Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

30 Participants
are grouped into 2 trial groups