EUCTR2017-002611-34-FR进行中（未招募）1 期
A Randomized, Open-label, Multicenter, Multiphase Study of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, Administered in Combination with Daratumumab, Compared with Daratumumab Alone in Subjects with Relapsed or Refractory Multiple Myeloma.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 386
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
- •Each potential subject must satisfy all of the following criteria to be enrolled in the study.
- •1. At least 18 years of age.
- •2. Have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) in any order during the course of treatment for multiple myeloma or have disease that is refractory to both a PI and an IMiD. (For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one.Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one).
- •3. Evidence of a response to at least 1 prior treatment regimen.
- •4. Documented measurable disease for multiple myeloma at screening as defined by the criteria below:
- •-IgG multiple myeloma: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours; or
- •-IgA, IgM, IgD, or IgE multiple myeloma: serum M-protein level =0.5 g/dL or urine M-protein level =200 mg/24 hours; or
- •-Light chain multiple myeloma without measurable disease in the serum or urine: Serum immunoglobulin free light chain =10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
- •5. Have relapsed or refractory disease at time of enrollment as defined below:
- •Relapsed disease is defined as an initial response to previous treatment, followed by progressive disease (PD) by International Myeloma Working Group (IMWG) criteria >60 days after cessation of treatment.
- •Refractory disease is defined as <25% reduction in M-protein or PD by IMWG criteria during previous treatment or =60 days after cessation of treatment.
- •6. Eastern Cooperative Oncology Group Performance Status (ECOG)performance status score of 0, 1, or 2.
- •7. Adequate organ function (bone marrow, liver, renal)
- •8. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •9. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •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 154
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 232
排除标准
- •Any potential subject who meets any of the following criteria will be excluded from the study:
- •1. Received any of Anti-CD38 antibody, including daratumumab or Anti-PD-1 and anti-PD-L1 antibodies in the past.
- •2. Clinically significant cardiac or pulmonary disease.
- •3. Prior diagnosis of autoimmune disease with the exception of subjects:
- •- With autoimmune thyroid disease or type 1 diabetes that is well controlled on a stable medication regimen
- •- With vitiligo, alopecia, or resolved childhood asthma/atopy
- •- With psoriasis not requiring systemic therapy
- •- With transient autoimmune manifestations of an acute infectious disease that resolved upon treatment of the infectious agent.
- •3. Unresolved Grade 2 or higher toxicity effects from previous treatment with immunotherapy not recovered to Grade =1 or baseline
- •4. Received any of the following prescribed medications or therapies within the specified period:
- •- Antimyeloma treatment within 2 weeks or 5 pharmacokinetic half-lives of the treatment, whichever is longer, prior to first administration of study drug. The only exception is emergency use of a short course of corticosteroids (equivalent of dexamethasone 40 mg/day for a maximum of 4 days) for palliative treatment prior to first administration of study drug.
- •- An allogenic stem cell transplant (SCT) at any time; or autologous SCT within 12 weeks prior to first administration of study drug.
- •- Other investigational agent (including investigational vaccines), participation in another clinical study with therapeutic intent, or used an invasive investigational medical device within 28 days or 5 pharmacokinetic half-lives of the investigational agent (whichever is longer) prior to first administration of study drug.
- •- Systemic radiotherapy within 14 days prior to first administration of study drug.
- •5. Plans to undergo a stem cell transplant prior to progression of disease on this study.
- •6. History of malignancy (other than multiple myeloma) within 2 years prior to first administration of study drug
- •7. Known or suspected of not being able to comply with the study protocol.
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