NCT06874530 Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
| NCT ID | NCT06874530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Multiple Mieloma |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-12-27 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-12-27 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06874530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Mieloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06874530 currently recruiting?
Yes, NCT06874530 is actively recruiting participants. Contact the research team at e.zamagni@unibo.it for enrollment information.
Where is the NCT06874530 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06874530 clinical trial?
NCT06874530 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 30 participants.