Clinical trial Recruiting at 1 site Observational Ages 18 and up

Evaluating Isatuximab Treatments for Relapsed Multiple Myeloma with 1q21+

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

Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06874530 · Data updated 2026-11-12

This study is testing if a combination of isatuximab with other medications can help people with relapsed multiple myeloma who have a specific genetic marker called 1q21+.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment30 (estimated)
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
Academic / other
Drugs / interventionsIsatuximab
Locations1 site (Bologna)
StatusRecruiting
StartedDecember 27, 2023
Main results expectedNovember 30, 2025
Study endsJanuary 31, 2026
Registry record updatedMarch 13, 2025
Trial IDNCT06874530 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older with a diagnosis of relapsed/refractory multiple myeloma who have been previously treated with isatuximab-based regimens.

Probably not a fit

Patients who have not been previously treated with isatuximab or do not have the 1q21+ genetic marker may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the efficacy of isatuximab-based regimens in patients with relapsed/refractory multiple myeloma (RRMM) who have the 1q21+ genetic marker. It will enroll patients both prospectively and retrospectively from approximately eight hematologic and oncologic centers in Italy. The study will capture data on patients who have received isatuximab in combination with either pomalidomide and dexamethasone or carfilzomib and dexamethasone, allowing for a comprehensive evaluation of treatment outcomes in a real-world setting.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of isatuximab-based treatments for patients with a specific genetic profile in RRMM.

How similar studies have gone: While there is limited data on isatuximab's impact in real-world settings, similar studies have shown promise in evaluating treatment efficacy for multiple myeloma.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Where it's running

  • IRCCS Azienda Ospedaliera-Universitaria di Bologna
    Bologna, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.