NCT03218163终止2 期
A Phase II Study of MEDI-551 as Maintenance Therapy After Allogeneic Stem Cell Transplant in Patients With Newly Diagnosed Poor-risk or Relapsed Multiple Myeloma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2017年9月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
Determine the progression free survival of high-risk or relapsed Multiple Myeloma (MM) patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.
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
- •Previous diagnosis of MM based on standard criteria as defined in Appendix A (Diagnostic Criteria for MM). Diagnostic studies need not be performed within 30 days of registration;
- •Patients must meet one of the disease criteria outlined in either a, b, or c:
- •a. Patients with newly diagnosed high-risk MM achieving a partial response (PR) or better at the time of enrollment in response to systemic anti-myeloma therapy, which may include autologous hematopoietic stem cell transplant (HSCT).
- •High risk is defined by the presence of any one of the following:
- •i. High-risk chromosomal translocations by fluorescent in situ hybridization (FISH): t(4;14), t(14;16), t(14;20), del(17p), del(1p), amplification 1q ii. Myeloma Prognostic Risk Signature 70-Gene expression profiling (MyPRS GEP-70) high-risk signature either at diagnosis or at time of registration for the study iii. Lactate dehydrogenase (LDH) > 300 U/L at diagnosis iv. Plasma cell leukemia v. Relapse from prior therapy within 12 months
- •b. Patients with high-risk MM with at least 1 prior progression in PR or better in response to salvage systemic anti-myeloma therapy at the time of enrollment
- •c. Patients with standard risk MM with 1 prior progression within 18 months from an autologous HSCT and in very good partial remission (VGPR) or better in response to salvage systemic anti-myeloma therapy at the time of enrollment.
- •Patients must have a suitable first-degree or second-degree related, Human leukocyte antigen (HLA)-haploidentical or HLA-matched stem cell donor. The donor and recipient must be identical at least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, major histocompatibility complex, class II, DR beta 1 (HLA-DRB1), and Major Histocompatibility Complex, Class II, DQ Beta 1 (HLA-DQB1). A minimum match of 5/10 is therefore required, and will be considered sufficient evidence that the donor and recipient share one HLA haplotype;
- •No previous AlloSCT (syngeneic HSCT permissible);
- •Any previous autologous HSCT must have occurred at least 3 months prior to start of conditioning;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- •Life expectancy > 6 months;
- •Adequate end organ function as measured by:
- •Left ventricular ejection fraction ≥ 35% or shortening fraction > 25%
- •Bilirubin ≤ 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis), and alanine aminotransferase (ALT) and aspartate transaminase (AST) < 5x upper limit of normal (ULN)
- •Forced expiratory volume at one second (FEV1) and forced vital capacity (FVC) > 40% of predicted
- •Not pregnant or breast-feeding;
- •No uncontrolled infection. Note: Infection is permitted if there is evidence of response to medication;
- •The patient must be able to comprehend and have signed the informed consent.
排除标准
- •Diagnosis of any of the following cancers:
- •POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein (M-protein) and skin changes)
- •Non-secretory myeloma (no measurable protein on Serum Free Lite Assay)
- •HTLV1 / HTLV2 positive
- •Diagnosis of amyloidosis
- •Failed to achieve at least a partial response (PR) to latest therapy;
- •Known history of HIV infection;
- •Systemic infection requiring treatment with antibiotics, antifungal, or antiviral agents within 7 days of registration;
- •History of malignancy other than MM within 5 years of registration, except adequately treated basal or squamous cell skin cancer;
- •History of serious allergy or reaction to any component of the MEDI-551 formulation that would prevent administration;
- •Active hepatitis B as defined by seropositivity for hepatitis B surface antigen or patients with positive hepatitis B core antibody titers.
- •Patients with hepatitis C antibody will be eligible provided that they do not have elevated liver transaminases or other evidence of active hepatitis.
研究组 & 干预措施
MEDI-551 Treatment Arm
Experimental
Medi-551 maintenance therapy will be initiated on Day 60, Day 90, or Day 120 of NM-AlloSCT based on the eligibility criteria for the initiation of maintenance therapy as described in Section 3.1. MEDI-551 will be administered on 28-day cycles at a dose of 4mg/kg, as an IV infusion over 60 ±15 minutes. Infusion sets must contain a 0.2 micron in-line filter. MEDI-551 will be administered on days 1, 8, 15, and 22 of cycle 1, then 4mg/kg IV on day1 of cycles 2 through 12. Treatment may be stopped earlier if there is unacceptable toxicity, development of Grade 3 or 4 graft-versus-host disease (GVHD), documentation of disease progression, or patient withdrawal for other reasons.
干预措施: MEDI-551 Maintenance (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: 5 years
The progression free survival (PFS) of high-risk or relapsed multiple myeloma (MM) patients undergoing non-myeloablative bone marrow allogeneic transplantation (NM-AlloSCT) followed by maintenance therapy with MEDI-551.
次要结局
未报告次要终点
研究者
研究点 (1)
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