NL-OMON47210已完成不适用
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) - MEDI-4736-MM-002
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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,
- •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 amplification; 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
- •- Cytogenetic abnormalities finding in malignant myeloma clone with t(4;
- •14); and/ or del(17p); and / or 1q amplification; and / or t(14; 16); or
- 另有 7 项未显示
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/µL
- •b. Untransfused platelet count < 75,000 cells/µL
- •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
- 另有 6 项未显示
研究者
相似试验
进行中（未招募）
1 期
STUDY TO EVALUATE THE SAFETY AND ESTABLISH A SAFE DOSE OF DNL310 IN PEDIATRIC SUBJECTS WITH HUNTER SYNDROMEHunter Syndrome (Mucopolysaccharidosis Type II [MPS II])MedDRA version: 20.0Level: LLTClassification code 10056917Term: Hunter's syndromeSystem Organ Class: 100000004850EUCTR2019-004909-27-GBDenali Therapeutics Inc.16
进行中（未招募）
1 期
STUDY TO EVALUATE THE SAFETY AND ESTABLISH A SAFE DOSE OF DNL310 IN PEDIATRIC SUBJECTS WITH HUNTER SYNDROMEHunter Syndrome (Mucopolysaccharidosis Type II [MPS II])MedDRA version: 20.0Level: LLTClassification code 10056917Term: Hunter's syndromeSystem Organ Class: 100000004850EUCTR2019-004909-27-NLDenali Therapeutics Inc.16
进行中（未招募）
1 期
A study to determine the safety and efficacy for the combination of durvalumab and daratumumab (D2) to treat relapsed and refractory multiple myeloma.Relapsed and refractory multiple myelomaMedDRA version: 19.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2016-001209-17-ESCelgene International II Sàrl144
进行中（未招募）
1 期
A study to determine the safety and efficacy for the combination of durvalumab and daratumumab (D2) to treat relapsed and refractory multiple myeloma.EUCTR2016-001209-17-DKCelgene International II Sàrl144
进行中（未招募）
1 期
A study to determine the safety and efficacy for the combination of durvalumab and daratumumab (D2) to treat relapsed and refractory multiple myeloma.EUCTR2016-001209-17-BECelgene International II Sàrl144