Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
Recruiting now
Conditions studied: Multiple Mieloma
In brief
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.
Key facts
- Study ID
- NCT06874530
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 30
- Starts
- 2023-12-27
- Expected to finish
- 2026-01-31
- Last updated by the study team
- 2025-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- None
Where it is running
- IRCCS Azienda Ospedaliera-Universitaria di Bologna — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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