RecruitingNCT06874530

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

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


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

30 participants

Start Date

Dec 27, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking back at medical records to understand how well isatuximab-based drug combinations work in people with relapsed or refractory multiple myeloma (a blood cancer that has come back or stopped responding to treatment) who have a specific chromosomal abnormality called 1q21 gain or amplification. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with multiple myeloma that has relapsed or is not responding to treatment - You have received more than one previous line of therapy, including an isatuximab-based regimen - You have genetic test results (FISH) available showing whether you have the 1q21 abnormality, taken at diagnosis or at relapse **You may NOT be eligible if...** - There are no specific exclusion criteria listed for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, Italy

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NCT06874530


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