Prognostic value of bone disease in MM, an evaluation of different imaging techniques at diagnosis and in follow-up.
Recruiting
- Conditions
- multiple myelomaelderly (>65 years)FDG-PETMRICTX-raydiagnosisfollow-up
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
1. Inclusion in the HOVON 87 study;
2. To be included in part II, patients have to participate in part I of the study.
Exclusion Criteria
1. Contraindications for MRI (including e.g. pacemaker, ICD, metallic splinter in eye, hemostatic clips in CNS, claustrofobia, or other implants that are contraindicated according to the MRI operator’s discretion);
2. Physical inability to access either MRI or PET-CT facilities;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Progression free survival, defined as time from registration to progression or death from any cause [part I only];<br /><br>2. Conversion rate, defined as complete normalization, of FDG-PET [part II only].
- Secondary Outcome Measures
Name Time Method 1. Clinically symptomatic bone disease defined as fractures and lesions needing radiotherapy and/or surgery;<br /><br>2. Clinically symptomatic bone disease defined by the EORTC QLQ-MY20 measuring specific aspects of multiple myeloma, i.e. specific pain complaints;<br /><br>3. Overall survival, measured from time of registration;<br /><br>4. Conversion rate, defined as complete normalization, of WB-MRI and contrast-enhanced MRI and diffusion-weighted MRI [part II only];<br /><br>5. The number and distribution of lesions detected by the different imaging techniques (at different time points [part II only]);<br /><br>6. Remission status as determined by the IMWG criteria after three induction cycles and after completion of induction therapy [part II only].