Condition: High Risk Smoldering Multiple Myeloma · Sponsor: PETHEMA Foundation
This is an open-label, single arm, multicenter, interventional study with Dara-VRD followed by cilta-cel in high-risk smoldering multiple myeloma (SMM) patients. The primary objectives of this trial, related with efficafy and safety of the treatment, are i) to evaluate the proportion of high-risk SMM patients with undetectable minimal residual disease (MRD) at 6 months, 12 months, and thereafter every 12 months up to 5 years after cilta-cel administration as well as the sustained undetectable MRD rate in the intent-to-treat (ITT) population; ii) to annotate frequency and severity of adverse events (AE) and serious adverse events (SAE), as well as data from laboratory tests aslo related with safety such as Immunoglobulin (Ig) G levels, complete blood count (CBC) cytopenia adn T-cell populations. Secondary objectives are related with response to therapy and will measure different categories of response and survival.
This description comes directly from the study's public registry record.
María-Victoria Mateos · +34 923 291 100 · mvmateos@usal.es
Jesús San Miguel
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| Hospital Clinico Universitario Salamanca | Salamanca, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06574126