NCT03314636

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Carfilzomib	See in arm description
DRUG	Lenalidomide	See in arm description
DEVICE	PET-CT	See in arm description
DRUG	Dexamethasone	See in arm description

Timeline

• Start date: 2018-03-16
• Primary completion: 2021-11-01
• Completion: 2026-11-01
• First posted: 2017-10-19
• Last updated: 2025-08-08

Locations

4 sites across 3 countries: Denmark, Norway, Sweden