临床试验/NCT03333746

NCT03333746终止2 期

Phase II Study of Lenalidomide in Combination With Nivolumab In Patients With Relapsed/Refractory Multiple Myeloma

Yvonne Efebera1 个研究点分布在 1 个国家目标入组 1 人开始时间: 2018年3月21日最近更新: 2019年5月30日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方
入组人数: 1
试验地点: 1
主要终点: ORR (Overall Response Rate)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This phase II trial studies how well lenalidomide and nivolumab work in treating patients with multiple myeloma that has come back or does not respond to treatment. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as nivolumab, may interfere with the ability of cancer cells to grow and spread. Giving lenalidomide and nivolumab may work better in treating patients with multiple myeloma.

详细描述

PRIMARY OBJECTIVES:

I. To determine the efficacy of nivolumab in combination with lenalidomide (Revlimid) in terms of overall response rate in patients with relapse/refractory multiple myeloma (MM).

OUTLINE:

Patients receive lenalidomide orally (PO) on days 1-21 and nivolumab intravenously (IV) over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients with evidence of relapse or refractory disease as defined by International Myeloma Working Group (IMWG) criteria and measurable disease as defined by any of the following:
•Serum m-protein >= 0.5 g/dl (>= 10 g/l)
•Urine monoclonal protein >= 200 mg/24 hour(h)
•Involved free light chain (FLC) level >= 10mg/dl (>= 100mg/l) and an abnormal serum free light chain ratio (< 0.26, or > 1.65)
•Measurable biopsy proven plasmacytoma (should be measured within 28 days of initial investigational agent dosing)
•Patients must have had at least 2 prior line of therapy
•Patients must not have had progression of disease on lenalidomide 25 mg; stable disease on lenalidomide is permitted
•Patient may be enrolled at any time from last line of therapy
•Patients must have absolute neutrophil count (ANC) > 1000/uL
•Platelets >= 75,000/uL, if plasma cell percentage on bone marrow biopsy aspirate or core is > 30%, platelet eligibility requirement will be adjusted to 60,000/ul
•Total bilirubin =< 1.5 mg/dL
•Alkaline phosphatase =< 3 X the upper limit of normal (ULN)
•Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2 X the ULN
•Patients must have adequate renal function as evidenced by serum creatinine =< 2 mg/dL or calculated creatinine clearance of >= 40 ml/min within 14 days of registration using Modification of Diet in Renal Disease (MDRD) formula
•Patient must be able to swallow capsule or tablet
•Patients must provide informed consent
•Patients must have a left ventricular ejection fraction > 30%, no uncontrolled arrhythmias or New York Heart Association class III-IV heart failure
•Patients must have a Karnofsky performance status >= 70
•A negative pregnancy test will be required for all women of child bearing potential; breast feeding is not permitted
•Fertility requirements
•Female patients with child bearing potential must have a negative pregnancy test at least 7 days before starting treatment drugs
•Male patients must agree to use an adequate method of contraception for the duration of the study and for 7 months afterwards
•Female patients must be either posy-menopausal, free from menses >= 2 years (yrs), surgically sterilized, willing to use two adequate barrier methods of contraception to prevent pregnancy, or agree to abstain from sexual activity starting from screening and for 5 months afterwards
•Female patients of child bearing potential must agree to comply with the fertility and pregnancy test requirements dictated by the Rev-Assist program

排除标准

•Patients with peripheral neuropathy > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
•Patients receiving concurrent corticosteroids at the time protocol therapy is initiated other than for physiologic maintenance treatment
•History of allergic reaction (including erythema nodosum) to lenalidomide
•Concurrent use of complementary or alternative medicines that would confound the interpretation of toxicities and antitumor activity of the study drugs
•Patients with contraindication to thromboprophylaxis
•Unacceptable cardiac risk factors defined by any of the following criteria: patients with congenital long QT syndrome, any history of ventricular fibrillation or torsade de pointes, bradycardia defined as heart rate (HR) < 50 bpm, left ventricular ejection fraction < 30%
•Patients who have received targeted or investigational agents within 2 weeks or within 5 half-lives of the agent and active metabolites (whichever is longer) and who have not recovered from side effects of those therapies
•Patients who have undergone major surgery =< 2 weeks prior to starting study drug or who have not recovered from the side-effects of surgery
•Patients with known positivity for human immunodeficiency virus (HIV), or hepatitis C; baseline testing for HIV and hepatitis C is not required
•Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention, other than non-melanoma skin cancer and carcinoma in situ of the cervix should not be enrolled; patients are not considered to have a ?currently active? malignancy if they have completed therapy for a prior malignancy, are disease free from a prior malignancy for >= 5 yrs and are considered by their physician to be less than 30% risk of relapse
•Patients with active (untreated or relapsed) central nervous system (CNS) metastasis of the patient?s myeloma
•Patients with a history of gastrointestinal surgery or other procedure that might, in the opinion of the investigator(s), interfere with the absorption or swallowing of the study drugs
•Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to them by the study staff
•Any other medical condition, including mental illness or substance abuse, deemed by the investigator(s) to likely interfere with the patient?s ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

研究组 & 干预措施

Treatment (lenalidomide, nivolumab)

Experimental

Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: Laboratory Biomarker Analysis (Other)

Treatment (lenalidomide, nivolumab)

Experimental

Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: Lenalidomide (Drug)

Treatment (lenalidomide, nivolumab)

Experimental

Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: Nivolumab (Biological)

Treatment (lenalidomide, nivolumab)

Experimental

Patients receive lenalidomide PO on days 1-21 and nivolumab IV over 1 hour on days 1 and 14. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

干预措施: Pharmacological Study (Other)

结局指标

主要结局

ORR (Overall Response Rate)

时间窗: Up to 12 months

Will be assessed by IMWG response criteria. 95% binomial confidence intervals will also be calculated for the estimate of the proportion of responses.

次要结局

Overall Survival (OS)(Up to 3 years)
Progression Free Survival (PFS)(Time from study entry until disease progression or death at trial closure for the per protocol population, assessed up to 3 years)
Time to Progression (TTP)(Time from start of treatment until the date he or she has progression or dies, assessed up to 3 years)

研究者

发起方

Yvonne Efebera

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Yvonne Efebera

Principal Investigator

Ohio State University Comprehensive Cancer Center

研究点 (1)

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