Newly Diagnosed Multiple Myeloma (NDMM)IMMPROVEDNCT07087964
Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Newly Diagnosed Multiple Myeloma Patients
An observational study of Newly Diagnosed Multiple Myeloma (NDMM), run by Universiteit Antwerpen at 4 sites in Belgium.
Trial summary
This study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Newly Diagnosed Multiple Myeloma (NDMM)
- How many people
- 120 participants
- Where
- 4 sitesBelgium
- Study dates
- 16 May 2022to 31 Dec 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: Newly diagnosed multiple myeloma patients will be included at participating centers: Universitair ziekenhuis Antwerpen, Universitair Ziekenhuis Gent, Universitair Ziekenhuis Leuven, AZ Sint-Jan Brugge and UMC Amsterdam (the Netherlands).
Who may be able to join
- Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiënts can also be included after ASCT, prior to maintenance therapy, if a baseline FDG-PET CT scan showing FDG avid disease is available.
- Baseline 18F-FDG PET/WBLDCT scan should be performed before start of treatment (preferably) or within 7 days after start of treatment. Scan must show FDG avid disease (=at least 1 FL ≥ DS3 and/or diffuse bone marrow involvement).
- WHO performance status 0-2 (WHO > 2 can be allowed if due to underlying disease and after discussion with the physician).
- Age ≥ 18 years
- Life expectancy > 12 months, based on clinical judgement.
- Eligibility criteria for the primary endpoint
- achieving at least a VGPR after induction chemotherapy and ASCT according to the standard IMWG response criteria.
- received at least one (28-day) cycle of lenalidomide as maintenance therapy after ASCT. No new therapy can be given until clinical relapse.
Who cannot join
- Any physical or physiological condition that may affect adherence to the study protocol, e.g. severe claustrophobia or the inability to lie still for 30 minutes.
- uncontrolled diabetes
- History of concomitant presence of any other malignancy, except for:
- non-melanoma skin cancer
- carinoma in situ of the cervix
- any other effectively treated malignancy that has been in remission for > 5 years or that is highly likely to be cured at the time of enrollment.
- pregnant or breastfeeding
- refusal or inability to provide written informed consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium4 sites, 4 recruiting
- Recruiting
Universitair ziekenhuis Antwerpen
Antwerp, Antwerpen, 2650
Sébastien Anguille, 03 821 5696, sebastien.anguille@uza.be
Sofie De Rechter, Prof. Dr., 03 821 31 43, sofie.derechter@uantwerpen.be
- Recruiting
AZ Sint-Jan Brugge
Bruges, West-Vlaandere, 8000
studiecoördinators hematologie, +32 50 45 31 66, helene.denil@azsintjan.be
Jan Van Droogenbroeck, Prof. Dr.
- Recruiting
Universitair ziekenhuis Gent
Ghent, Oost Vlaandere, 9000
studiecoördinators hematologie, 09 332 49 12, studies.hematologie@uzgent.be
Nicolas Kint
- Recruiting
Universitair Ziekenhuis Leuven
Leuven, Vlaams-Brabant, 3000
studiecoördinators hematologie, 01 634 19 69, yoline.soeffers@uzleuven.be
Christophe Deroose, Prof. Dr.
About this study
Official title: Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Myeloma
This study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Secondary endpoint is to gain more insight into diagnostic features to better stratify patients based on risk factors for early relapse. Both endpoints could lead to a more patient specific treatment in the future.
Participants will be followed throughout their standard of care treatment. This treatment consists of indcution chemotherapy, followed by autologous stem cell transplant (ASCT), followed by lenalidomide maintenance therapy.
- Before start of induction chemotherapy the patient will receive a whole-body FDG PET/LDCT scan and an additional bone marrow aspirate sample will be taken during a routine bone marrow punction. This sample will be used for whole exome sequencing (WES).
- For those patients who achieve at least a very good partial response (VGPR) after induction chemotherapy and ASCT a repeat whole body FDG PET/LDCT scan will be performed before start of maintenance therapy. This scan will be repeated for a third time after 1 year of maintenance therapy. Besides this, an additional bone marrow aspirate sample will be taken for MRD detection. This will be done before start of maintenance therapy, after 1 year of maintenance therapy and after 2 years of maintenance therapy. MRD detection is done by next generation flow cytometery (NGF).
- During mantenance therapy patient follow-up will be performed at least every 3 months to determine best response to therapy or possible relapse (based on routine lab information).
- Those patients who do not achieve VGPR or better will not need to receive a whole body FDG PET/CT scan and MRD detection by flow cytometry, but these patients will undergo the same follow-up during maintenance therapy.
- In case of relapse, for all patients, an additional bone marrow aspirate sample will be taken for WES (during a routine bone marrow investigation).
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
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 |
|---|---|---|
| Newly diagnosed Mulitple myeloma (NDMM) patients | Patients who recently received the diagnosis multiple myeloma and who will start a standard of care treatment consisting of induction chemotherapy and autologous stem cell transplantation (ASCT), followed by maintenance therapy. If a patient has already started therapy, it is still possible to be included in the study if following conditions are met: whole body FDG PET/LDCT scan at diagnosis and obtaining at least a very good partial response (VGPR) before start of maintenance therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prognostic value of MRD assessment by FDG-PET combined with NGF in patiënts achieving VGPR or better after induction chemotherapy and ASCT
The investigators hypothesize that only patients who have no evidence of disease on both NGF and FDG-PET (MRD double negative) have a durable response with a 2y PFS of 90% compared to 50% in patients who have evidence of disease on at least one modality (MRD positive).
PFS is defined as the time from achieving ≥ VGPR and confirmation of absence of MRD (landmark) to first documentation of objective progressive disease or death due to any cause, whichever occurs first.
The <10^-5 MRD level is used to define BM-NGF MRD negativity. A Deauville score = 3 threshold will be used to define FDG-PET MRD negativity, but alternatives will also be evaluated (other DS, more quantitative measures like SUV).
Measured: From achieving VGPR and measuring MRD by FDG PET/CT and NGF until the patiënt received 2 years of maintenance therapy (or until detection of progressive disease or dead, whichever occurs first).
Secondary outcomes (2)
Improvement of risk stratification at baseline - based on WES
The secondary endpoint is to implement WES and Radiomics at baseline to improve risk-stratification. Looking at WES-analysis: WES at baseline will be correlated with PFS duration, in order to explore wether certain WES signatures are correlated with shorter or longer PFS.
Measured: From diagnosis until progression, death or end of follow-up period (2years of maintenance therapy).
Improvement of risk stratification at baseline - based on radiomics
The secondary endpoint is to implement WES and Radiomics at baseline to improve risk-stratification. Lookting at radiomics: PET radiomics will be perforemd and correlated with PFS duration. Is there a significant difference (higher/lower) between patients with a PFS of >24 months vs patients who show PD during maintenance therapy (PFS < 24 months).
Measured: From diagnosis until progression, death or end of follow-up period (2years of maintenance therapy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start16 May 2022
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Multiple Myeloma (NDMM)Studies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiteit Antwerpen
- Sponsor type
- University, hospital or other
- Collaborators
- FWO Research Fund Flanders, Universitaire Ziekenhuizen KU Leuven, University Ghent, University Hospital, Antwerp, Amsterdam UMC, location VUmc, AZ Sint-Jan AV
- Responsible party
- Principal investigator, Sébastien Anguille, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087964
- Sponsor's protocol ID
- FWO-TBM T003420N
- Other IDs
- 2021-005864-22
- Acronym
- IMMPROVED
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Myeloma
- ClinicalTrials.gov ID
- NCT07087964
- Acronym / sponsor ID
- IMMPROVED / FWO-TBM T003420N
- Conditions
- Newly Diagnosed Multiple Myeloma (NDMM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Universiteit AntwerpenUniversity, hospital or other
- Collaborators
- FWO Research Fund Flanders, Universitaire Ziekenhuizen KU Leuven, University Ghent, University Hospital, Antwerp, Amsterdam UMC, location VUmc, AZ Sint-Jan AV
- Study start
- 16 May 2022 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Jul 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 study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Secondary endpoint is to gain more insight into diagnostic features to better stratify patients based on risk factors for early relapse. Both endpoints could lead to a more patient specific treatment in the future.
Participants will be followed throughout their standard of care treatment. This treatment consists of indcution chemotherapy, followed by autologous stem cell transplant (ASCT), followed by lenalidomide maintenance therapy.
- Before start of induction chemotherapy the patient will receive a whole-body FDG PET/LDCT scan and an additional bone marrow aspirate sample will be taken during a routine bone marrow punction. This sample will be used for whole exome sequencing (WES).
- For those patients who achieve at least a very good partial response (VGPR) after induction chemotherapy and ASCT a repeat whole body FDG PET/LDCT scan will be performed before start of maintenance therapy. This scan will be repeated for a third time after 1 year of maintenance therapy. Besides this, an additional bone marrow aspirate sample will be taken for MRD detection. This will be done before start of maintenance therapy, after 1 year of maintenance therapy and after 2 years of maintenance therapy. MRD detection is done by next generation flow cytometery (NGF).
- During mantenance therapy patient follow-up will be performed at least every 3 months to determine best response to therapy or possible relapse (based on routine lab information).
- Those patients who do not achieve VGPR or better will not need to receive a whole body FDG PET/CT scan and MRD detection by flow cytometry, but these patients will undergo the same follow-up during maintenance therapy.
- In case of relapse, for all patients, an additional bone marrow aspirate sample will be taken for WES (during a routine bone marrow investigation).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed Mulitple myeloma (NDMM) patients | – | –Patients who recently received the diagnosis multiple myeloma and who will start a standard of care treatment consisting of induction chemotherapy and autologous stem cell transplantation (ASCT), followed by maintenance therapy. If a patient has already started therapy, it is still possible to be included in the study if following conditions are met: whole body FDG PET/LDCT scan at diagnosis and obtaining at least a very good partial response (VGPR) before start of maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed multiple myeloma patients will be included at participating centers: Universitair ziekenhuis Antwerpen, Universitair Ziekenhuis Gent, Universitair Ziekenhuis Leuven, AZ Sint-Jan Brugge and UMC Amsterdam (the Netherlands).
Key inclusion criteria (8 listed)
- Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiënts can also be included after ASCT, prior to maintenance therapy, if a baseline FDG-PET CT scan showing FDG avid disease is available.
- Baseline 18F-FDG PET/WBLDCT scan should be performed before start of treatment (preferably) or within 7 days after start of treatment. Scan must show FDG avid disease (=at least 1 FL ≥ DS3 and/or diffuse bone marrow involvement).
- WHO performance status 0-2 (WHO > 2 can be allowed if due to underlying disease and after discussion with the physician).
- Age ≥ 18 years
- Life expectancy > 12 months, based on clinical judgement.
Key exclusion criteria (8 listed)
- Any physical or physiological condition that may affect adherence to the study protocol, e.g. severe claustrophobia or the inability to lie still for 30 minutes.
- uncontrolled diabetes
- History of concomitant presence of any other malignancy, except for:
- pregnant or breastfeeding
- refusal or inability to provide written informed consent
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
Prognostic value of MRD assessment by FDG-PET combined with NGF in patiënts achieving VGPR or better after induction chemotherapy and ASCT
Time frame: From achieving VGPR and measuring MRD by FDG PET/CT and NGF until the patiënt received 2 years of maintenance therapy (or until detection of progressive disease or dead, whichever occurs first).
The investigators hypothesize that only patients who have no evidence of disease on both NGF and FDG-PET (MRD double negative) have a durable response with a 2y PFS of 90% compared to 50% in patients who have evidence of disease on at least one modality (MRD positive). PFS is defined as the time from achieving ≥ VGPR and confirmation of absence of MRD (landmark) to first documentation of objective progressive disease or death due to any cause, whichever occurs first. The <10^-5 MRD level is used to define BM-NGF MRD negativity. A Deauville score = 3 threshold will be used to define FDG-PET MRD negativity, but alternatives will also be evaluated (other DS, more quantitative measures like SUV).
2 secondary outcomes
Improvement of risk stratification at baseline - based on WES
Time frame: From diagnosis until progression, death or end of follow-up period (2years of maintenance therapy).
Improvement of risk stratification at baseline - based on radiomics
Time frame: From diagnosis until progression, death or end of follow-up period (2years of maintenance 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 28 Jul 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Multiple Myeloma (NDMM), run by Universiteit Antwerpen at 4 sites in Belgium.
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 8 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: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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 Sofie De Rechter (03 821 31 43, sofie.derechter@uantwerpen.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prognostic value of MRD assessment by FDG-PET combined with NGF in patiënts achieving VGPR or better after induction chemotherapy and ASCT (time frame: From achieving VGPR and measuring MRD by FDG PET/CT and NGF until the patiënt received 2 years of maintenance therapy (or until detection of progressive disease or dead, whichever occurs first).). 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 Jul 2025.