EUCTR2015-004831-11-ES进行中（未招募）1 期
A Phase 1/2, multicenter, open-label study to determine the recommended dose and regimen of durvalumab (MEDI4736) in combination with lenalidomide (LEN) with and without dexamethasone (dex) in subjects with newly diagnosed multiple myeloma (NDMM).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 138
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. Subject is ? 18 years of age at the time of signing the informed consent form (ICF)
- •2. Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted
- •3. Subject is willing and able to adhere to the study visit schedule and other protocol requirements
- •4. Subject must have documented diagnosis with previously untreated (for cohort C, the induction and consolidation treatment along with the first ASCT are allowed), symptomatic multiple myeloma (MM) as defined in the protocol
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •6. Females of childbearing potential (FCBP) must:
- •a. Have two negative pregnancy tests as verified by the investigator prior to starting study treatment. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
- •b. She must either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and be source documented) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study treatment, during the study therapy (including dose interruptions), and for 90 days after discontinuation of study treatment.
- •c. Refrain from egg cell and blood donation for 90 days after the final dose of durvalumab.
- •7. Male subjects must :
- •a. Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a FCBP while participating in the study, during dose interruptions and for at least 90 days following study treatment discontinuation, even if he has undergone a successful vasectomy.
- •b. Refrain from sperm and blood donation for at least 90 days after the final dose of durvalumab
- •8. For Cohort A subject must be transplant non-eligible (TNE) and meet at least one of the following high risk factors:
- •a. Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and / or del(17p); and / or 1q rearrangement; and / or t(14:16);or
- •b. ISS Stage III; or
- •c. Serum LDH > 2 x ULN
- •9. For Cohort B subject must be ? 65 years of age at the time of signing the informed consent form (ICF) and transplant non-eligible (TNE); excluding the subjects who meet the Cohort A criteria
- •10. For Cohort C subject must be after first autologous stem cell transplantation (ASCT) for NDMM and meet the following criteria:
- •a. Have a post-transplant response as PR or better at the time of enrollment to this study;
- •b. Have one of the following high risk factors at the time of NDMM diagnosis:
- •- Cytogenetic abnormalities finding in malignant myeloma clone with t(4; 14); and/ or del(17p); and / or 1q rearrangement; and / or t(14; 16); or
- •- ISS stage III; or
- •- Serum LDH > 2 x ULN;
- •c. MRD positive (defined as more than 1 malignant cell in 10^5 cells) measured by ClonoSIGHT? NGS assay of a BMA sample) at the time of enrollment to this study; BMA sample collected at the time of multiple myeloma diagnosis, prior to induction therapy available for central MRD assessment by ClonoSIGHT? NGS assay
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •1. Previous treatment with anti-myeloma therapy (does not include radiotherapy, bisphosphonates, or a single short course of steroid [ie, less than or equal to the equivalent of dexamethasone 40 mg/day for 4 days; such a short course of steroid treatment must not have been given within 14 days of Cycle 1 Day 1], for Cohort C, the induction and consolidation treatment along with the first ASCT are allowed)
- •2. Any of the following laboratory abnormalities:
- •a. Absolute neutrophil count (ANC) < 1,000/?L
- •b. Untransfused platelet count < 75,000 cells/?L
- •c. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (SGOT/AST) or alanine aminotransferase (SGPT/ALT) > 2.5 × upper limit of normal (ULN)
- •d. Serum total bilirubin > 1.5 × ULN or > 3.0 mg/dL for subjects with documented Gilbert?s syndrome
- •e. Corrected serum calcium >13.5 mg/dL (> 3.4 mmol/L)
- •3. Renal failure requiring hemodialysis or peritoneal dialysis
- •4. Any serious medical condition that places the subject at an unacceptable risk if he or she participates in this study. Examples of such a medical condition are, but are not limited to, subject with unstable cardiac disease as defined by: cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, uncontrolled atrial fibrillation or hypertension; subjects with conditions requiring chronic steroid or immunosuppressive treatment, such as rheumatoid arthritis, multiple sclerosis and lupus, that likely need additional steroid or immunosuppressive treatments in addition to the study treatment
- •5. Peripheral neuropathy ? Grade 2
- •6. Primary AL (immunoglobulin light-chain) amyloidosis and myeloma complicated by amyloidosis
- •7. Prior history of malignancies, other than MM, unless the subject has been free of the disease for ? 5 years with the exception of the following non-invasive malignancies:
- •a. Basal cell carcinoma of the skin
- •b. Squamous cell carcinoma of the skin
- •c. Carcinoma in situ of the cervix
- •d. Carcinoma in situ of the breast
- •e. Incidental histologic finding of prostate cancer (T1a or T1b using the TNM [tumor, nodes, metastasis] clinical staging system) or prostate cancer that is curative
- •8. Subjects is positive for human immunodeficiency virus (HIV); chronic or active hepatitis B or active hepatitis A, or C
- •9. Subject had prior exposure to immunotherapy, including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1 monoclonal antibody or inhibitor, cell-based therapies, or cancer vaccines
- •10. Subjects had history of organ or allogeneic stem cell transplantation
- •11. Subjects who have had clinical evidence of central nervous system (CNS) or pulmonary leukostasis, disseminated intravascular coagulation, or CNS multiple myeloma, or plasma cell leukemia
- •12. Known or suspected hypersensitivity to the excipients contained in the formulation of durvalumab, lenalidomide, or dexamethasone
- •13. Major surgery (as defined by the investigator) within the 28 days prior to the first dose of study treatment
- •14. Received prior treatment (for any reason)with a monoclonal antibody within 5 half-lives of initiating study treatment
- •15. Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of initiating study treatment
- •16. Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment. Exceptions to this criterion are detailed in the protocol
- •17. Active or pr
研究者
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