KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 53
- 试验地点
- 4
- 主要终点
- PET negativity after induction
研究概览
简要总结
A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.
详细描述
Patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (VGPR). Eligible performed regimens are defined in the protocol. All patients will perform a PET-CT, and PET-negative patients will be excluded from protocol treatment. The PET-positive patients will do a minimal residual disease (MRD-)evaluation in the bone marrow before entering treatment. After 4 28day cycles of Carfilzomib-Revlimid-Dexamethason, a new MRD and a new PET-CT will be performed, as measures of outcome. Patients will continue treatment as written in the protocol.
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
- •Prior confirmed diagnosis of multiple myeloma (2014).
- •Received standard first line treatment with at least partial response. Standard first line treatment is defined as
- •VRD, VTD or VCD followed by ASCT, or
- •MPV at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or
- •Rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles.
- •Carfilzomib naïve.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count >35 x 109/L.
- •At least very good partial remission (VGPR) from first line treatment
排除标准
- •Change of first line treatment because of stabile or progressive disease.
- •Major surgery within 28 days before enrollment.
- •Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
- •Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
- •Central nervous system involvement.
- •Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
- •Uncontrolled hypertension or uncontrolled diabetes despite medication
- •Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
- •Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- •Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
研究组 & 干预措施
PET-CT-positive patients
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
干预措施: Carfilzomib (Drug)
PET-CT-positive patients
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
干预措施: Lenalidomide (Drug)
PET-CT-positive patients
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
干预措施: PET-CT (Device)
PET-CT-positive patients
Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles
干预措施: Dexamethasone (Drug)
结局指标
主要结局
PET negativity after induction
时间窗: 1 month after induction
How many of PET positive patients will become PET negative after treatment
次要结局
- PET correlation with MRD Euroflow(1 month after induction)
研究者
Fredrik Hellem Schjesvold
Head of Oslo Myeloma Center
Oslo University Hospital