A Phase III Randomized, Double-Blind Study of Maintenance Therapy With CC-5013 (NSC # 703813) or Placebo Following Autologous Stem Cell Transplantation for Multiple Myeloma
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 460
- 试验地点
- 221
- 主要终点
- Time to Progression
研究概览
简要总结
This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.
详细描述
PRIMARY OBJECTIVE:
I. To determine the efficacy of CC-5013 (lenalidomide) in prolonging time to disease progression in patients with multiple myeloma after autologous stem cell transplant (ASCT).
SECONDARY OBJECTIVES:
I. To determine if CC-5013 will increase the complete response (CR) rate in patients with multiple myeloma following ASCT.
II. To compare the progression-free survival (PFS) and overall survival (OS) in patients with multiple myeloma who have undergone ASCT and who then are randomized to either CC-5013 or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have active multiple myeloma requiring treatment (Durie-Salmon stage >= 1) and have stable disease or be responsive to at least 2 months of any induction therapy; patients with smoldering myeloma are not eligible unless the disease has progressed to >= stage 1
- •No more than 12 months of any prior therapy, including CC-5013 and thalidomide
- •Within 12 months of initiation of induction therapy
- •No prior progression after initial therapy; in addition, no more than two regimens will be allowed excluding dexamethasone alone
- •No prior peripheral blood, bone marrow, or solid organ transplant
- •Patients must have peripheral blood stem cell collection of >= 2 x 10^6 cluster of differentiation (CD)34+ cells/kg (patient body weight) and preferably 5 x 10^6 cells/kg (patient body weight); stem cells may be collected at any time prior to transplant; peripheral blood stem cell collection may occur before or after registration
- •Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Patients must have diffusing capacity of the lung for carbon monoxide (DLCO) > 50% predicted with no symptomatic pulmonary disease
- •Patients must have left ventricular ejection fraction (LVEF) >= 40% by multi gated acquisition scan (MUGA) or echocardiogram
- •Patients must not have uncontrolled diabetes mellitus
- •Patients must not have an active serious infection
- •Patients must not be human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSag), or hepatitis (Hep) C positive
- •Patients must be non-pregnant and non-nursing; women of childbearing potential must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL 10-14 days prior to registration and repeated within 24 hours prior to the first dose of lenalidomide; in addition, women of childbearing potential taking lenalidomide must have a pregnancy test performed by the doctor weekly during the first 4 weeks of treatment, and then every 4 weeks if menses are regular and every 2 weeks if menses are irregular, and then 30 days following the last dose of lenalidomide; women of childbearing potential must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control - one highly effective method (intrauterine device [IUD], hormonal, tubal ligation, or partner's vasectomy), and one additional effective method (latex condom, diaphragm, or cervical cap) - at the same time, at least 4 weeks before she begins lenalidomide therapy; "women of childbearing" potential is defined as a sexually mature woman who has not undergone a hysterectomy or who has had menses at any time in the preceding 24 consecutive months; men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking lenalidomide and for 4 weeks after therapy is stopped, even if they have undergone a successful vasectomy
- •Absolute neutrophil count (ANC) >= 1000/uL
- •Platelets >= 100,000/uL
- •Creatinine clearance* >= 40 cc/min
- •To be calculated by method of Cockcroft-Gault or after 24-hour urine collection
- •Creatinine =< 2 mg/dL
- •Total bilirubin =< 2 mg/dL
- •Aspartate aminotransferase (AST) =< 3 x upper limits of normal
- •Alkaline phosphatase =< 3 x upper limits of normal
- •Urine (U)-human chorionic gonadotropin (HCG) or serum HCG negative (if patient of childbearing potential)
排除标准
- 未提供
研究组 & 干预措施
Arm II (melphalan, autologous PBSCT, placebo)
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo Administration (Other)
Arm II (melphalan, autologous PBSCT, placebo)
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Arm I (melphalan, autologous PBSCT, lenalidomide)
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Arm I (melphalan, autologous PBSCT, lenalidomide)
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm I (melphalan, autologous PBSCT, lenalidomide)
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Peripheral Blood Stem Cell Transplantation (Procedure)
Arm II (melphalan, autologous PBSCT, placebo)
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Arm II (melphalan, autologous PBSCT, placebo)
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Peripheral Blood Stem Cell Transplantation (Procedure)
Arm I (melphalan, autologous PBSCT, lenalidomide)
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Lenalidomide (Drug)
Arm I (melphalan, autologous PBSCT, lenalidomide)
Beginning between day 100-110, patients receive lenalidomide PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Melphalan (Drug)
Arm II (melphalan, autologous PBSCT, placebo)
Beginning between day 100-110, patients receive placebo PO once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Melphalan (Drug)
结局指标
主要结局
Time to Progression
时间窗: Duration of study (up to 10years)
Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method. Progression was defined per the International Myeloma Working Group definition as one more of the following: * 25% increase in serum M-component (absolute increase \>= 0.5g/dl) * 25% increase in urine M-component (absolute increase \>= 200mg/24hour * 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase \>= 10mg/dl) * 25 % increase in bone marrow plasma cell percentage (absolute increase of \>=10%) * Definite development of new bone lesion or soft tissue plasmacytomas * Development of hypercalcemia
次要结局
- Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100(Day 100)