Phase
Condition
Allogeneic Hematopoietic Stem Cell Transplant
Leukemia
Cancer/tumors
Treatment
CARTemis-1
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients > 18 years old with a diagnosis of post-allogeneic transplant relapsemultiple myeloma.
Measurable disease at the time of screening
Previous treatment with ≥2 lines before and/or after allogeneic transplant.
Patients who are not receiving immunosuppressants at least 1 month before inclusionand who do not have active graft-versus-host disease.
Eastern Cooperative Oncology Group functional status from 0 to 1.
Life expectancy greater than 3 months (at the time of screening)
Patients who give their consent by signing the Informed Consent document.
Exclusion
Exclusion Criteria:
Active systemic immunosuppressive treatment
Patients who have previously received treatment with CAR-T Anti-BCMA.
Absolute lymphocyte count <0.2x109/L
Previous neoplasm, except if it has been in complete remission >3 years, with theexception of skin carcinoma (non-melanoma)
Active infection requiring treatment.
Active HIV, hepatitis B virus or hepatitis C virus infection.
Uncontrolled medical illness.
Severe organic disease that meets any of the following criteria: left ventricularejection fraction <40%, carbon monoxide diffusion test <40%, glomerular filtrationrate <50 ml/min, bilirubin >3 normal value (except Gilbert syndrome).
Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis orPOEMS Syndrome.
Pregnant or lactating women.
Women of childbearing age, unable or unwilling to use highly effective contraceptivemethods.
Men who cannot or do not wish to use highly effective contraceptive methods. Thepartner of the male participants, if they are women of childbearing age, must alsouse highly effective contraceptive methods during the study period.
Contraindication to receive lymphodepleting chemotherapy.
Patients with known hypersensitivity to the active ingredients or any of theexcipients of the product to be infused.
Study Design
Study Description
Connect with a study center
Hospital Universitario Marques de Valdecilla
Santander, Cantabria 39008
SpainSite Not Available
Hospital Santa Creu i Sant Pau
Barcelona, 08025
SpainSite Not Available
Complejo asistencial universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
José Antonio Pérez Simón
Sevilla, 41011
SpainSite Not Available
Hospital Clínico de Valencia
Valencia, 46010
SpainSite Not Available

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