Multiple MielomaRISENCT07564128
Infection Surveillance of R/R Multiple Myeloma Patients Treated With Elranatamab as Clinical Practice in Italy
An observational study of Multiple Mieloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
Trial summary
The primary objective of this study is to measure the infection rate and presentation pattern in first 12 months of therapy with elranatamab as standard clinical practice in adult patients with Relapsed/Refractory Multiple Myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Mieloma
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Feb 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with Relapsed/Refractory Multiple Myeloma treated with elranatamab as standard clinical practice
Who may be able to join
- adult patients (age >18 years) with no upper age limit
- confirmed Relapsed and Refractory Multiple Myeloma (RRMM) according to IMWG criteria (demonstrated disease progression on the last therapy (progressed on or within 60 days of last therapy).
- Patients must have received at least three (3) prior lines of therapy, including at least: one Immunomodulatory agent (e.g., Lenalidomide, Pomalidomide), one Proteasome Inhibitor (e.g., Bortezomib, Carfilzomib), one Anti-CD38 Monoclonal Antibody (e.g., Daratumumab, Isatuximab).
- Treatment with elranatamab within standard clinical practice
- Written informed consent signature
Who cannot join
- none
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Italian Registry for Infection Surveillance of Patients Undergoing Salvage Treatment With Elranatamab Monotherapy
The primary objective of this study is to measure the infection rate and presentation pattern in first 12 months of therapy with elranatamab as standard clinical practice in adult patients with Relapsed/Refractory Multiple Myeloma.
- Conditions
- Multiple Mieloma
- Keywords
- Relapsed/Refractory Multiple Myeloma, Infection Surveillance, Elranatamab
- Medical subject headings
- Multiple Myeloma
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 |
|---|---|---|
| Adult patients with R/R Multiple Myeloma treated with elranatamab as standard clinical practice | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection rate in the first 12 months of therapy with elranatamab
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (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.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564128
- Sponsor's protocol ID
- MM0426
- Acronym
- RISE
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Italian Registry for Infection Surveillance of Patients Undergoing Salvage Treatment With Elranatamab Monotherapy
- ClinicalTrials.gov ID
- NCT07564128
- Acronym / sponsor ID
- RISE / MM0426
- Conditions
- Multiple Mieloma
- Keywords
- Relapsed/Refractory Multiple Myeloma, Infection Surveillance, Elranatamab
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 4 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.
The primary objective of this study is to measure the infection rate and presentation pattern in first 12 months of therapy with elranatamab as standard clinical practice in adult patients with Relapsed/Refractory Multiple Myeloma.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with R/R Multiple Myeloma treated with elranatamab as standard clinical practice | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with Relapsed/Refractory Multiple Myeloma treated with elranatamab as standard clinical practice
Key inclusion criteria (5 listed)
- adult patients (age >18 years) with no upper age limit
- confirmed Relapsed and Refractory Multiple Myeloma (RRMM) according to IMWG criteria (demonstrated disease progression on the last therapy (progressed on or within 60 days of last therapy).
- Patients must have received at least three (3) prior lines of therapy, including at least: one Immunomodulatory agent (e.g., Lenalidomide, Pomalidomide), one Proteasome Inhibitor (e.g., Bortezomib, Carfilzomib), one Anti-CD38 Monoclonal Antibody (e.g., Daratumumab, Isatuximab).
- Treatment with elranatamab within standard clinical practice
- Written informed consent signature
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
Infection rate in the first 12 months of therapy with elranatamab
Time frame: 12 months
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 4 May 2026.
- Individual participant dataSharing planned: No
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Multiple Mieloma
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Mieloma, run by Gruppo Italiano Malattie EMatologiche dell'Adulto.
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 5 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: opening soon, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Paola Fazi (0039 0670390528, p.fazi@gimema.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infection rate in the first 12 months of therapy with elranatamab (time frame: 12 months). 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 4 May 2026.