EUCTR2010-023343-16-DE进行中（未招募）不适用
Open-label, multi-center, single-arm study for the safety and efficacy of pomalidomide (CC-4047) monotherapy for subjects with refractory or relapsed and refractory multiple myeloma: a companion study for clinical trial CC-4047-MM-003 - companion study for clinical trial CC-4047-MM-003
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.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 IMWG
- •criteria and as decided by an IRAC.
- •2.Must be = 18 years at the time of signing the informed consent form.
- •3.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
- •4.Must be able to adhere to the study visit schedule and other protocol
- •requirements.
- •5.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).
- •6.Eastern Cooperative Oncology Group (ECOG) performance status score
- •of 0, 1, or 2.
- •7. 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.
- •8.Females must agree to abstain from breastfeeding during study
- •participation and 28 days after study discontinuation.
- •9. 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.
- •10.Males must also agree to refrain from donating semen or sperm while
- •on pomalidomide and for 28 days after discontinuation from this study
- •11.All subjects must agree to refrain from donating blood while on study
- •drug and for 28 days after discontinuation from this study treatment.
- •12.All subjects must agree not to share study medication.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 28
排除标准
- •1.Subjects with multiple myeloma who were not treated as a part of
- •Study CC-4047-MM-003 (Arm B).
- •2.Subjects who received anti-myeloma, or anti-cancer therapies within
- •the last 14 days of wash-out period before initiation of study treatment.
- •3.Subjects who discontinued CC-4047-MM-003 study =120 days.
- •4.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.
- •5.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
- •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
- •6.Prior history of malignancies, other than 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
- •7.Hypersensitivity to thalidomide or lenalidomide. (This includes =
- •Grade 3 rash during prior thalidomide or lenalidomide therapy).
- •8.Peripheral neuropathy = Grade 2.
- •9.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.
- •10.Subjects who are planning for or who are eligible for stem cell
- •transplant.
- •11.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
- •Unstable or poorly controlled angina pectoris, including Prinzmetal
- •variant angina pectoris
- •12.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
- •13.Use of any investigational agents within 28 days or 5 half lives
- •(whichever is longer) of treatment.
- •14.Subjects with chronic conditions such as rheumatoid arthritis,
- 另有 10 项未显示
研究者
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