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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliera-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Elena Zamagni, PI
e.zamagni@unibo.it
+39 051 636 3 831
Time Frame
Start Date: 2023-12-27
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 30
Treatments
Analysis group that based on cytogenetic profile has 1q21 aberrations.
Analysis group that based on cytogenetic profile has 1q21 aberrations.
Analysis group that based on cytogenetic profile absent for 1q21 aberration.
Analysis group that based on cytogenetic profile absent for 1q21 aberration.
Related Therapeutic Areas
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov