To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused.
Hospital U. de Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Clinica Universidad de Navarra
Pamplona, Navarre, Spain
Hospital Clinic of Barcelona
Barcelona, Spain
Hospital 12 de Octubre
Madrid, Spain
Overall response rate (ORR)
Time frame: 3 months
Cytokine release syndrome rate
Time frame: within 30 days of first infusion
Duration of the response
Time frame: up to 36 months after treatment
Response rate
Time frame: over the first year
Complete response rate (CR)
Time frame: at month 3 and month 6 of first infusion
Overall response rate (ORR)
Time frame: at month 6 of first infusion
Time to complete response
Time frame: up to 36 months after treatment
Response rate of extramedullary disease by PET-CT
Time frame: up to 36 months after treatment
Negative MRD rate in bone marrow
Time frame: at month 3 and month 6 of first infusion
Response rate of extramedullary disease by PET-TC
Time frame: at month 3
Progression free survival (PFS)
Time frame: at month 12, and up to 36 months after treatment
Overall survival (OS) defined as the time elapsed between the infusion of ARI0002h and the death of the patient from any cause
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Hospital Clínico Universitario Virgen de La Arrixaca
Murcia, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Del Rocío
Seville, Spain
Time frame: up to 36 months after treatment
Presence of tumor lysis syndrome
Time frame: up to 36 months after treatment
Presence of cytokine release syndrome
Time frame: up to 36 months after treatment
Presence of neurological toxicity
Time frame: up to 36 months after treatment
Presence of prolonged cytopenia
Time frame: up to 36 months after treatment
Persistence of CART BCMA ARI0002 in peripheral blood
Time frame: month 1, 2, 3, 4, 5, 6 and every 6 months until 2 years of follow up
Expression of BCMA
Time frame: at screening, at day +28, at day +100, at month 6, 12, 18 and 24
Levels of soluble BCMA in serum
Time frame: at screening, at day 0, +3, +7,+14,+28, +70 +100, at month 4, 5, 6, 7, 8, 9, 1,11, 12, 18 and 24