EUCTR2017-000169-60-NL进行中（未招募）1 期
A phase 2 study of nivolumab combined with daratumumab with or without low dose cyclophosphamide in relapsed/refractory multiple myeloma - NIVO/DARA study
VU University Medical Center0 个研究点目标入组 60 人开始时间: 2017年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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. Age >=18 years
- •2. Subject must have documented multiple myeloma as defined by the criteria below:
- •- Monoclonal plasma cells in the bone marrow =10% at some point in their disease history or presence of a biopsy proven plasmacytoma.
- •- Measurable disease as defined by any of the following:
- •- Serum monoclonal paraprotein (M-protein) level =5 g/L (0.5 g/dL); or urine M-protein level =200 mg/24 hours; or serum immunoglobulin free light chain =100 mg/L (10 mg/dL) and abnormal serum immunoglobulin kappa lambda free light chain ratio (See Appendix A)
- •3. Relapsed or refractory disease. Relapse is defined as progression of disease after an initial response to previous treatment, more than 60 days after cessation of treatment. Refractory disease is defined as <25% reduction in M-protein or progression of disease during treatment or within 60 days after cessation of treatment.
- •4. Subject had at least 2 prior anti-myeloma regimens.
- •(Note: Induction, bone marrow transplant with or without maintenance therapy is
- •considered one regimen.)
- •5. Subject has developed lenalidomide-refractory disease during prior treatment with a lenalidomide-containing regimen
- •Refractory disease is defined as <25% reduction in M-protein or progression of disease
- •during treatment or within 60 days after cessation of treatment.
- •6. Subject received prior treatment with a proteasome inhibitor-containing regimen for at
- •least 2 consecutive cycles.
- •7. WHO performance 0, 1, or 2
- •8. Life expectancy at least 3 months
- •9. Written informed consent
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. Prior therapy with daratumumab or other anti-CD38 therapies
- •2. Non-secretory myeloma
- •3. Systemic AL amyloidosis or plasma cell leukemia (>2.0x109/L circulating plasma cells by standard differential) or Waldenstrom’s macroglobulinemia
- •4. Subject has known meningeal involvement of multiple myeloma
- •5. Subject has received anti-myeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, before start of treatment. This included subjects who have received a cumulative dose of corticosteroid greater than or equal to the equivalence of 140 mg prednisone or a single dose of corticosteroid greater than or equal to the equivalence of 40 mg/day dexamethasone within the 2-week period before start of treatment.
- •6. Prior treatment with an anti-PD1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
- •7. Subject has previously received an allogeneic stem cell transplantation (at any time)
- •8. Inadequate marrow reserve as defined by a platelet count <75 x 109/L (<50 x 109/L if =50% of bone marrow mononucleated cells are plasma cells) or an absolute neutrophil count <1.0 x 109/L
- •9. a) Subject has known chronic obstructive pulmonary disease (COPD) with an Forced Expiratory Volume in 1 second (FEV1) < 50% of predicted normal. Note that FEV1 testing is required for patients suspected of having COPD and subjects must be excluded if FEV1 <50% of predicted normal.
- •b) Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification. (Note that subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed in the study).
- •10. Subject has clinically significant cardiac disease
- •11. Significant hepatic dysfunction (total bilirubin ? 1.5 times normal value (except subjects with Gilbert syndrome, who can have total bilirubin <3.0 mg/dL) or transaminases ? 3 times normal value), unless related to myeloma
- •12. Creatinine clearance <30 ml/min.
- •13. Known hypersensitivity to components of the investigational products or severe allergic or anaphylactic reactions to humanized products.
- •14. Subject has any concurrent severe and/or uncontrolled medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study.
- •15. Subject is known to be seropositive for HIV or known to have AIDS, or any positive test for hepatitis B or hepatitis C indicating acute or chronic infection.
- •16. History of active malignancy during the past 3 years, except squamous cell and basal cell carcinomas of the skin and carcinoma in situ of the cervix or breast and incidental histologic finding of prostate cancer or prostate cancer that is curative, or malignancy that in the opinion of the local investigator, with concurrence with the principal investigator, is considered cured with minimal risk of recurrence within 3 years.
- •17. Subjects with active interstitial pneumonitis
- •18. Subjects with active, known or suspected autoimmune disease or inflammatory disorder. Subjects with vitiligo,
- •type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only
- •requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions
- •not expected to recur in the absence of an external trigger are permitted to enroll.
- •19. Subjects with a condition (other than MM) requiring
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