Actively Recruiting

Age: 18Years +
All Genders
NCT06874530

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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