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

NCT06874530 | Recruiting

• 1 other identifier: Isa_1q21+
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Mieloma

Keywords

Relapsed; Refractory; Isatuximab; 1q21+

Outcome Measures

Primary Outcomes (1)

• Hematologic response rate, according to the International Myeloma Working Group (IMWG) criteria8 in RRMM with 1q21+ treated with Isa-PD and Isa-KD

  The proportion of patients with stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response (PR) as best overall response assessed by Investigator using the IMWG response criteria.

  Within 12 months from the beginning of therapy.

Secondary Outcomes (5)

• PFS in RRMM with 1q21+ treated with Isa-Pd and Isa-Kd

  12 months after therapy initiation

• TTP in RRMM with 1q21+ treated with Isa-PD and Isa-KD

  12 months from the start of treatment.

• Cytogenetic profile in RRMM patients with 1q21+.

  Baseline

• Minimal residual disease (MRD) in patients with and without 1q21+ treated with isatuximab

  perioperatively/periprocedurally

• MRD in RRMM with gain(1q21) or amp(1q21) treated with isatuximab-based regimens.

  through study completion, once a year, an avarage of 2 years

Study Arms (2)

Analysis group that based on cytogenetic profile has 1q21 aberrations.

Analysis group that based on cytogenetic profile has 1q21 aberrations.

Analysis group that based on cytogenetic profile absent for 1q21 aberration.

Analysis group that based on cytogenetic profile absent for 1q21 aberration.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be adult patients with a diagnosis of RRMM with chromosomal 1q21 abnormality, previously exposed to \>1 lines of therapies including isatuximab-based regimens outside clinical trials. The study will aim to enroll up to approximately 150 patients with a recorded diagnosis of RRMM 1q21+, from various Italian clinical sites. All eligible patients will be consecutively proposed to be enrolled in the study. Patients will be asked to take part to the present study in the context of a follow-up visit, as per standard care practice. Documentation that informed consent occurred prior to the subject's entry into the study should be recorded in the subject's source documents.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliera-Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elena Zamagni, PI

CONTACT

+39 051 636 3 831; e.zamagni@unibo.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 8 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: March 13, 2025
• Study Start: December 27, 2023
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: March 13, 2025

Record last verified: 2024-11

Locations

IT (1)