OPEN Research Support
head

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


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.03.2018  
Slut 31.12.2023  
 



Patient Reported Outcome and Quality of Life in newly diagnosed transplant eligible multiple myeloma patients treated with ixazomib, lenalidomide plus dexamethasone (IRd-study)

Short summary

In the Nordic countries about 400 upfront Autologous stem cell transplantations are performed every year in patients with multiple myeloma. However, since ASCT is not a curative treatment, post-ASCT therapy are widely investigated to improve the depth of response and to achieve sustained long-term response. This study aim to determine the treatment effects of ixazomib, lenalidomide and dexamethasone (IRd) combination on patient reported outcomes (PROs) in newly diagnosed transplant eligible multiple myeloma patients. 


Rationale

Multiple myeloma (MM) is the most common hematological malignancy after lymphomas and is considered a chronic, incurable cancer disease. Further, MM patients with high-risk chromosomal findings (cytogenic aberrations) at the time of diagnose have an estimated median overall survival of only two years. Therefore, new drugs and therapeutic innovations are urgently needed to improve the depth of response and to achieve sustained long-term response. This study aims to explore the effect of four 28-day induction cycles therapy, followed by autologous stem cell transplantation and two 28-days consolidation cycles therapy. Hereafter, a risk based maintenance therapy, according to the patients cytogenic status at the time of diagnosis (high- or low-risk profiles), is used. In the current study, a new treatment approach for high-risk patients in maintenance therapy is tested (lenalidomide in combination with ixazomib). The primary endpoint in this phase II trial is to investigate the treatment efficacy on minimal residual disease as evaluated by flow-cytometry. Secondary objectives, which this project description particularly deals with, are to determine the effects of ixazomib, lenalidomide and dexamethasone on health-related patient reported outcomes (PROs) throughout the various treatment phases. The PROs cover scales on physical function, symptoms, global health, myeloma specific questions and peripheral neuropathy. 


Description of the cohort

120 newly diagnosed transplant eligible patients with multiple myeloma, age between 18 and 70 years. Patients are included from hematological departments at university hospitals in Finland, Lithuania, Norway and Sweden. All centers are part of the Nordic Myeloma Study Group (NMSG). 


Data and biological material

Treatment schedule:

Patients receive four IRd cycles of 28 day each as induction consists of ixazomib 4 mg on days 1, 8 and 15 and lenalidomide 25 mg on days 1-21 and dexamethasone 40 mg on days 1, 8, 15 and 22. After ASCT patients receive 2 consolidation cycles with the same combination as during induction. This is followed by risk stratified maintenance therapy (based on cytogenic Fluorence In Situ Hybridization (FISH) findings at diagnose) so that high-risk patients receive ixazomib plus lenalidomide maintenance and standard-low risk patients lenalidomide alone. The treatment will continue until progression or excess toxicity

Patient reported outcome (PRO) data collection:

PRO data are collected through the European Organization for Research and Treatment of Cancer (EORTC) questionnaires QLQ-C30, QLQ-MY20 (myeloma specific) and QLQ-CIPN20 (neuropathy specific) at induction, day 1 (baseline) and 15 in cycle 1 and 4, respectively. Then, day one of stem cell harvest, day 1 and 15 in cycle 1 and 2 of consolidation therapy followed by maintenance therapy with PRO assessment at day 1 and every three months until last PRO follow-up at 24 months.



Collaborating researchers and departments

Comprehensive Cancer Center Hematology, Helsinki University Hospital

  • MD, Raija Silvennoinen, PhD

Central Finland Central Hospital, Jyväskylä, Finland

  • MD, Anu Sikiö, 

Kymenlaakso Central Hospital, Kotka, Finland

  • MD, Anu Räsänen, 

Kainuu Central Hospital, Kajaani, Finland

Kuopio University Hospital, Kuopio, Finland

  • MD, Anu Partanen    

Päijät-Häme Central Hospital, Lahti, Finland

Oulu University Hospital, Oulu, Finland

  • MD, Marjaana Säily, PhD      

Tampere University Hospital, Tampere, Finland

Turku University Hospital, Turku, Finland

Vilnius University Hospital, Vilnius, Lithuania

Forde Central Hospital South, Forde, Norway

Oslo University Hospital, Oslo, Norway

Stavanger University Hospital, Stavanger, Norway

Trondheim University Hospital, Trondheim, Norway

Borås University Hospital, Borås, Sweden

  • MD, Ulf-Henrik Mellqvist   

Göteborg University Hospital, Göteborg, Sweden

  • MD, Cecilie Blimark

Halmstad Hospital Region Halland, Halmstad, Sweden

  • MD, Conny Karlsson      

Linköping University Hospital, Linköping, Sweden

  • MD, Lucia Ahlberg

Sunderby Hospital Region Norrbotten, Luleå, Sweden

  • MD, Birgitta Lauri

Lund University Hospital, Lund, Sweden

Helsingborg Hospital Skane, Skane, Sweden

  • MD, Per Axelsson

Karolinska University Hospital, Stockholm, Sweden

Uddevalla Hospital,Uddevalla, Sweden

  • MD, Johanna Abelsson  

Uppsala University Hospital, Uppsala, Sweden

  • MD, Kristina Carlson    

Varberg Hospital, Varberg, Sweden

  • MD, Mikael Olsson

Örebro University Hospital, Örebro, Sweden

  • MD, Olle Linder