Evaluating Isatuximab Treatments for Relapsed Multiple Myeloma with 1q21+
Efficacy of Isatuximab-basedregimens in Relapsed/Refractory Multiple Myeloma With 1q21+
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 type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | Isatuximab |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06874530 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bologna
- IRCCS Azienda Ospedaliera-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Elena Zamagni, PI
- Email: e.zamagni@unibo.it
- Phone: +39 051 636 3 831
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.