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 type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Drugs / interventions | Isatuximab |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | December 27, 2023 |
| Main results expected | November 30, 2025 |
| Study ends | January 31, 2026 |
| Registry record updated | March 13, 2025 |
| Trial ID | NCT06874530 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
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Isatuximab-VRd for transplant-ineligible newly diagnosed multiple myeloma
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CM336 plus Isa-VR in newly diagnosed primary plasma cell leukemia
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Isatuximab, Iberdomide, Bortezomib, and Dexamethasone Induction in New Myeloma, Followed by Adaptive Consolidation and Maintenance for Transplant-Eligible Patients
This study tests a combination therapy for newly diagnosed, transplant-eligible multiple myeloma patients to see if risk- and response-guided maintenance and consolidation can improve outcomes.
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CM336 with Isatuximab for Newly Diagnosed Myeloma with Kidney Impairment
This study tests a CM336 and isatuximab regimen in adults with newly diagnosed multiple myeloma and kidney trouble to see if it helps.
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Selinexor with Carfilzomib, Isatuximab and Dexamethasone for relapsed or refractory multiple myeloma
This trial tests whether a four-drug combination can help adults with relapsed or refractory multiple myeloma when they've had at least one prior treatment.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.