EUCTR2022-000909-28-DK进行中（未招募）1 期
A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-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
- 1,590
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 outlined in the protocol during the Screening Phase.
- •7. A 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 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 from the time of signing the ICF until 6 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 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 6 months after receiving the last dose of study treatment.
- •10. A 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 100 days after receiving the last dose of study treatment. If the participant’s partner is of childbearing potential, the participant must use condoms (with or without spermicide) and the partner of the participant must also be practicing a highly effective method of contraception. A participant who is vasectomized must still use a condom (with or without spermicide), but the partner is not required to use contraception.
- •11. A participant must agree not to donate sperm for the purposes of reproduction during the study and for 100 days after receiving the last dose of study treatment.
- •12. A participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 6 months after the last dose of study treatment.
- •13. A participant must agree not to plan to father a child while enrolled in this study or within 100 days after the last dose of study treatment.
- •14. Must sign an ICF (or their legally acceptable representative must sign in accordance with local legislation) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- •15. Be willing and able to adhere to the lifestyle restric
排除标准
- •1. Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome, or primary amyloid light chain amyloidosis. Any treated plasma cell dyscrasia
- •2. Received any prior therapy for multiple myeloma or smoldering myeloma other than a short course of corticosteroids (not to exceed 40 mg of dexamethasone, or equivalent per day for a maximum of 4 days, total of 160 mg dexamethasone or equivalent). In addition, received a cumulative dose of systemic corticosteroids equivalent to =20 mg of dexamethasone during the Screening Phase.
- •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. CNS or 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 HIV-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.
- •a) Any ongoing myelodysplastic syndrome or B cell malignancy (other than multiple myeloma)
- •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 prior to randomization) 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, unstable angina, 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 or talquetamab 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 a live, attenuated vaccine within 4 weeks before randomization. Non-live or non-replicating vaccines authorized for emergency use are a
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