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NCT06874530Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 13 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
30 (estimated)
First submitted
3 Dec 2024
Start date
27 Dec 2023
Primary completion date
30 Nov 2025
Lead sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
NCT number
NCT06874530

What you commit to

  • Study type: Observational
  • Planned participants: 30
  • From 27 Dec 2023 to the primary completion date, 30 Nov 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Coordinator of this site? Confirm its status
BolognaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.