Clinical trial with dasatinib for the prevention of CAR-T side effects in patients with relapsed or treatment-resistant multiple myeloma undergoing therapy with idecabtagene vicleucel
- Conditions
- Chimeric antigen receptor T cell therapy-associated cytokine release syndromeMedDRA version: 26.1Level: PTClassification code: 10052015Term: Cytokine release syndrome Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2023-507537-16-00
- Lead Sponsor
- niversitaetsklinikum Wuerzburg AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 55
Subject is = 18 years of age at the time of signing the informed consent form (ICF)., Subject has the capacity for consenting, was informed about the nature, the scope, and the relevance of the clinical study, voluntarily agrees in participation and in the study provisions, and duly signed the informed consent form approved by the ethics committee before any study-related procedure is performed., Subject has documented diagnosis of RRMM as defined by International Myeloma Working Group (IMWG) criteria., Subject is eligible for approved CAR T therapy with ide-cel in accordance with the ap-proved indication., An ide-cel production slot is available for the patient., An ide-cel product conforming to release specification is available for the subject; only applicable for day -8 confirmatory Screening., Female subjects of childbearing potential must have a negative pregnancy test (blood) at screening commit to true abstinence from heterosexual contact or agree to use, and be able to comply with, highly effective measures of contraception without interruption, from screening through 1 year following the IMP treatment. A highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and correctly) must be practiced. The subject should be informed of the potential risks associated with becoming pregnant while enrolled in this clinical trial. Reliable methods for this trial are: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence or vasectomized sexual partner. Abstinence is only accepted as true abstinence: when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g. calendar, ovulation, symptothermal, post-ovulation methods and withdrawal] are not acceptable methods of contraception.) Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile female subjects (tubal ligation, hysterectomy or bilateral oophorectomy) may be enrolled., Male patients must practice true abstinence or agree to use a condom during sexual contact with a pregnant woman or a woman of childbearing potential for the study duration.
Subject has any significant medical condition, or psychiatric illness (including lab abnormalities) that could interfere with subject's safety or compliance to the study procedures., Subject is a female who is pregnant, nursing, or breastfeeding, or who intends to become pregnant during the participation in the study., Subject diagnosed or treated for another malignancy within 5 years before enrolment or previously diagnosed with another malignancy and any evidence of residual disease. Participants with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection, Carcinoma in situ of the breast, Incidental histologic finding of prostate cancer [T1a or T1b] or prostate cancer that is curative., Legal incapacity or limited legal capacity., Employees of the sponsor or employees or relatives of the investigator., Subject has received treatment with an IMP within 4 weeks prior to screening., Subject has known relevant pleural or pericardial effusion., Subjects receiving any of the following: a) CYP3A4 metabolized drugs with small therapeutic range including, but not limited to drugs listed in Protocol Appendix I (see Section 11.3) b) Patients receiving potent CYP3A4 inhibitors including, but not limited to drugs listed in Protocol Appendix J (see Section 11.3) c) Patients with concomitant medication of potent CYP3A4 inducers including, but not limited to drugs listed in Protocol Appendix K (see Section 11.3) – with the exemption of 1. cyclophosphamide if administered as part of the pre-treatment lymphodepletion chemotherapy prior to ide-cel or to control high-grade CRS (for details see summary of product characteristics [SmPC] for ide-cel); and 2. dexamethasone if administered for treatment of CRS, ICANS or haemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) (for details see SmPC for ide-cel) d) Patients who cannot be taken off drugs that have a risk of causing Torsades de pointes, including, but not limited to drugs listed in Protocol Appendix L (see Section 11.3) e) Concomitant medication with H2 inhibitors, proton pump inhibitors or antacids (e.g. aluminium hydroxide/magnesium hydroxide, see Protocol Section 11.3) f) Subjects who have discontinued any of these medications must have a wash-out period of at least 2 days prior to the first dose of dasatinib. If the drugs listed in Protocol Appendices H-K cannot be discontinued in a subject, but the subject is otherwise eligible for participation in the clinical trial, the sponsor should be contacted., Cardiac symptoms or cardiovascular disease, including: a) Myocardial infarction or unstable angina pectoris within 6 months prior to screening b) Congestive heart failure with left ventricular ejection fraction (EF <45% in last cardiologic assessment in the last 3 months) c) Diagnosed or suspected congenital long QT syndrome d) Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes) e) Prolonged QTc interval on screening electrocardiogram (greater than 450 msec) on Bazett's correction f) Subject has known pulmonary arterial hypertension., Subject is positive for human immunodeficiency virus (HIV), chronic or active hepatitis B or active hepatitis A or C or has active Cytomegalovirus (CMV) infection/reactivation., Subject has systemic and uncontrolled fungal, bacterial, viral or other infection. Uncontrolled defined as exhibiti
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method