Isatuximab Treatment Outcomes in Relapsed Myeloma With 1q21 Gain
Studies how isatuximab-based treatment works in adults with relapsed myeloma and 1q21 gain.
Plain-language title generated from the registry record
Registry title: Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
Key facts
- Where
- Bologna, ItalySee the site
Where in Italy
- IRCCS Azienda Ospedaliera-Universitaria di BolognaBologna, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Trial code
- NCT06874530
- Record updated
- 13 March 2025
- Original description
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.Read full original descriptionShow less
Efficacy of Isatuximab-basedregimens in Relapsed/Refractory Multiple Myeloma With 1q21+
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.
Inclusion: 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.
Exclusion: None.