EUCTR2021-001242-35-CZ进行中（未招募）1 期
A Phase 3 Randomized Study Comparing Bortezomib, Lenalidomide and Dexamethasone (VRd) followed by Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell (CAR-T) Therapy Directed Against BCMA versus Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by Lenalidomide and Dexamethasone (Rd) Therapy in Participants with Newly Diagnosed Multiple Myeloma for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy - CARTITUDE-5
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
- 650
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study:
- •Age, Type of Participant, and Disease Characteristic
- •1. =18 years of age
- •2. Documented diagnosis of MM according to IMWG diagnostic criteria
- •3. 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 MM in whom only measurable disease is by serum free light chain (FLC) levels: Serum Ig free light chain =10 mg/dL and abnormal serum Ig kappa/lambda FLC ratio.
- •4. Not considered for high-dose chemotherapy with autologous stem cell transplant (ASCT) due to:
- •Ineligible due to advanced age; or
- •Ineligible due to 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.
- •5. Eastern Cooperative Oncology Group Performance Status grade of 0 or 1
- •Contraceptive/Barrier Requirements
- •6. A woman of childbearing potential (WOCBP) must have 2 negative highly sensitive serum or urine pregnancy test (beta-human chorionic gonadotropin) tests prior to starting VRd and must agree to further testing during the study. See Section 10.9, for the definition of females who are not of reproductive potential.
- •7. When a woman is of childbearing potential, the participant must commit either to abstaining continuously from heterosexual intercourse or agree to practice 2 methods of reliable birth control simultaneously, ie, one highly effective method of contraception (failure rate of <1% per year when used consistently and correctly; see examples below) and one other effective method (ie, male latex or synthetic condom, diaphragm, or cervical cap).The participant must agree to remain on both methods of birth control, without interruption, from the time of signing the informed consent or for at least 4 weeks before therapy (whichever is earlier) until at least 4 weeks following the last dose of lenalidomide, 3 months after receiving the last dose of bortezomib, or 1 year after receiving the conditioning regimen (cyclophosphamide and fludarabine) or 1 year after receiving cilta-cel infusion (whichever is later) (Section 10.9). Reliable contraception is indicated even where there has been a history of infertility, unless it is due to hysterectomy. Women of childbearing potential should be referred to a qualified provider of contraceptive methods, if needed. Examples of highly effective contraceptives include:
- •User-independent methods: 1) implantable progestogen-only hormone contraception associated with inhibition of ovulation; 2) intrauterine device; intrauterine hormone releasing system; 3) vasectomized partner.
- •User-dependent method: progestogen-only hormone contraception associated with inhibition of ovulation (oral or injectable). Estrogen-containing hormonal contraception is contraindicated due to increased risk of thromboembolic events with lenalidomide.
- •Women of childbearing potential must follow the contraception criteria outlined in the global REVLIMID® (or generic lenalidomide) pregnancy prevention program or equivalent local Risk
- •Evaluation and Mitigation Strategy, whichever is more stringent, as applicable in their region.
- •8. A man must commit either to abstaining continuously from heterosexual intercourse or a man
- •Who is sexually active with a WOCBP or a pregnant woman must agree to use a b
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •Medical Condition
- •1. Frailty index of = 2 according to Myeloma Geriatric Assessment score
- •2. Active malignancies (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. The only allowed exceptions are:
- •non-muscle invasive bladder cancer treated within the last 24 months that is considered completely cured.
- •skin cancer (non-melanoma or melanoma) treated within the last 24 months that is considered completely cured.
- •non-invasive cervical cancer treated within the last 24 months that is considered completely cured.
- •localized prostate cancer (N0M0):
- •- with a Gleason score of =6, treated within the last 24 months or untreated and under surveillance,
- •- with a Gleason score of 3+4 that has been treated more than 6 months prior to full study screening and considered to have a very low risk of recurrence, or
- •- history of localized prostate cancer and receiving androgen deprivation therapy and considered to have a very low risk of recurrence.
- •breast cancer: adequately treated lobular carcinoma in situ or ductal carcinoma in situ, or history of localized breast cancer and receiving antihormonal agents and considered to have a very low risk of recurrence.
- •malignancy that is considered cured with minimal risk of recurrence.
- •3. Peripheral neuropathy or neuropathic pain Grade 2 or higher, as defined by the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.
- •4. 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 enrollment
- •History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
- •History of severe non-ischemic cardiomyopathy
- •Screening 12-lead ECG showing a baseline corrected Prolonged corrected QT interval (QTc) >470 msec (for women) and >450 msec (for men), as assessed by 12-lead ECG, except in participants with a pacemaker.
- •Impaired cardiac function (left ventricular ejection fraction <45%) as assessed by echocardiogram or multiple-gated acquisition (MUGA) scan.
- •5. Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM.
- •6. Stroke or seizure within 6 months of signing ICF.
- •7. Plasma cell leukemia at the time of screening (>2.0 x 10^9/L plasma cells by standard differential), Waldenström’s macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary amyloid light-chain amyloidosis.
- •8. Seropositive for human immunodeficiency virus (HIV).
- •9. Vaccinated with live, attenuated vaccine within 4 weeks prior to first dose of VRd.
- •10. Hepatitis B infection. In the event the infection status is unclear, quantitative levels are necessary to determine the infection status
- •11. Hepatitis C infection (defined as anti-hepatitis C virus [HCV] antibody positive or detectable HCV-RNA) or known to have a history of hepatitis C.
- •12. Participant must not require continuous supplemental oxygen.
- •13. Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including cyclophosphamide or fludarabine (if known) or any of their
研究者
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