Multiple MielomaIsa_1q21+NCT06874530
Efficacy of Isatuximab-based Regimens in Relapsed/Refractory Multiple Myeloma With 1q21+
An observational study of Multiple Mieloma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Mieloma
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 27 Dec 2023to 31 Jan 2026
- How long will I take part?
- 8 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliera-Universitaria di Bologna
Bologna, 40138
Elena Zamagni, PI, +39 051 636 3 831, e.zamagni@unibo.it
About this study
Official title: Efficacy of Isatuximab-basedregimens in Relapsed/Refractory Multiple Myeloma With 1q21+
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.
Read the detailed description
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.
Patients will receive or will have been previously prescribed isatuximab in combination with either pomalidomide and dexamethasone (Isa-Pd) or carfilzomib and dexamethasone (Isa-Kd), in routine clinical practice and independently of the proposal to be enrolled into this study.Given the observational nature of the study, the decision of the patients to take part in this study will have no impact on the current and/or future care they receive and patient current therapy, if any, will be maintained with no change.
No clinical study visits are mandated; visits will be scheduled by the treating physician according to patients-specific needs and local standard of care (SoC).
After receiving the signed informed consent form from the patient, the investigator will start documenting retrospective and prospective data using electronic data capture. Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria. After confirmation of the patient'seligibility, the patient's last visit, baseline characteristics, MM-related data and therapy-related data will be documented in the Case Report Form.
The primary objective of this retrospective and prospective study is to evaluate the efficacy of isatuximab-based regimens (Isa-Pd and Isa-Kd) for RRMM with 1q21+ in a real-life setting.
Secondary objectives aim at: • exploring the safety and tolerability profile of isatuximab-based regimens in RRMM patients with or without 1q21+ • defining which clinical and cytogenetic risk factors may be associated with 1q21+ (both gain and amplification) • exploring the prognostic impact of different 1q21+ subtypes (gain and amplification) in patients with RRMM, in terms of efficacy, safety and tolerability.
Two groups of analysis will be identified according to the cytogenetic profile (presence or absence of 1q aberrations). The efficacy of isatuximab-based regimens Isa-Pd and Isa-Kd in real-world practice will be compared among RRMM patients with and without 1q21 alteration.
- Conditions
- Multiple Mieloma
- Keywords
- Relapsed, Refractory, Isatuximab, 1q21+
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 12 months from the beginning of therapy.
Secondary outcomes (5)
PFS in RRMM with 1q21+ treated with Isa-Pd and Isa-Kd
Time from isatuximab start date to the date of first documentation of progressive disease (PD), as determined by the Investigator, or the date of death from any cause, whichever comes first.
Measured: 12 months after therapy initiation
TTP in RRMM with 1q21+ treated with Isa-PD and Isa-KD
Time from the initiation of isatuximab until progressive the according to the Common Terminology Criteria for Adverse Events v5.0 (CTCAE)
Measured: 12 months from the start of treatment.
Cytogenetic profile in RRMM patients with 1q21+.
Evaluation by FISH analysis
Measured: Baseline
Minimal residual disease (MRD) in patients with and without 1q21+ treated with isatuximab
MRD negativity and sustained MRD negativity in patients with at least VGPR, sCR, or CR to determine the depth of response at the molecular level, where data are available as per standard of care.
The MRD will be measured by next-generation sequencing in bone marrow aspiration whena vailable (sensitivity of 10-5).
Measured: perioperatively/periprocedurally
MRD in RRMM with gain(1q21) or amp(1q21) treated with isatuximab-based regimens.
Difference in the outcomes of patients with gain(1q21) and amp(1q21) treated with Isa-Pd/Isa-Kd.
Measured: through study completion, once a year, an avarage of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start27 Dec 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MielomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 8 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874530
- Sponsor's protocol ID
- Isa_1q21+
- Acronym
- Isa_1q21+
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Isatuximab-basedregimens in Relapsed/Refractory Multiple Myeloma With 1q21+
- ClinicalTrials.gov ID
- NCT06874530
- Acronym / sponsor ID
- Isa_1q21+ / Isa_1q21+
- Conditions
- Multiple Mieloma
- Keywords
- Relapsed, Refractory, Isatuximab, 1q21+
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 27 Dec 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Patients will receive or will have been previously prescribed isatuximab in combination with either pomalidomide and dexamethasone (Isa-Pd) or carfilzomib and dexamethasone (Isa-Kd), in routine clinical practice and independently of the proposal to be enrolled into this study.Given the observational nature of the study, the decision of the patients to take part in this study will have no impact on the current and/or future care they receive and patient current therapy, if any, will be maintained with no change.
No clinical study visits are mandated; visits will be scheduled by the treating physician according to patients-specific needs and local standard of care (SoC).
After receiving the signed informed consent form from the patient, the investigator will start documenting retrospective and prospective data using electronic data capture. Each investigator should collect data from patients fulfilling all inclusion and exclusion criteria. After confirmation of the patient'seligibility, the patient's last visit, baseline characteristics, MM-related data and therapy-related data will be documented in the Case Report Form.
The primary objective of this retrospective and prospective study is to evaluate the efficacy of isatuximab-based regimens (Isa-Pd and Isa-Kd) for RRMM with 1q21+ in a real-life setting.
Secondary objectives aim at: • exploring the safety and tolerability profile of isatuximab-based regimens in RRMM patients with or without 1q21+ • defining which clinical and cytogenetic risk factors may be associated with 1q21+ (both gain and amplification) • exploring the prognostic impact of different 1q21+ subtypes (gain and amplification) in patients with RRMM, in terms of efficacy, safety and tolerability.
Two groups of analysis will be identified according to the cytogenetic profile (presence or absence of 1q aberrations). The efficacy of isatuximab-based regimens Isa-Pd and Isa-Kd in real-world practice will be compared among RRMM patients with and without 1q21 alteration.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 8 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hematologic response rate, according to the International Myeloma Working Group (IMWG) criteria8 in RRMM with 1q21+ treated with Isa-PD and Isa-KD
Time frame: Within 12 months from the beginning of therapy.
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.
5 secondary outcomes
PFS in RRMM with 1q21+ treated with Isa-Pd and Isa-Kd
Time frame: 12 months after therapy initiation
TTP in RRMM with 1q21+ treated with Isa-PD and Isa-KD
Time frame: 12 months from the start of treatment.
Cytogenetic profile in RRMM patients with 1q21+.
Time frame: Baseline
Minimal residual disease (MRD) in patients with and without 1q21+ treated with isatuximab
Time frame: perioperatively/periprocedurally
MRD in RRMM with gain(1q21) or amp(1q21) treated with isatuximab-based regimens.
Time frame: through study completion, once a year, an avarage of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Mieloma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elena Zamagni, PI (+39 051 636 3 831, e.zamagni@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic response rate, according to the International Myeloma Working Group (IMWG) criteria8 in RRMM with 1q21+ treated with Isa-PD and Isa-KD (time frame: Within 12 months from the beginning of therapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.