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

NCT03314636 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: NMSG25/16
• Study Type: interventional
• Target: 53
• Locations: 3 countries
• Sites: 4

Brief 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.

Conditions

Myeloma

Outcome Measures

Primary Outcomes (1)

• PET negativity after induction

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

  1 month after induction

Secondary Outcomes (1)

• PET correlation with MRD Euroflow

  1 month after induction

Study Arms (1)

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

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

Interventions

Carfilzomib DRUG

See in arm description

PET-CT-positive patients

Lenalidomide DRUG

See in arm description

PET-CT-positive patients

PET-CT DEVICE

See in arm description

PET-CT-positive patients

Dexamethasone DRUG

See in arm description

PET-CT-positive patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Nordic Myeloma Study Group: collaborator

Study Sites (4)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Oslo University Hospital

Oslo, Norway

Location

Skåne University Hospital

Lund, Sweden

Location

Related Publications (1)

• 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.

  PMID: 39638553 DERIVED

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Interventions

carfilzomib; Lenalidomide; Positron Emission Tomography Computed Tomography; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Oslo Myeloma Center

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: October 19, 2017
• Study Start: March 16, 2018
• Primary Completion: November 1, 2021
• Study Completion (Estimated): November 1, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1); DK (2); NO (1)