Relapsed and Refractory Multiple Myeloma (RRMM)NCT05673967
Real-World Clinical Outcomes in Patients With Relapsed/Refractory Multiple Myeloma
An observational study of Relapsed and Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
Primary Objective: 1. To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and Refractory Multiple Myeloma (RRMM)
- What is being tested?
- Non-Interventional
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2023to 28 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR).
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at baseline
- Confirmed diagnosis of active MM by IMWG diagnostic criteria
- Have myeloma that is response-evaluable with measurable disease by M-protein in serum or urine as specified in the IMWG response criteria.
- Triple-class exposed or refractory
Who cannot join
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin (POEMS) changes syndrome
- Known MM brain lesions or meningeal involvement
- History of neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure
- Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA) (or a diagnosis of congestive heart failure, cardiomyopathy, or valvular heart disease as a potential proxy)
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent
- Live or live attenuated vaccines
- Treated with B-cell maturation antigen (BCMA)-directed immunotherapies (BCMA antibody-drug conjugates are not excluded).
- Note: Other protocol-defined Inclusion/Exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Regeneron Research Facility
Tarrytown, New York, 10591
About this study
Official title: A Study to Characterize Treatment Patterns and Real-World Outcomes in Heavily Pretreated Patients With Relapsed and Refractory Multiple Myeloma (RRMM) and Similar Clinical Characteristics to Patients in the Phase 2 Cohort 2 of the R5458-ONC-1826 Trial
Primary Objective:
- To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and are triple-class exposed (TCE), or (b) are triple-class refractory (TCR), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial.
Read more
Secondary Objectives:
- To describe additional outcomes (duration of response [DOR], progression-free survival [PFS], overall survival [OS], and time to next treatment [TTNT]) in the same Benchmark Cohort population described in the primary objective.
- To describe distribution of treatment regimens, ORR, DOR, PFS, OS, and to compare ORR, PFS, OS, and TTNT in an Analysis Cohort consisting of real-world patients derived from the Benchmark Cohort described above who are weighted to align with the characteristics of patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial. Comparative analyses of PFS and OS will be performed conditional on sufficient maturity of survival data in the R5458-ONC-1826 (NCT03761108) trial at the time of analysis.
- Being tested
- Non-Interventional
- Keywords
- Real-World Outcomes, Multiple Myeloma (MM), Objective response rate (ORR), Triple-class exposed (TCE), Triple-class refractory (TCR), Progression-free survival (PFS), Overall survival (OS)
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionalOther
No study treatment will be administered on this study.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Real-world (RW) patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR), meet similar inclusion/exclusion criteria used to establish phase 2 cohort 2 of the R5458-ONC-1826 trial, and are initiating currently available therapies. Receives: Other: Non-Interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients exposed to each type of regimen by line of therapy (LOT)
Distribution of treatment regimens
Measured: Up to 6 years
Proportion of patients with objective response rate (ORR)
Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)
Measured: Up to 6 years
Secondary outcomes (4)
Duration of response (DOR)
Defined as time from the date of the first documented response (best overall response of sCR, CR, VGPR, PR) until the first date of progressive disease (PD) by International Myeloma Working Group (IMWG) or death due to any cause, whichever occurs first.
Measured: Up to 6 years
Progression-free survival (PFS)
Defined as time from the start of study treatment until the first date of PD by IMWG, or death due to any cause, whichever occurs first.
Measured: Up to 6 years
Overall survival (OS)
OS is measured from the start of study treatment until death due to any cause.
Measured: Up to 6 years
Time to next treatment (TTNT)
Defined as time from the start of study treatment until the initiation of the subsequent LOT.
Measured: Up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start9 Jan 2023
- Primary completion12 Sep 2024
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory Multiple Myeloma (RRMM)Studies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673967
- Sponsor's protocol ID
- R5458-ONC-21101
- Status last verified
- Apr 2025
- First submitted
- 21 Dec 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Characterize Treatment Patterns and Real-World Outcomes in Heavily Pretreated Patients With Relapsed and Refractory Multiple Myeloma (RRMM) and Similar Clinical Characteristics to Patients in the Phase 2 Cohort 2 of the R5458-ONC-1826 Trial
- ClinicalTrials.gov ID
- NCT05673967
- Acronym / sponsor ID
- R5458-ONC-21101
- Keywords
- Real-World Outcomes, Multiple Myeloma (MM), Objective response rate (ORR), Triple-class exposed (TCE), Triple-class refractory (TCR), Progression-free survival (PFS), Overall survival (OS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2023 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 6 Jan 2023 (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.
Primary Objective:
- To describe the distribution of treatment regimens and objective response rate (ORR) in a Benchmark Cohort of real-world patients with relapsed/refractory multiple myeloma (RRMM) who initiate treatment after meeting the following criteria: (1) have either (a) at least three prior lines (3L) and are triple-class exposed (TCE), or (b) are triple-class refractory (TCR), and (2) meet similar inclusion/exclusion criteria to patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial.
Secondary Objectives:
- To describe additional outcomes (duration of response [DOR], progression-free survival [PFS], overall survival [OS], and time to next treatment [TTNT]) in the same Benchmark Cohort population described in the primary objective.
- To describe distribution of treatment regimens, ORR, DOR, PFS, OS, and to compare ORR, PFS, OS, and TTNT in an Analysis Cohort consisting of real-world patients derived from the Benchmark Cohort described above who are weighted to align with the characteristics of patients in phase 2 cohort 2 of the R5458-ONC-1826 (NCT03761108) trial. Comparative analyses of PFS and OS will be performed conditional on sufficient maturity of survival data in the R5458-ONC-1826 (NCT03761108) trial at the time of analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: Non-InterventionalReal-world (RW) patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR), meet similar inclusion/exclusion criteria used to establish phase 2 cohort 2 of the R5458-ONC-1826 trial, and are initiating currently available therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with RRMM who have either at least three prior lines of therapy (LOT) and are triple-class exposed (3L+/TCE), or are triple-class refractory (TCR).
Key inclusion criteria (4 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status ≤1 at baseline
- Confirmed diagnosis of active MM by IMWG diagnostic criteria
- Have myeloma that is response-evaluable with measurable disease by M-protein in serum or urine as specified in the IMWG response criteria.
- Triple-class exposed or refractory
Key exclusion criteria (8 listed)
- Diagnosis of plasma cell leukemia, primary systemic light-chain amyloidosis (excluding myeloma-associated amyloidosis), Waldenström macroglobulinemia, or polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin (POEMS) changes syndrome
- Known MM brain lesions or meningeal involvement
- History of neurodegenerative condition, central nervous system (CNS) movement disorder, or seizure
- Cardiac ejection fraction <40% by echocardiogram or multi-gated acquisition scan (MUGA) (or a diagnosis of congestive heart failure, cardiomyopathy, or valvular heart disease as a potential proxy)
- Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionalNo study treatment will be administered on this study. | Other | Cohort 1 |
Primary outcome
Proportion of patients exposed to each type of regimen by line of therapy (LOT)
Time frame: Up to 6 years
Distribution of treatment regimens
Proportion of patients with objective response rate (ORR)
Time frame: Up to 6 years
Defined as stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR)
4 secondary outcomes
Duration of response (DOR)
Time frame: Up to 6 years
Progression-free survival (PFS)
Time frame: Up to 6 years
Overall survival (OS)
Time frame: Up to 6 years
Time to next treatment (TTNT)
Time frame: Up to 6 years
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 25 Apr 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. This study is not recruiting at the moment.
Clinical Trial Management study director
Regeneron Pharmaceuticals
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 Relapsed and Refractory Multiple Myeloma (RRMM), run by Regeneron Pharmaceuticals at 1 site in United States.
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 8 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 25 Apr 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 United States. 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?
Proportion of patients exposed to each type of regimen by line of therapy (LOT) (time frame: Up to 6 years). The study lists 2 primary outcomes in all. 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 25 Apr 2025.