EUCTR2021-002531-27-NO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
Stichting European Myeloma Network (EMN)0 个研究点目标入组 1,572 人开始时间: 2022年2月21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
- 1,572
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
- 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 taken place) at the time of informed consent.
- •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.
- •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 last ASCT (7 months for participants who received consolidation) at the time of randomization or at the time of Sponsors approval for participant in safety run-in.
- •6 Must not have received any maintenance therapy.
- •7.1 Have an ECOG performance status score of 0-2 at screening and immediately prior to the start of administration of study treatment.
- •8.1 Have clinical laboratory values meeting the following criteria (see the protocol)
- •9.1 A woman of childbearing potential must have a negative sensitive serum pregnancy test within 10-14 days prior to the start of study treatment and again either a serum or urine pregnancy test within 24 hours of the start of study treatment and must agree to further serum or urine pregnancy tests during the study.
- •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 wi
排除标准
- •Criterion 1 was deleted
- •2 Any previous therapy with an immune cell redirecting agent or gene modified adoptive cell therapy
- •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 randomization or C1D1 for participants in the safety run in
- •6.1 Radiotherapy within 14 days or focal radiation within 7 days of C1D1 7.2 Received a cumulative dose of corticosteroids equivalent to > 40 mg of dexamethasone within the 14 days prior to C1D1
- •8.1 Received a live, attenuated vaccine within 4 weeks before C1D1. Non-live vaccines or non-replicating authorized for emergency use are allowed
- •9.3 Excluded for any of the following
- •a) Any ongoing myelodysplastic syndrome or B cell malignancy (other than MM)
- •b) Any history of malignancy, other than multiple myeloma, which is considered at high risk of recurrence requiring systemic therapy
- •c) Any active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than multiple myeloma. The only allowed exceptions are malignancies treated within the last 24 months that are considered cured
- •1) Non-muscle invasive bladder cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no CIS)
- •2) Non-melanoma skin cancers treated with curative therapy melanoma or localized melanoma treated with curative surgical resection alone
- •3) Non-invasive cervical cancer
- •4) Breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer
- •5) Localized prostate cancer (M0, N0) with a Gleason Score =7a, treated locally only
- •6) Other malignancy that is considered cured with minimal risk of recurrence in consultation with the Sponsor's medical monitor
- •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
研究者
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