CTIS2023-510384-36-00进行中（未招募）1 期
Phase 3 Study of Teclistamab in Combination With Lenalidomide and Teclistamab Alone versus Lenalidomide Alone in Participants With Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation – MajesTEC-4 - EMN30
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,522
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 65+（—）
- 性别
- All
入选标准
- •1.2 =18 years of age (and the legal age of consent in the jurisdiction in which the study is taking place) at the time of informed consent., 10.2 A woman must be: a)Not of childbearing potential, or b)Of childbearing potential practicing 2 reliable methods of contraception simultaneously including one highly effective method of contraception and one other effective method of contraception starting 4 weeks prior to dosing, throughout the study including during dose interruptions and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 6 months after the last dose of teclistamab, whichever occurs later. For participants who are of childbearing potential, see Section 6.11.3 for details regarding concomitant use of estrogen containing products and lenalidomide., 11.1 A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 6 months after the last dose of teclistamab, whichever occurs later., 12.2 A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 3 months after the last dose of teclistamab, whichever occurs later. If his female partner is of childbearing potential, the male participant must use condom (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception, 13.2 A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum of 4 weeks after the last dose of lenalidomide or for a minimum of 3 months after receiving the last dose of teclistamab, whichever occurs later, 14 Must be willing and able to adhere to the lifestyle restrictions specified in this protocol., 15.1 Must sign an informed consent form (ICF) (in accordance with the local requirements) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study., 2.2 Must have a new diagnosis of symptomatic MM according to IMWG criteria and have received 4 to 6 cycles of 3 or 4 drug-induction therapy that includes a proteasome inhibitor and/or an IMiD with or without anti-CD38 monoclonal antibody and a single or tandem ASCT. Post ASCT consolidation is permitted for up to 2 cycles as long as the total number of induction plus consolidation cycles does not exceed 6. Participants must complete all previous treatment prior to screening and at least 7 days prior to randomization (C1D1 for the safety run-in) except for cytotoxic therapy, which must be completed at least 21 days prior to randomization (C1D1 for the safety run-in)., 3.2 Must have received only one line of therapy and achieved at least a partial response (=PR) as per IMWG 2016 response criteria based on the investigator's assessment. Participants with plasmacytomas at the time of diagnosis must meet IMWG 2016 response criteria . for =PR based on repeat imaging utilizing the same modality (Kumar 2016)., 4 Must not be intolerant to the starting dose of lenalidomide., 5.2 Must have received high-dose chemotherapy and ASCT within 12 months of the start of induction therapy and be within 6 months of the las
排除标准
- •Criterion 1 was deleted, 10.1 Plasma cell leukemia, smoldering multiple myeloma, Waldenström's macroglobulinemia, POEMS syndrome or primary light chain amyloidosis., 11 Central nervous system involvement or exhibits clinical signs of meningeal involvement of multiple myeloma., 12.1 Stroke, transient ischemic attack, or seizure within 6 months of C1D1, 13 Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study treatment or its excipients, 14.1 Participant is pregnant or breast-feeding or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study drug, 15.1 Participant plans to father a child while enrolled in this study or within 3 months after the last dose of study drug, 16.1 Presence of the following conditions: a)New York Heart Association stage III or IV congestive heart failure b)Myocardial infarction, or coronary artery bypass graft =6 months prior to C1D1 c) History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration d) Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities, 17.1 Any of the following: a. HIV-positive participants with 1 or more of the following -History of AIDS-defining conditions -CD4 count <350 cells/mm3 at screening -Detectable viral load during screening or within six months prior to screening -Not receiving highly active ART -Had a change in antiretroviral therapy within 6 months of the start of screening -Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the Medical Monitor, 18 Hepatitis B infection: In the event the infection status is unclear, quantitative viral levels are necessary to determine the infection status, 19 Active hepatitis C infection as measured by positive HCV- RNA Testing. Participants with a history of HCV antibody positivity must undergo HCV-RNA testing. If a participant with history of chronic HCV infection completed antiviral therapy and has undetectable HCV-RNA 12 weeks following the completion of therapy, the participant is eligible for the study, 2 Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy, 20.2 Concurrent medical or psychiatric condition or disease, 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, 21.1 Participant had major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or has not fully recovered from an earlier surgery, or has major surgery planned during the time the participant is expected to participate in the study or within 2 weeks after administration of the last dose of study treatment, 22.1 Have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or 5 PK half-lives, whichever is longer, before C1D1 or is currently enrolled in an interventional investigational study except if only long term survival data is collected and after Sponsor approval is obtained, 3 Discontinued treatment due to any AE related to lenalidomide as determined by the investigator, 4.1 History of allogeneic stem cell transplantation or prior organ transplant, 5.1 Progressive disease as per IMWG 2016 response criteria at any time prior to rando
研究者
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