跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NL-OMON56310
NL-OMON56310招募中3 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

Health Data Specialists Ireland Limited0 个研究点目标入组 70 人开始时间: 待定最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
70
研究概览入排标准研究者记录与标识符相似试验

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. >=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.
  • •2. Must have a new diagnosis of symptomatic multiple myeloma according to
  • •International Myeloma Working Group (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, except for cytotoxic therapy, which must
  • •be completed at least 21 days before randomization.
  • •3. 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 during screening
  • •utilizing the same modality (Kumar 2016).
  • •4. Must not be intolerant to the starting dose of lenalidomide (see Table 11).
  • •5. 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 at the time
  • •of randomization or at the time of Sponsor approval for participants in safety
  • •6. Must not have received any maintenance therapy.
  • •7. Have an Eastern Cooperative Oncology Group (ECOG) performance status score
  • •of 0-2 at screening and immediately prior to the start of administration of
  • •study treatment (see Appendix 7).
  • •8. Have clinical laboratory values meeting the following criteria
  • •Hemoglobin *8.0 g/dL (** mmol/L; without prior RBC transfusion within 7 days
  • •before the laboratory test; recombinant human erythropoietin use is permitted)
  • •Platelets >=75×109/L (without transfusion support or thrombopoietin receptor
  • •agonist within 7 days before the laboratory test)
  • •Absolute neutrophil count >=1.0×109/L (prior growth factor support is permitted
  • •but must be without support for 7 days for G-CSF or GM-CSF or 14 days for
  • •pegylated-G-CSF)
  • •AST and ALT <=2.5× upper limit of normal (ULN)
  • •Total bilirubin <=1.5×ULN; except in participants with congenital bilirubinemia,
  • •such as Gilbert syndrome (in which case direct bilirubin <=1.5×ULN is required)
  • •Serum calcium corrected for albumin <=14 mg/dL (<=3.5 mmol/L) or free ionized
  • •calcium <=6.5 mg/dL (<=1.6 mmol/L; see Appendix 10.
  • •Abbreviations: ALT=alanine aminotransferase; AST=aspartate aminotransferase;
  • •CrCl=creatinine clearance; G-CSF=granulocyte colony-stimulating factor;
  • •GM-CSF=granulocyte-macrophage colony-stimulating factor; RBC=red blood cell;
  • •ULN=upper limit of normal
  • •9. A woman of childbearing potential must have a negative 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. A woman must be (as defined in Appendix 11):
  • •a) Not of childbearing potential, or
  • •b) Of childbearing potential
  • •c) Practicing 2 reliable method

排除标准

  • •1. Received any prior BCMA-directed therapy. 2. Any previous therapy with an
  • •immune cell redirecting agent or gene modified adoptive cell therapy (eg,
  • •chimeric antigen receptor modified T cells, NK cells). 3. Discontinued
  • •treatment due to any AE related to lenalidomide as determined by the
  • •investigator. 4. History of allogeneic stem cell transplantation or prior organ
  • •transplant requiring immunosuppressive therapy. 5. Progressive disease as per
  • •IMWG 2016 response criteria at any time prior to randomization or C1D1 for
  • •participants in the safety run in. 6. Radiotherapy within 14 days or focal
  • •radiation within 7 days of C1D1. 7. Received a cumulative dose of
  • •corticosteroids equivalent to >=140 mg of dexamethasone within the 14 days prior
  • •to C1D1 (see Appendix 12). 8. Received a live, attenuated vaccine within 4
  • •weeks before C1D1. Non-live vaccines or non-replicating authorized for
  • •emergency use (eg. COVID-19) are allowed. 9. Myelodysplastic syndrome or any
  • •malignancy that has progressed or required treatment change in the last 24
  • •months). The only allowed exceptions are malignancies treated within the last
  • •24 months that are considered completely cured: a) Non-muscle invasive bladder
  • •cancer (solitary Ta-PUN-LMP or low grade, <3 cm, no CIS) b) Skin cancer
  • •(non-melanoma skin cancer treated with curative therapy melanoma or localized
  • •or melanoma) treated with curative surgical resection alone). c) Noninvasive
  • •cervical cancer d) Breast cancer: adequately treated lobular carcinoma in situ
  • •or ductal carcinoma in situ, or localized breast cancer and receiving
  • •antihormonal agents. e) e) Localized prostate cancer (N0M0) with a Gleason
  • •Score <7a, treated locally only (RP/RT/focal treatment) f) Other malignancy
  • •that is considered cured with minimal risk of recurrence. NOTE: In the event of
  • •any questions, consult with the sponsor*s medical monitor prior to enrolling a
  • •participant. 10. Plasma cell leukemia, smoldering multiple myeloma,
  • •Waldenstro*m*s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly,
  • •endocrinopathy, monoclonal protein, and skin changes), or primary light chain
  • •amyloidosis. 11. Central nervous system involvement or exhibits clinical signs
  • •of meningeal involvement of multiple myeloma. If either is suspected, brain
  • •magnetic resonance imaging (MRI) and lumbar cytology are required. 12. 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 (refer to IB and most
  • •recent applicable RSI). 14. 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. Participant plans to father a child
  • •while enrolled in this study or within 90 days after the last dose of study
  • •drug. 16. Presence of the following cardiac 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 electrocardiogram (ECG)
  • •abnormalities. 17. Any

研究者

发起方
Health Data Specialists Ireland Limited

相似试验

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 Transplantatioewly Diagnosed Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2021-002531-27-IEStichting European Myeloma Network (EMN)1,572
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 Transplantatioewly Diagnosed Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2021-002531-27-DKStichting European Myeloma Network (EMN)1,572
招募中
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 Transplantatio
EUCTR2021-002531-27-ATStichting European Myeloma Network (EMN)1,572
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 Transplantatioewly Diagnosed Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104
CTIS2023-510384-36-00European Myeloma Network Stichting1,522
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 Transplantatioewly Diagnosed Multiple MyelomaMedDRA version: 21.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
EUCTR2021-002531-27-NOStichting European Myeloma Network (EMN)1,572