EUCTR2009-012136-33-FR进行中（未招募）1 期
Open randomised phase II study evaluating the anti-tumour activity, safety and pharmacology of two different dose regimens of IPH 2101, a human monoclonal anti-KIR antibody, in patients with multiple myeloma in stable partial response after a first line therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
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) MM which initially required a systemic therapy and received a first line treatment, conventional doses of chemotherapies or high dose chemotherapy and an autologous transplantation of hematopoietic cells, followed or not by a consolidation treatment.
- •2) Residual disease considered as evaluable with:
- •- Quantifiable serum M-protein
- •3) Responses which are partial (PR and VGPR) and in plateau
- •- Partial response should meet the IMWG uniform response criteria: a = 50% reduction from value of serum M-protein before the first line chemotherapy treatment and a reduction in 24h urinary M protein by = 90% or to < 200 mg / 24h;
- •- Very good partial response according to the IMWG uniform response criteria with 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg/24h; Furthermore the M protein should spike in the gamma globulin area;
- •- Plateau phase is defined by stable levels of M protein in serum checked 4 weeks apart on at least 3 consecutive samples.
- •Fluctuations ± 1 week in sampling and ± 5 % in M protein levels are allowed.
- •4) ECOG performance status of 0, 1 or 2
- •5) Clinical laboratory values at screening:
- •- Calculated creatinine clearance (according to MDRD) > 50 ml/min
- •- Platelet > 50 x 109 /l
- •- ANC > 1 x 109 /l
- •- Bilirubin levels < 1.5 ULN ; ALT and AST < 2.5 ULN (grade 1 NCI)
- •6) Male or female patient who accepts and is able to use recognised effective contraception (oral contraceptives, IUCD, barrier method of contraception in conjunction with spermicidal jelly) throughout the study.
- •7) Signed inform consent obtained before any trial-related activities
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Age < 18 years old or > 75 years old
- •2) Previous consolidation/ maintenance therapy by Imid (thalidomide, lenalidomid) or bortezomib within the last 2 months
- •3) Treatment with chemotherapy, systemic corticosteroid within the previous 2 months
- •4) Treatment with growth factors (EPO, G- or GM-CSF) within the previous 1 month
- •5) MM in VGPR with a monoclonal spike in the beta globulin area
- •6) Radiotherapy for bone or visceral lesion within the last 3 months
- •7) Use of any investigational agent within the last 2 months
- •8) Primary or associated amyloidosis
- •9) Peripheral neuropathy of grade = III according to the CTCAE of the NCI
- •10) Abnormal cardiac status with any of the following
- •a) NYHA stage III or IV congestive heart failure
- •b) myocardial infarction within the previous 6 months
- •c) symptomatic cardiac arrhythmia despite treatment
- •11) Current active infectious disease or positive serology for HIV, HCV or positive Hbs Antigen
- •12) History of or current auto-immune disease
- •13) Serious concurrent uncontrolled medical disorder
- •14) History of other malignancy (apart from basal cell carcinoma of the skin, or in situ cervix carcinoma)
- •15) History of allogenic hematopoietic cell or solid organ transplantation
- •16) Pregnant or lactating women
- •17) Any medical condition which is regarded by the investigator as incompatible with the study participation
- •18) Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
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