OPEN Research Support
head

Project manager
Henrik Sunne Eshøj
Department of Hematology, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.11.2017  
Slut 31.12.2020  
 



Quality of life during KRd consolidation in myeloma patients with a positive PET-CT after standard first line treatment. A phase II study (the CONPET trial)

Short summary

Multiple myeloma patients that are PET-CT positive after first-line therapy receive four 28-day cycles of Carfilzomib-Revlimid-Dexamethason (KRd) consolidation, before a new PET-CT is performed. The objectives are to assess the proportion of patients that are PET-positive after standard first line treatment, and how many of these can become PET-negative after four 28-day cycles of KRd treatment. Secondary objectives are to determine the effects of KRd on health-related quality of life, shortness of breath and peripheral neuropathy.


Rationale

Multiple Myeloma (MM) is the most common hematological malignancy after lymphoms. The overall survival (OS) of patients has doubled in the last 30 years from a median of 2-3 years to 4-6 years in elderly patients, and up to 8-10 years for younger patients, due to autologous stem cell transplantation (ASCT) combined with immunomodulatory drugs and proteasome inhibitors. However, after first-line therapy, most patients experience several relapses in the course of the disease. Time to first relapse is an important predictor for overall survival. It has been shown, that PET-CT before maintenance after first-line treatment is the best predictor for OS. Patients with PET-CT positivity are therefore the focus of this study. The primary question to be answered is whether four 28-days cycles of KRd consolidation can turn PET-CT positivity into negativity.

A secondary objective is to document the health-related quality of life during and after consolidation with KRd. It has been shown that toxicity and side effects from cancer-related treatments are underreported by medical doctors and health care givers. One way to address this is to collect data directly from patients themselves. This is achieved using patient reported outcomes (PRO). Generally, there is a lack of studies collecting PRO data from patients treated with KRd. Based on common side effects and empirical knowledge from clinical practice, special interest in this study will be on shortness of breath and peripheral neuropathy.  


Description of the cohort

50 multiple myeloma patients with PET-CT positivity after standard first line therapy are included from five Nordic Hematological departments at Oslo (No), Lund (Se), Copenhagen (Rigshospitalet) (Dk), Odense (Dk) and Vejle (Dk). All centers are part of the Nordic Myeloma Study Group (NMSG). 


Data and biological material

PRO data  (European Organization for research and treatment of cancer (EORTC) core questionnaire (QLQ-C30), The Pulmonary Symptom Index (PSI) and Chemotherapy-Induced Peripheral Neuropathy (CIPN-20)) are collected at day 1 (baseline) and day 15 in each cycle besides one and three months after end of KRd consolidation, and at end of treatment (progressive disease). PRO data are collected electronically. 


Collaborating researchers and departments

Department of Haematology , Oslo Universitetssjukhus, Rikshospitalet, Norway

  • Sponsor and National Investigator, Fredrik Schjesvold, MD, PhD

Department of Haematology, Odense University Hospital, Denmark 

  • Professor Niels Abildgaard, MD, PhD

Department of Haematology,  Rigshospitalet, Copenhagen 

  • Clinical Assoaciate Professor Annette Vangsted, MD, PhD

Department of Haematology, Skåne University Hospital, Sweden

  • Associate Professor Markus Hansson, MD, PhD

Department of Haematology, Hospital Lillebaelt, Vejle, Denmark 

  • Professor Torben Plesner, MD, PhD