EUCTR2022-000909-28-PT进行中（未招募）1 期
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd) in Participants with Newly Diagnosed Multiple Myeloma Who are Either Ineligible or not Intended for Autologous Stem Cell Transplant as Initial Therapy - MajesTEC-7
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
- 1,030
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. =18 years of age
- •2. Have a diagnosis of multiple myeloma according to the IMWG diagnostic criteria.
- •3. Be newly diagnosed and not considered a candidate for high-dose chemotherapy with ASCT due to
- •-Ineligible due to advanced age OR
- •-Ineligible due to the presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with ASCT OR
- •-Deferral of high-dose chemotherapy with ASCT as initial treatment.
- •4. Measurable disease at Screening as defined by any of the following:
- •-Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level =200 mg/24 hours; or
- •-Light chain multiple myeloma in whom only measurable disease is by sFLC levels: Serum Ig free light chain =10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
- •5. Have an ECOG performance status score of 0 to 2.
- •6. Have clinical laboratory values meeting the criteria during the Screening Phase:
- •-Hemoglobin: =7.5 g/dL
- •-Platelets: =70×109/L in participants in whom <50% of bone marrow nucleated cells are plasma cells and =50×109/L in participants in whom =50% of bone marrow nucleated cells are plasma cells.
- •-Absolute neutrophil count: =1.0×109/L
- •-AST and ALT: =2.5×ULN
- •-Creatinine clearance: =30 mL/min based on Cockcroft-Gault
- •-Total bilirubin: =2.0 × ULN
- •-Serum calcium corrected for albumin: =14 mg/dL (=3.5 mmol/L) or free ionized calcium =6.5 mg/dL.
- •7. A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test at screening and 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 and in agreement with the global PPP or local PPP/REMS program for lenalidomide.
- •8. A female participant must be either of the following:
- •a. Not of childbearing potential, or
- •b. Of childbearing potential and practicing at least 2 methods of reliable contraception including 1 highly effective method of contraception throughout the study, during any dose interruptions, and through 3 months after the last dose of study treatment. Contraception must begin 4 weeks prior to dosing of lenalidomide. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.
- •9. A female participant 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 period of 3 months
- •after receiving the last dose of study treatment.
- •10. A male participant 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 3 months after receiving the last dose of study treatment. If the male participant’s partner is a female of childbearing potential, the male participant must use condoms (with or without spermicide) and the female partner of the male participant must also be practicing a highly effective method of contraception. A male participant who is vasectomized must still use a condom (with or without spermicide), but the partner is not required to use
- •contraception.
- •11. A male participant must agree not to donate sperm for the purposes of reproduction during the study and for 3 months after receiving the last dose of study treatment.
- •12. A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolle
排除标准
- •1. Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis.
- •2. Received a cumulative dose of systemic corticosteroids equivalent to =20 mg of dexamethasone within 14 days before randomization.
- •3. Received focal radiation therapy within 14 days of randomization.
- •4. Had plasmapheresis within 28 days of randomization.
- •5. Had a stroke, transient ischemic attack, or seizure within 6 months prior to randomization.
- •6. Has clinical signs of meningeal involvement of multiple myeloma.
- •7. Has COPD with an FEV1 <50% of predicted. (FEV1 testing is required for participants suspected of having COPD).
- •8. Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
- •9. Seropositive for hepatitis B: defined by a positive test HBsAg. 10. Has active hepatitis C infection as measured by positive HCV-RNA testing.
- •11. Participants who are human immunodeficiency virus-positive with 1 or more of the following:
- •a. History of AIDS-defining conditions
- •b. CD4 count <350 cells/mm3
- •c. Detectable viral load (ie, >50 copies/mL) during screening or within 6 months prior to randomization
- •d. Not receiving highly active antiretroviral therapy
- •e. Had a change in antiretroviral therapy within 6 months prior to randomization
- •f. Receiving antiretroviral therapy that may interfere with study treatment as assessed after discussion with the Medical Monitor.
- •12. Myelodysplastic syndrome or active malignancies other than multiple myeloma.
- •13. Participant has 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.
- •14. Presence of the following cardiac conditions:
- •-New York Heart Association stage III or IV congestive heart failure
- •-Myocardial infarction or coronary artery bypass graft =6 months prior to randomization
- •-History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- •-Uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities.
- •15. Participant had significant traumatic injury or major surgery within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from
- •surgery, or has major surgery planned during the time the participant is expected to be treated in the study.
- •16. Known allergies, hypersensitivity, or intolerance to teclistamab excipients.
- •17. Known contraindications to the use of daratumumab or lenalidomide per local prescribing information.
- •18. Taken any disallowed therapies before the planned first dose of study treatment.
- •19. Received live or live-attenuated vaccine(s) within 4 weeks prior to screening or plans to receive such vaccines during the study.
- •20. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
- •For a full list of exclusion criteria, please refer to section 5.2 of the study protocol.
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