NCT06874530|Recruiting
Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
Isa_1q21+
Efficacy of Isatuximab-basedregimens in Relapsed/Refractory Multiple Myeloma With 1q21+
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Isa_1q21+
Efficacy of Isatuximab-basedregimens in Relapsed/Refractory Multiple Myeloma With 1q21+
Sponsor study identifier
observational
30
1 country
1
Study Start
December 27, 2023
Actual (reported)Primary Completion
November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 27, 2023
Actual (reported)December 3, 2024
Actual (reported)March 13, 2025
Actual (reported)November 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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
Analysis group that based on cytogenetic profile has 1q21 aberrations.
Analysis group that based on cytogenetic profile absent for 1q21 aberration.
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.
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, 40138, Italy
First Submitted
December 3, 2024
First Posted
March 13, 2025
Study Start
December 27, 2023
Actual (reported)Primary Completion
November 30, 2025
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 13, 2025
Record last verified: 2024-11
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Source: ClinicalTrials.gov.
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