Multiple MielomaNCT07611812
Real-World Patterns of Utilization of Lenalidomide-based Triplet Regimens in FIrst RElapsed Multiple Myeloma Patients: Evidence From Medical Record Review
An observational study of Multiple Mieloma and First Relpase, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
To compare progression-free survival (PFS) in patients with first-relapse multiple myeloma treated with Rd-based "triplets" (Daratumumab + Rd (DaraRd) vs Carfilzomib + Rd (KRd) vs. Elotuzumab + Rd (EloRd) vs. Ixazomib + Rd (IxaRd)) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Mieloma, First Relpase, Rd-base Triplet
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients referred to the hematology department of the coordinating center and the participating centers
Who may be able to join
- Patients with multiple myeloma (MM) at first relapse treated starting in January 2017 with RD-based triplets in accordance with current clinical practice
- Age ≥18 years
- Written informed consent signed by the patient
Who cannot join
- the patient's refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
To compare progression-free survival (PFS) in patients with first-relapse multiple myeloma treated with Rd-based "triplets" (Daratumumab + Rd (DaraRd) vs Carfilzomib + Rd (KRd) vs. Elotuzumab + Rd (EloRd) vs. Ixazomib + Rd (IxaRd))
- Conditions
- Multiple Mieloma, First Relpase, Rd-base Triplet
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of progression-free survival (PFS) in patients with multiple myeloma at first relapse treated with Rd-based "triplet" regimens (Daratumumab + Rd (DaraRd) vs Carfilzomib + Rd (KRd) vs Elotuzumab + Rd (EloRd) vs Ixazomib + Rd (IxaRd))
Measured: The study is expected to run for 24 months starting with the enrollment of the first patient in November 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start4 Feb 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2025
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 Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Mangiacavalli, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611812
- Sponsor's protocol ID
- FIRE-Prime Recidive
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Patterns of Utilization of Lenalidomide-based Triplet Regimens in FIrst RElapsed Multiple Myeloma Patients: Evidence From Medical Record Review
- ClinicalTrials.gov ID
- NCT07611812
- Acronym / sponsor ID
- FIRE-Prime Recidive
- Conditions
- Multiple Mieloma, First Relpase, Rd-base Triplet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 28 May 2026 (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.
To compare progression-free survival (PFS) in patients with first-relapse multiple myeloma treated with Rd-based "triplets" (Daratumumab + Rd (DaraRd) vs Carfilzomib + Rd (KRd) vs. Elotuzumab + Rd (EloRd) vs. Ixazomib + Rd (IxaRd))
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the hematology department of the coordinating center and the participating centers
Key inclusion criteria (3 listed)
- Patients with multiple myeloma (MM) at first relapse treated starting in January 2017 with RD-based triplets in accordance with current clinical practice
- Age ≥18 years
- Written informed consent signed by the patient
Key exclusion criteria (1 listed)
- the patient's refusal to participate
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
Comparison of progression-free survival (PFS) in patients with multiple myeloma at first relapse treated with Rd-based "triplet" regimens (Daratumumab + Rd (DaraRd) vs Carfilzomib + Rd (KRd) vs Elotuzumab + Rd (EloRd) vs Ixazomib + Rd (IxaRd))
Time frame: The study is expected to run for 24 months starting with the enrollment of the first patient in November 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and First Relpase, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 3 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: finished, as of the sponsor's last update on 28 May 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of progression-free survival (PFS) in patients with multiple myeloma at first relapse treated with Rd-based "triplet" regimens (Daratumumab + Rd (DaraRd) vs Carfilzomib + Rd (KRd) vs Elotuzumab + Rd (EloRd) vs Ixazomib + Rd (IxaRd)) (time frame: The study is expected to run for 24 months starting with the enrollment of the first patient in November 2020). 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 28 May 2026.