NCT01324947已完成3 期
Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 74
- 试验地点
- 91
- 主要终点
- Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.
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
- •Subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in Study CC-4047-MM-003 and discontinued study therapy with dexamethasone alone (Treatment Arm B) after at least starting the second cycle of dexamethasone treatment and due to development of documented disease progression according to the International Myeloma Working Group (IMWG) criteria and as decided by an Independent Review Adjudication Committee (IRAC).
- •Must be ≥ 18 years at the time of signing the informed consent form.
- •The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. The only exception is if a skeletal survey was performed within 90 days prior to the start of Cycle 1, then a new survey will not be required.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5g/dL or urine M-protein ≥ 200 mg/24 hours).
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or
- •Females of childbearing potential (FCBP†) must agree to utilize two reliable forms of contraception simultaneously or practice true abstinence [when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception]from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe.
- •Females must agree to abstain from breastfeeding during study participation and 28 days after study discontinuation.
- •Males must agree to either use a latex condom during any sexual contact with FCBP or practice true abstinence [when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception] while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. .
- •Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study treatment.
- •All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
- •All subjects must agree not to share study medication
- •Exclusion Criteria
- •The presence of any of the following will exclude a subject from enrollment:
- •Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (Arm B).
- •Subjects who received any anti-myeloma or anti-cancer therapies within the last 14 days of wash-out period before initiation of study treatment.
- •Subjects who discontinued CC-4047-MM-003 study ≥120 days.
- •Subjects who initiate another anti-myeloma therapy from the time of disease progression on study CC-4047-MM-003 to the time of treatment initiation in the companion study.
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) < 1,000/µL.
- •Platelet count < 75,000/µL for subjects in whom < 50% of bone marrow nucleated cells are plasma cells; or a platelet count < 30,000/µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells
- •Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula (If creatinine clearance calculated from the 24-hour urine sample is ≥45 ml/min, patient will qualify for the trial)
- •Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L);
- •Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
- •Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
- •Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinaemia
- •Prior history of malignancies, other than Multiple Myeloma (MM), unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following:
- •Basal or Squamous cell carcinoma of the skin
- •Carcinoma in situ of the cervix or breast
- •Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
- •Hypersensitivity to thalidomide or lenalidomide. (This includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).
- •Peripheral neuropathy ≥ Grade
- •Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
- •Subjects who are planning for or who are eligible for stem cell transplant.
- •Subjects with any one of the following:
- •Congestive heart failure (NY Heart Association Class III or IV)
- •Myocardial infarction within 12 months prior to starting study treatment
- •Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
- •Subjects who received any of the following within the last 14 days of initiation of study treatment:
- •Plasmapheresis
- •Major surgery (kyphoplasty is not considered major surgery)
- •Radiation therapy
- •Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.
- •Subjects with chronic conditions such as rheumatoid arthritis, multiple sclerosis and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
- •Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
- •Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
- •Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or breastfeeding females.
- •Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B or C.
排除标准
- 未提供
研究组 & 干预措施
Pomalidomide
Experimental
Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity
干预措施: pomalidomide (Drug)
结局指标
主要结局
Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment
时间窗: From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level \<100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to \<200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.
次要结局
- Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment(From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.)
- Number of Participants With Adverse Events and Type of Adverse Events(From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.)
- Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG(From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.)
- Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria(From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.)
- Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria(From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.)
- Kaplan-Meier Estimate for Overall Survival(From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.)
- Time to Response Based on IMWG and Assessed by the Investigator(From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks)
研究者
研究点 (91)
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