Short summary

Multiple myeloma is an incurable malignant haematologic disease of the plasma cells. The survival of myeloma has improved after introduction of high-dose melphalan with autologous stem cell support (HDT). The prognosis after relapse varies depending on the type of relapse and time to treatment failure from the primary HDT. Eligible patients with late relapse are considered for salvage HDT, but the data on the outcome of a second HDT are contradicting.

Quality of life during observation or maintenance with carfilzomib is a secondary end-point in the Nordic Myeloma Study Group protocol Phase II study of carfilzomib-cyclophosphamide-dexamethasone and high-dose melphalan followed by randomization between observation or maintenance with carfilzomib and dexamethasone in patients with relapsed multiple myeloma after high-dose melphalan with autologous stem cell support.

Rationale

The purpose of the study is to evaluate the effect of carfilzomib-cyclophosphamide-dexamethasone and high-dose melphalan followed by observation or maintenance with carfilzomib and dexamethasone in patients with relapse multiple myeloma after HDT.

Description of the cohort

200 patients with relapse more than one year after single or double high-dose melphalan with stem cell support. The patients will be recruited from participating clinics within the Nordic Myeloma Study Group. 

Data and biological material

After randomization to observation or carfilzomib and dexamethasone maintenance the patients will fill in the EORTC QLQ-C30 and MY20 questionnaire at baseline and repeating every 2. month during the study period. 

Collaborating researchers and departments

Department of Haematology, Aalborg University Hospital

• Sponsor and National Investigator Henrik Gregersen, MD, PhD

• National Investigator Markus Hansson, MD

Oslo Universitetssjukhus, Rikshospitalet, Norway

• Senior Consultant and National Investigator Nina Gulbrandsen

Turku Uniersity Hospital, Finland

• National Investigator Kari Remes, MD

Vilnius University Hospital, Lithuania

• National Investigator Vildas Peceliunas, MD