ClinicalTrials.gg
Active, not recruitingNCT03314636CONPETUpdated Aug 8, 2025

Intensified Treatment With Carfilzomib in Myeloma Patients Still PET-positive After First Line Treatment.

A Phase 2 interventional study of Carfilzomib and Lenalidomide in Myeloma, sponsored by Oslo University Hospital. Active, not recruiting at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-08.

Sponsored by Oslo University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies testing carfilzomib in Neoplasms, Plasma Cell — 2 open to participants now, 6 under way, none of them phase 3. carfilzomib · Neoplasms, Plasma Cell.

Enrollment
7th of 13
53 · median 53
Started
2018
with 2 others
Phase 2
7 of 13
none open now
Registered
7th of 13
by date
Lead sponsor
1 of 13
Oslo University Hospital

Among the 13 studies testing carfilzomib in Neoplasms, Plasma Cell, this one is the 7th largest by enrollment, is one of 3 that started in 2018, is one of 7 in phase 2, and was the 7th registered.

Neoplasms, Plasma Cell

710 studies on the registry are indexed under Neoplasms, Plasma Cell; 79 are open to participants now.

Browse Neoplasms, Plasma Cell studies →

Open to participants now

2 of the 13 studies testing carfilzomib in Neoplasms, Plasma Cell are open now, in 4 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 2 open studies →

About carfilzomib

carfilzomib: first FDA approval 2012 (KYPROLIS), first EMA approval 2015. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 58 Neoplasms, Plasma Cell studies recruiting now, 34 (59%) set no upper age limit and 12 (21%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies testing carfilzomib in Neoplasms, Plasma Cell, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Myeloma
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Prior confirmed diagnosis of multiple myeloma (2014).
  2. Received standard treatment with at least partial response. Standard first line treatment is defined as

    • VRD, VTD or VCD followed by , 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.
  3. Carfilzomib naïve.
  4. (ECOG) performance status 0-2.
  5. (ANC) ≥ 0,5 x 109/L) and count >35 x 109/L.
  6. At least very good partial remission (VGPR) from first line treatment

Exclusion criteria

Exclusion Criteria:

  1. Change of treatment because of stabile or progressive disease.
  2. Major surgery within 28 days before enrollment.
  3. 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.
  4. therapy within the 14 days prior to inclusion that exceeds a cumulative dose of 160 mg dexamethasone or 1000 mg prednisone.
  5. Central nervous system involvement.
  6. Uncontrolled heart disease, including congestive heart failure ( III-IV), uncontrolled angina pectoris, uncontrolled conduction abnormalities, acute diffuse infiltrative pulmonary disease, pericardial disease or myocardial infarction within 6 months prior to enrollment
  7. Uncontrolled hypertension or uncontrolled diabetes despite medication
  8. Active or C infection or known (HIV) positivity.
  9. Another active . Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
  10. Primary plasma cell leukemia, systemic AL amyloidosis, Waldenströms macroglobulinemia, POEMS syndrome
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    PET-CT-positive patients

    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

    Drug: Carfilzomib · Drug: Lenalidomide · Device: PET-CT · Drug: Dexamethasone

Interventions

06

What researchers measure

Primary outcomes

  1. PET negativity after induction

    How many of PET positive patients will become PET negative after treatment

    Time frame: 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.

    Time frame: 1 month after induction

07

Study locations

4 sites
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Nov 2021, 43 months.

Of 61 non-industry phase 2 interventional studies under Neoplasms, Plasma Cell, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 89. This study's 43 months is below that.

Counting every sponsor, half of 67 studies reached it within 58 months; a quarter within 38 and three quarters within 94.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 8, 2017
First posted
Oct 19, 2017
StartActual
Mar 16, 2018
Primary completionActual
Nov 1, 2021
CompletionEst.
Nov 1, 2026
Last update
Aug 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03314636
Collaborators
Nordic Myeloma Study Group
Responsible party
Fredrik Hellem Schjesvold (Head of Oslo Myeloma Center, Oslo University Hospital) — Principal investigator
First posted
Oct 19, 2017
Start date
Mar 16, 2018
Primary completion
Nov 1, 2021
Completion
Nov 1, 2026 (estimated)
Last update
Aug 8, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Carfilzomib

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