardiopulmonary Conditions
- •* Uncontrolled hypertension, defined as subject whose blood pressure exceeds = 160 mmHG - systolic or = 100mmHg diastolic when taken in accordance with the European Society of hypertensions/European Society of cardiology 2018 guidelines. (Section 12.10; Williams et al, 2018).
- •*Active congestive heart failure (New York Heart Association Class III to IV),
- •symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected
- •QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction
- •within 4 months prior to randomization.
- •*Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
- •*History of interstitial lung disease or ongoing interstitial lung disease.
- •Prior/Concomitant Therapy
- •*Immunotherapy within 28 days prior to randomization.
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