MyelomaPhase 2CONPETNCT03314636
Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.
A Phase 2 study testing Carfilzomib, Lenalidomide and PET-CT in people with Myeloma, run by Oslo University Hospital at 4 sites in 3 countries.
Trial summary
A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- Carfilzomib, Lenalidomide and PET-CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 16 Mar 2018to 1 Nov 2026
- Phase
- Phase 2
- 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
Who may be able to join
- Prior confirmed diagnosis of multiple myeloma (2014).
- Received standard first line treatment with at least partial response. Standard first line treatment is defined as
- VRD, VTD or VCD followed by ASCT, or
- MPV at least 6 cycles, or no further reduction in monoclonal component the last 2 cycles, or
- Rd at least 9 cycles or no further reduction in monoclonal component the last 2 cycles.
- Carfilzomib naïve.
Show all 9Show fewer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count >35 x 109/L.
- At least very good partial remission (VGPR) from first line treatment
Who cannot join
- Change of first line treatment because of stabile or progressive disease.
- Major surgery within 28 days before enrollment.
- Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
- Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
- Central nervous system involvement.
- Uncontrolled heart disease, including congestive heart failure (NYHA III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
Show all 10Show fewer
- Uncontrolled hypertension or uncontrolled diabetes despite medication
- Active hepatitis B or C infection or known human immunodeficiency virus (HIV) positivity.
- Another active malignancy. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
- Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Denmark2 sites
Copenhagen University Hospital, Rigshospitalet
Copenhagen
Odense University Hospital
Odense
About this study
Official title: KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study
A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.
Read the detailed description
Patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (VGPR). Eligible performed regimens are defined in the protocol. All patients will perform a PET-CT, and PET-negative patients will be excluded from protocol treatment. The PET-positive patients will do a minimal residual disease (MRD-)evaluation in the bone marrow before entering treatment. After 4 28day cycles of Carfilzomib-Revlimid-Dexamethason, a new MRD and a new PET-CT will be performed, as measures of outcome. Patients will continue treatment as written in the protocol.
- Conditions
- Myeloma
- Being tested
- Carfilzomib, Lenalidomide, PET-CT, Dexamethasone
- Medical subject headings
- Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarfilzomibDrug
See in arm description
LenalidomideDrug
See in arm description
PET-CTDevice
See in arm description
DexamethasoneDrug
See in arm description
| Study group | Role | What they receive |
|---|---|---|
| PET-CT-positive patients | Experimental | Carfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles Receives: Drug: Carfilzomib; Drug: Lenalidomide; Device: PET-CT; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET negativity after induction
How many of PET positive patients will become PET negative after treatment
Measured: 1 month after induction
Secondary outcomes (1)
PET correlation with MRD Euroflow
Before intervention all patients are PET-CT positive. The investigators will measure minimal residual disease (MRD) with immuno-flow cytometry, at the same timepoint, and describe how many of the PET-CT patients, are MRD-negative and how many are MRD-positive. After the intervention the investigators will again do PET-CT and MRD by flow cytometry. The investigators will then describe how many PET-positive patients are MRD-positive and how many are MRD-negative. As well, the investigators will describe the same in the PET-CT negative patients.
Measured: 1 month after induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2017
- Study start16 Mar 2018
- Primary completion1 Nov 2021
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Oslo 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Myeloma Study Group
- Responsible party
- Principal investigator, Fredrik Hellem Schjesvold, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03314636
- Sponsor's protocol ID
- NMSG25/16
- Acronym
- CONPET
- Status last verified
- Mar 2025
- First submitted
- 8 Sep 2017
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rosenberg T, Moller S, Abildgaard N, Norgaard JN, Lysen A, Tsykonova G, Joao C, Vangsted A, Schjesvold F, Nielsen LK. Health-Related Quality of Life During Carfilzomib-Lenalidomide-Dexamethasone Consolidation: Findings From the Multiple Myeloma CONPET Study. Eur J Haematol. 2025 Mar;114(3):517-527. doi: 10.1111/ejh.14358. Epub 2024 Dec 5.
PubMed 39638553
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study
- ClinicalTrials.gov ID
- NCT03314636
- Acronym / sponsor ID
- CONPET / NMSG25/16
- Conditions
- Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Nordic Myeloma Study Group
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- 1 Nov 2021 (actual)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Oct 2017 (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.
A PET-CT will be performed on patients with myeloma after a standard first-line treatment. The PET-positive patients will receive 4 cycles of Carfilzomb-Revlimid-Dexamethason (KRd), before a new PET-CT will be performed.
Detailed description
Patients will be evaluated for inclusion after finishing first-line therapy, or after a sufficient amount of treatment in first-line, and a sufficient respons (VGPR). Eligible performed regimens are defined in the protocol. All patients will perform a PET-CT, and PET-negative patients will be excluded from protocol treatment. The PET-positive patients will do a minimal residual disease (MRD-)evaluation in the bone marrow before entering treatment. After 4 28day cycles of Carfilzomib-Revlimid-Dexamethason, a new MRD and a new PET-CT will be performed, as measures of outcome. Patients will continue treatment as written in the protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-CT-positive patients | Experimental | Drug: Carfilzomib, Drug: Lenalidomide, Device: PET-CT, Drug: DexamethasoneCarfilzomib 20/36mg/m2 days 1,2,8,9,15,16 Lenalidomide 25mg days 1-21 Dexamethasone 40mg days 1,8,15,22 28 day cycles 4 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Prior confirmed diagnosis of multiple myeloma (2014).
- Received standard first line treatment with at least partial response. Standard first line treatment is defined as
- Carfilzomib naïve.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Absolute neutrophil count (ANC) ≥ 0,5 x 109/L) and platelet count >35 x 109/L.
Key exclusion criteria (10 listed)
- Change of first line treatment because of stabile or progressive disease.
- Major surgery within 28 days before enrollment.
- Radiotherapy within 14 days before enrollment, but if the involved field is small, 7 days will be considered a sufficient interval before onset of the treatment.
- Glucocorticoid therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
- Central nervous system involvement.
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 |
|---|---|---|
| CarfilzomibSee in arm description | Drug | PET-CT-positive patients |
| LenalidomideSee in arm description | Drug | PET-CT-positive patients |
| PET-CTSee in arm description | Device | PET-CT-positive patients |
| DexamethasoneSee in arm description | Drug | PET-CT-positive patients |
Primary outcome
PET negativity after induction
Time frame: 1 month after induction
How many of PET positive patients will become PET negative after treatment
1 secondary outcome
PET correlation with MRD Euroflow
Time frame: 1 month after induction
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 8 Aug 2025.
- Derived from this study: PubMed 39638553Rosenberg T, Moller S, Abildgaard N, Norgaard JN, Lysen A, Tsykonova G, Joao C, Vangsted A, Schjesvold F, Nielsen LK. Health-Related Quality of Life During Carfilzomib-Lenalidomide-Dexamethasone Consolidation: Findings From the Multiple Myeloma CONPET Study. Eur J Haematol. 2025 Mar;114(3):517-527. doi: 10.1111/ejh.14358. Epub 2024 Dec 5.
- Individual participant dataSharing planned: No
Related trials for Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carfilzomib, Lenalidomide and PET-CT in people with Myeloma, run by Oslo University Hospital at 4 sites in 3 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 9 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 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 Denmark, Norway, Sweden. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
PET negativity after induction (time frame: 1 month after induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03314636, which also lists 1 linked publication.
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 8 Aug 2025.