MyelomaIMPACTNCT07878208
Immunoprofiling of the Patient Tumor Microenvironment in BCMA Targeted Therapies
An observational study of Myeloma, run by Odense University Hospital at 7 sites in 2 countries.
Trial summary
The main goal of the project is to characterize the bone marrow immunological milieu and investigate potential treatment defining events of the tumor microenvironment in relapsed and refractory multiple myeloma (RRMM) patients receiving BCMA-targeted therapies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- How many people
- 50 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 1 Oct 2026to 30 Sep 2030
- 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: To characterize the bone marrow immunological milieu and genomic profile post BCMA-targeted therapy and before initiation of subsequent treatment.
Who may be able to join
- Signed informed consent form.
- Participant age ≥ 18 years.
- Prior diagnosis of multiple myeloma according to the IMWG-criteria.
- Progressive disease as defined by IMWG during and after treatment with a BCMA-targeted therapy.
Who cannot join
- Initiated subsequent anti-myeloma treatment before inclusion.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
JAKOB NORDBERG NØRGAARD, MD, PhD contact
7 sites in 2 countries
Denmark6 sites
Aarhus University Hospital
Aarhus
Maja Ølholm Vase, MD, PhD, +45 78 45 00 00, majavase@rm.dk
Copenhagen University Hospital
Copenhagen
Agoston Szabo, MD, PhD, +45 35 45 35 45, agoston.gyula.szabo@regionh.dk
Regional Hospital Gødstrup
Gødstrup
Lene Kongsgaard Nielsen, MD, PhD, +45 78 43 00 00, lene.kongsgaard.nielsen@midt.rm.dk
Odense University Hospital
Odense
Jakub Krejcik, MD, PhD, +45 66 11 33 33, jakub.krejcik@rsyd.dk
Zealand University Hospital, Roskilde
Roskilde
Nicolai Grønne Dahlager Jørgensen, MD, PhD, +45 46 32 32 00, ngje@regionsjaelland.dk
Vejle Hospital
Vejle
Thomas Lund, MD, PhD, +45 79 40 50 00, Thomas.Lund2@rsyd.dk
Norway1 site
Oslo University Hospital
Oslo, Oslo, 0450
Jakob NORDBERG NØRGAARD, MD, PhD
About this study
The main goal of the project is to characterize the bone marrow immunological milieu and investigate potential treatment defining events of the tumor microenvironment in relapsed and refractory multiple myeloma (RRMM) patients receiving BCMA-targeted therapies.
Read the detailed description
This is a non-interventional, multicenter study conducted in collaboration with the Nordic Myeloma Study Group (NMSG). The study comprises a translational element and a prospective observational cohort. The primary objective of the study is to characterize the bone marrow immunological milieu and genomic profile post BCMA-targeted therapy and before initiation of subsequent treatment.
- Conditions
- Myeloma
- Keywords
- Tumor Microenvironment in BCMA Targeted Therapies
- Medical subject headings
- Neoplasms, Plasma Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
T-cell compartment fitness at the time of disease progression
Measured: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.
Genetic status of the BCMA locus at relapse following BCMA-targeted therapy
Measured: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878208
- Sponsor's protocol ID
- NMSG 42/26
- Acronym
- IMPACT
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoprofiling of the Patient Tumor Microenvironment in BCMA Targeted Therapies
- ClinicalTrials.gov ID
- NCT07878208
- Acronym / sponsor ID
- IMPACT / NMSG 42/26
- Conditions
- Myeloma
- Keywords
- Tumor Microenvironment in BCMA Targeted Therapies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 16 Oct 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 main goal of the project is to characterize the bone marrow immunological milieu and investigate potential treatment defining events of the tumor microenvironment in relapsed and refractory multiple myeloma (RRMM) patients receiving BCMA-targeted therapies.
Detailed description
This is a non-interventional, multicenter study conducted in collaboration with the Nordic Myeloma Study Group (NMSG). The study comprises a translational element and a prospective observational cohort. The primary objective of the study is to characterize the bone marrow immunological milieu and genomic profile post BCMA-targeted therapy and before initiation of subsequent treatment.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To characterize the bone marrow immunological milieu and genomic profile post BCMA-targeted therapy and before initiation of subsequent treatment.
Key inclusion criteria (4 listed)
- Signed informed consent form.
- Participant age ≥ 18 years.
- Prior diagnosis of multiple myeloma according to the IMWG-criteria.
- Progressive disease as defined by IMWG during and after treatment with a BCMA-targeted therapy.
Key exclusion criteria (1 listed)
- Initiated subsequent anti-myeloma treatment before inclusion.
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
T-cell compartment fitness at the time of disease progression
Time frame: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.
Genetic status of the BCMA locus at relapse following BCMA-targeted therapy
Time frame: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.
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 16 Oct 2026.
- Individual participant dataSharing planned: No
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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.
JAKOB NORDBERG NØRGAARD, MD, PhD contact
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma, run by Odense University Hospital at 7 sites in 2 countries.
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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark, Norway. 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 Jakub Krejcik, MD, PhD (+4540337294, jakub.krejcik@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T-cell compartment fitness at the time of disease progression (time frame: At the time of relapse: Bone marrow sampling will be performed within 4 weeks of relapse, as defined according to IMWG criteria, and prior to initiation of subsequent therapy.). 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 16 Oct 2026.