Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03314636

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Carfilzomib

Drug

See in arm description

Lenalidomide

Drug

See in arm description

PET-CT

Device

See in arm description

Dexamethasone

Drug

See in arm description

Primary outcomes

  1. PET negativity after induction

    Time frame: 1 month after induction

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

Secondary outcomes

  1. PET correlation with MRD Euroflow

    Time frame: 1 month after induction

    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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Nordic Myeloma Study Group

Registry information

Official study title

KRd Consolidation in Myeloma Patients With a Positive PET-CT After Standard First Line Treatment. A Phase II Study

Acronym: CONPET

Important dates

Study start
2018
Primary completion
2021
Study completion
2026
First posted
Oct 19, 2017
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.