OPEN Research Support
head

Consultant Doctor
Thomas Lund
Department of Hematology, Odense University Hospital


Projekt styring
Projekt status    Sampling ongoing
 
Data indsamlingsdatoer
Start 01.01.2018  
Slut 30.06.2024  
 



Bone Healing During Ninlaro Exposure (BONE)

Short summary

The primary purpose of this study is to investigate if treatment with Ixazomib in multiple myeloma (MM) can strengthen the bones, thus making it resilient to future fractures. Ixazomib will be given at a time point when the disease is in a stable phase, decreasing the likelihood that the potential bone anabolic effect will be abrogated by catabolic effect of active MM. In order to be included in the study, the patient must have treatment demanding MM, and the disease must have been brought into at least partial remission with chemotherapy before inclusion. Moreover, the patient must have pathological bone structure on low dose CT due to the pre-existing disease. 


Rationale

Despite major advances in the treatment, MM remains an incurable, malignant disease. Most patients experience multiple relapses during their course of disease and will either die from accumulated organ deterioration or due to developed treatment resistance. The major cause of morbidity in MM is the bone destructions and excessive loss of bone mass observed throughout the disease. At diagnosis, sixty percent of the patients suffer from bone pain and eighty percent have pathological changes in the skeleton.

As a consequence, bone loss accumulates throughout each relapse, until the patient is unable to have a normal life. Bisphosphonates are used to treat the bone disease in MM, but these compounds, like anti-myeloma treatment, only reduce the excessive bone loss and do not affect the decreased bone formation.

Bone destruction in MM is common, and leads to severe pain, hypercalcemia, pathological fractures, vertebral collapses, possible spinal cord compression, and causes reduced quality of life and high morbidity. The primary purpose of this study is to investigate if treatment with Ixazomib in MM can strengthen the bones, thus making it resilient to future fractures. Ixazomib will be given at a time point when the disease is in a stable phase, decreasing the likelihood that the potential bone anabolic effect will be abrogated by catabolic effect of active MM. 


Description of the cohort

Thirty patients with MM in stable phase will be included in the study. Stable phase is defined by at least three a months period without anti-myeloma treatment where no increase in M-component or serum free light chain difference has been observed. Likewise, the patients must have responded to their last treatment with at least partial response. All patients must also have pre-existing osteolytic lesions (>5 mm) detectable in low dose CT. All patients will be invited to participate in the protocol if they meet the inclusion- and exclusion criteria. 


Data and biological material

No data will be collected about the patient before informed consent has been given from the patient. Data concerning civic registration number, age, gender, disease status, bone status, disease treatment, comorbidities, medication and lab samples will be collected from the medical journal. During the study, the patients will undergo extra examinations due to the trial.


Publications associated with the project

Department of Hematology, Odense University Hospital

  • MD, PhD Ass. Professor, Thomas Lund

Department of Hematology, Odense University Hospital 

  • MD, PhD Senior Registrar, Ida Bruun Kristensen 

Department of Hematology, Odense University Hospital

  • Professor MD, Niels Abildgaard 

Department of Hematology, Odense University Hospital

  • Professor MSc PhD, Charlotte Guldborg Nyvold