This is a non-interventional, national, multicentre retrospective and prospective observational study aiming at assessing the efficacy of isatuximab-based regimens in RRMM patients with 1q21+ in a real-life setting.
Due to the limited information as to isatuximab's impact in real-world settings and that MM is a rare cancer, patients will be enrolled both prospectively and retrospectively from approximately 8 haematologic/oncologic centers in Italy. Prospective enrollment will allow an assessment of true baseline and the beneficial treatment of isatuximab among RRMM patients with 1q21+. The inclusion of retrospectively enrolled patients previously exposed to isatuximab-based regimens (Isa-Pd and Isa-Kd) will allow for maximal data capture to evaluate isatuximab treatment as part of routine care.
All the sites participating in the study are using isatuximab-based regimens for the treatment of RRMM patients in clinical practice. According to data availability and/or clinical experience of the sites, data from approximately 150 patients consecutively treated in the participating centers will be collected in the present study and compared with data published in the literature.
Age ≥ 18 years
Signed Informed Consent form (whenever feasible)
Diagnosis of RRMM prior exposed to >1 lines of therapies including Isatuximab-based regimens
Availability of FISH results, including 1q2, at diagnosis and/or at relapse
None
Study participants will be adult patients with a diagnosis of RRMM with chromosomal 1q21 abnormality, previously exposed to \>1 lines of therapies including isatuximab-based regimens outside clinical trials. The study will aim to enroll up to approximately 150 patients with a recorded diagnosis of RRMM 1q21+, from various Italian clinical sites. All eligible patients will be consecutively proposed to be enrolled in the study. Patients will be asked to take part to the present study in the context of a follow-up visit, as per standard care practice. Documentation that informed consent occurred prior to the subject's entry into the study should be recorded in the subject's source documents.
Case-control
Other
Not listed
Hematologic response rate, according to the International Myeloma Working Group (IMWG) criteria8 in RRMM with 1q21+ treated with Isa-PD and Isa-KD
The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by Investigator using the IMWG response criteria.
PFS in RRMM with 1q21+ treated with Isa-Pd and Isa-Kd
Time from isatuximab start date to the date of first documentation of progressive disease (PD), as determined by the Investigator, or the date of death from any cause, whichever comes first.
TTP in RRMM with 1q21+ treated with Isa-PD and Isa-KD
Time from the initiation of isatuximab until progressive the according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Cytogenetic profile in RRMM patients with 1q21+.
Evaluation by FISH analysis
Minimal residual disease (MRD) in patients with and without 1q21+ treated with isatuximab
MRD negativity and sustained MRD negativity in patients with at least VGPR, sCR, or CR to determine the depth of response at the molecular level, where data are available as per standard of care. The MRD will be measured by next-generation sequencing in bone marrow aspiration whena vailable (sensitivity of 10-5).
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