Actively Recruiting
Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-03-13
30
Participants Needed
1
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Signed informed consent form whenever feasible
- Diagnosis of relapsed or refractory multiple myeloma with prior exposure to more than one line of therapy including isatuximab-based regimens
- Availability of FISH test results, including 1q21 status, at diagnosis and/or relapse
You will not qualify if you...
- None
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
E
Elena Zamagni, PI
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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