NCT00698776已完成1 期
Phase I/II Trial of Combination of Lenalidomide (Revlimid, LEN) and Autologous Mature Dendritic Cells Pulsed With α-galactosyl Ceramide (α-GalCer; KRN7000) in Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of Dose Limiting Toxicities (DLTs)
研究概览
简要总结
This is a single arm open label trial to test the tolerability of the combination of monocyte derived DCs loaded with KRN7000 (DC-KRN7000) and Lenalidomide (LEN) in patients with asymptomatic myeloma. Phase I component of the study will evaluate the optimal dose of LEN, with particular emphasis on safety. After an interim analysis of these data, a single dose level will be chosen for phase II component in additional patients.
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
- •Previously untreated asymptomatic multiple myeloma
- •Prior therapy: Patients cannot have received prior thalidomide, lenalidomide or corticosteroids for the intent of treating their myeloma. Prior corticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use should be restricted to the equivalent of prednisone 10 mg per day or less. Prior radiation therapy for the treatment of solitary plasmacytoma is permitted, but more than 3 months should have elapsed from the last day of radiation.
- •Measurable disease as defined by one of the following:
- •Serum monoclonal protein ≥1.0 g by protein electrophoresis
- •>200 mg of monoclonal protein in the urine on 24 hour electrophoresis
- •Measurable soft tissue plasmacytoma.
- •≥10% plasma cells as measured on the bone marrow aspirate or bone marrow biopsy.
- •Age ≥18 years.
- •ECOG Performance status 0, 1, or
- •Willing to provide written informed consent.
- •All study participants must be registered into the mandatory RevAssistSM program, and be willing and able to comply with the requirements of RevAssistSM.
- •Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to and again within 24 hours of prescribing lenalidomide (prescriptions must be filled within 7 days) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. See Appendix: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.
- •Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin).
- •(b) Laboratory inclusion criteria obtained ≤ 1 month prior to registration:
- •ANC ≥1500/μL
- •PLT ≥100,000/μL
- •Hemoglobin ≥8.0 g/dl
- •Creatinine ≤2.0 mg/dL (Any elevation above normal range should not be felt to be related to myeloma)
排除标准
- •Solitary plasmacytoma.
- •Uncontrolled infection.
- •Another active malignancy.
- •Immediate need for chemotherapy in the opinion of the treating physician.
- •New York Heart Association classification III or IV.
- •Existing ≥Grade 2 neuropathy.
- •Any of the following:
- •Pregnant women
- •Nursing women
- •This study involves an agent that has known genotoxic, mutagenic and teratogenic effects. Men or women of childbearing potential who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], or abstinence, etc.)
- •Active systemic autoimmunity (e.g. systemic lupus erythematosus
研究组 & 干预措施
Active
Experimental
10 mg/day in cohort 1, and 25 mg/day in cohort 2. LEN is administered orally in standard 21 day cycles starting one week before each DC injection and ending 14 days after each DC injection. All patients will receive a total of three cycles of LEN.
干预措施: Lenalidomide (Drug)
Active
Experimental
10 mg/day in cohort 1, and 25 mg/day in cohort 2. LEN is administered orally in standard 21 day cycles starting one week before each DC injection and ending 14 days after each DC injection. All patients will receive a total of three cycles of LEN.
干预措施: Monocyte derived DCs loaded with KRN7000 (Biological)
结局指标
主要结局
Number of Dose Limiting Toxicities (DLTs)
时间窗: upon completion of treatment
次要结局
- Number of Natural Killer Cells(NKT)that make IFNγ in Vitro(upon completion of treatment)
研究者
研究点 (1)
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