Condition: Myeloma Multiple · Sponsor: Jules Bordet Institute
Relapsed/refractory multiple myeloma (RRMM) predominantly affects older adults, who exhibit marked heterogeneity in treatment outcomes despite receiving the same therapies. Clinical frailty scores, such as the International Myeloma Working Group (IMWG) Frailty Index, predict survival and treatment tolerance but provide limited information on immune competence, a key determinant of response to T-cell-based immunotherapies. The PRIME study is a prospective, multicenter, non-interventional exploratory study designed to evaluate the relationship between immune fitness and clinical outcomes in patients aged 65 years or older with RRMM treated with standard-of-care chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies. Peripheral blood samples collected before treatment initiation will be analyzed to characterize T-cell differentiation, activation, senescence, exhaustion, and T-helper cell subsets using multiparametric immunophenotyping. Serum biomarkers, including soluble B-cell maturation antigen (sBCMA) and senescence-associated soluble markers, will also be assessed. * The primary objective is to determine whether baseline immune profiles are associated with quality of response at 3 months after treatment initiation. * Secondary objectives include evaluating the association between immune profiles and treatment-related toxicities, including cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), other neurological t…
This description comes directly from the study's public registry record.
Marie Vercruyssen, MD · +32497840746 · marie.vercruyssen@hubruxelles.be
Always discuss trial participation with your own doctor first.
| Institut Jules Bordet | Anderlecht, Brussels Capital, Belgium | Recruiting |
| CHU Saint-Pierre | Brussels, Brussels Capital, Belgium | Not Yet Recruiting |
| institut roi albert II | Woluwe-Saint-Lambert, Brussels Capital, Belgium | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT07674498