Ciltacabtagene Autoleucel in High-Risk Smoldering Multiple Myeloma

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.

NCT Number	NCT06574126
Lead Sponsor	PETHEMA Foundation
Conditions	High Risk Smoldering Multiple Myeloma
Enrollment	20 participants
Start Date	2024-09-30
Primary Completion	2032-09-30 (estimated)
Study Completion	2032-09-30 (estimated)
Updated on ClinicalTrials.gov	2024-10-26