EUCTR2020-004513-13-IT进行中（未招募）1 期
ISATUXIMAB AND AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION FOR RELAPSED MULTIPLE MYELOMA PATIENTS (Isabel Study) - Isabel
EMN RESEARCH ITALY IMPRESA SOCIALE S.R.L.0 个研究点目标入组 50 人开始时间: 2021年10月18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
- 50
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
- •a) Patient has given voluntary written informed consent
- •b) Patient is willing and able to comply with the study visits and procedures required per protocol
- •c) Subject must have at least 18 and = 70 years of age
- •d) Patient has a life-expectancy = 3 months
- •e) Subject has received an ASCT in the first line of therapy with a progression/relapse after at least 24 months
- •f) Subject must have received any cytoreductive treatment, excluding anti-CD38 antibodies containing regimens, as per local practice for the first relapse, according to local guidelines. Carfilzomib-based combinations are recommended (eg. carfilzomib-lenalidomide-dexamethasone or carfilzomib-dexamethasone). After the salvage duration phase (reinduction therapy), subject has achieved at least a PR according to IMWG Response criteria.
- •g) Subject must have documented relapsed MM as per IMWG criteria, and achieved at least a partial remission with treatments as per local guidelines
- •h) Subject must have at least 2.0 x 106 CD34+/Kg cryopreserved autologous stem cells
- •i) Subject must have an ECOG Performance Status score of 0, 1
- •j) Subject must have the following laboratory values:
- •o Platelet count =50 x 109/L (=30 x 109 /L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to drug administration)
- •o Absolute neutrophil count (ANC) = 1 x 109/L without the use of growth factors
- •o Corrected serum calcium =14 mg/dL (3.5 mmol/L)
- •o Alanine transaminase (ALT): = 3 x the ULN
- •o Total bilirubin: = 2 x the ULN
- •o Calculated or measured creatinine clearance: = 30 mL/minute
- •k) Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •o they are not females of childbearing potential (FCBP), OR
- •o they are FCBP who have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 – 14 days prior to and again within 24 hours of starting study medication and before each cycle of study treatment and must either commit to continue abstinence from heterosexual intercourse or apply a highly effective method of birth control during the intervention period and for at least 5 months after the last dose of study treatment. Of note: contraception duration should take also into consideration any backbone therapy
- •l) Male subjects must agree to use contraception on this protocol during the intervention period and for at least 5 months after the last dose of study treatment and refrain from donating sperm during this period
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Previous therapy with daratumumab, isatuximab or any other anti-CD38 monoclonal antibody
- •2. MM localization to the central nervous system
- •3. Subjects who have received any investigational drug within 14 days or 5 half-lives of the investigational drug from eligibility confirmation, whichever is longer. In case of very aggressive disease, delay could be shortened after agreement between Sponsor and Investigator, in absence of residual toxicities from previous therapy
- •4. Subjects who have received an allogeneic stem cell transplant
- •5. Subject with a history of malignancy (other than multiple myeloma) within 3 years before the date of eligibility confirmation (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, in agreement with the medical monitor, is considered cured with minimal risk of recurrence within 3 years)
- •6. Subject is known to be seropositive for human immunodeficiency virus (HIV) or with an active hepatitis A, B and C infection, defined as a positive test for hepatitis B surface antigen [HBsAg] and a positivity for HAV-RNA, HBV-DNA or HCV-RNA.
- •Uncontrolled or active HBV infection: patients with positive HBsAg and/or HBV DNA. Of note:
- •Subjects can be eligible if: anti-HBc IgG is positive (with or without positive anti-HBs) but HBsAg and HBV DNA are negative.
- •If anti-HBV therapy in relation with prior infection was started before initiation of study treatment, the anti-HBV therapy and monitoring should continue throughout the study treatment period.
- •Subjects with negative HBsAg and positive HBV DNA observed during screening period will be evaluated by a specialist for start of anti-viral treatment: study treatment could be proposed if HBV DNA becomes negative and all the other study criteria are still met.
- •Active HCV infection: positive HCV RNA and negative anti-HCV. Of note:
- •Subjects with antiviral therapy for HCV started before initiation of study treatment and positive HCV antibodies are eligible. The antiviral therapy for HCV should continue throughout the treatment period until seroconversion.
- •Patients with positive anti-HCV and undetectable HCV RNA without antiviral therapy for HCV are eligible.
- •7. Subject with any concurrent, clinically significant, uncontrolled medical condition or disease (eg, active systemic infection) 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
- •8. Subject with active tuberculosis and systemic or severe infections requiring treatment with an antibiotic parenteral administration
- •9. Subject with hypersensitivity or history of intolerance to steroids, mannitol, pregelatinized starch, sodium stearyl fumarate, histidine (as base and hydrochloride salt), arginine hydrochloride, poloxamer 188, sucrose or any of the other components of study therapy that are not amenable to premedication with steroids and H1 blockers or would prohibit further treatment with these agents
- •10. Subject with pulmonary deficit, defined as FEV1 <65% and/or DLCO <65%
- •11. Subject with clinically significant cardiac disease, including:
- •o LVEF <50%
- •o Myocardial infarction within 6 months before eligibility confirmation, or unstable or
- •o Uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV)
- •o Cardiac arrh
研究者
相似试验
进行中（未招募）
1 期
A trial for relapsed Multiple Myeloma patients (Isatuximab-dexamethasone)Relapsed Multiple MyelomaMedDRA version: 25.0Level: LLTClassification code: 10086466Term: Relapsed/refractory multiple myeloma Class: 100000004848MedDRA version: 21.0Level: LLTClassification code: 10028228Term: Multiple myeloma Class: 10029104CTIS2024-513397-21-00Emn Trial Office S.r.l. Impresa Sociale25
进行中（未招募）
2 期
A Trial for Relapsed Multiple Myeloma Patients (Isatuximab-dexamethasone)Relapsed Multiple MyelomaNCT04965155EMN Trial Office S.r.l. Impresa Sociale50
已完成
1 期
90Y-IBRITUMOMAB Tiuxetan and AHCI With HD Chemotherapy and Autologous Transplantation for Relapsed or Resistant NHLLymphoma, Non-HodgkinBlood and Marrow Transplant (BMT)NCT00186589Stanford University30
招募中
2 期
Post-Autologous Transplant Maintenance With Isatuximab and Lenalidomide in Minimal Residual Disease Positive Multiple MyelomaMultiple MyelomaNCT05344833University of Illinois at Chicago50
进行中（未招募）
1 期
Isatuximab in combination with Lenalidomide-Dexamethasone compared to Lenalidomide-Dexamethasone in elderly patients (aged =70 years) with newly diagnosed myeloma: a randomized phase II study (SGZ-2019-12650)ewly diagnosed, symptomatic multiple myeloma in elderly patientsMedDRA version: 16.1Level: HLTClassification code 10028229Term: Multiple myelomasSystem Organ Class: 100000004851EUCTR2020-004972-17-ATAGMT gGmbH198