Assessment of the prognostic value of MM related bone disease as detected by Whole Body X Ray (WBXR), Whole Body - Magnetic Resonance Imaging (WB-MRI) and FluoroDeoxyGlucose - Positron Emission Tomography - Computer Tomography (FDG-PET-CT) at diagnosis (part I) and in follow-up (part II)

Completed

Conditions: Kahler's disease
Multiple Myeloma
10035227

Registration Number: NL-OMON36434

Lead Sponsor: HOVO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Inclusion in the HOVON 87 study, concerning previously untreated patients with symptomatic multiple myeloma, age >65 or younger and ineligible for high dose therapy and peripheral stem cell transplantation.
To be included in part II, patients have to participate in part I of the study

Exclusion Criteria

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)
Physical inability to access either MRI or PET-CT facilities
Active, uncontrolled infections
Known or suspected hypersensitivity or intolerance to used contrast agents
Uncontrolled diabetes
Contraindications for (horizontal) immobilization during at least one hour [part II only]

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression free survival, defined as time from registration to progression or<br /><br>death from any cause [part I only]<br /><br><br /><br>Conversion rate, defined as complete normalization, of FDG-PET-CT and MRI [part<br /><br>II only]</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinically symptomatic bone disease defined as fractures and lesions needing<br /><br>radiotherapy and/or surgery<br /><br><br /><br>Clinically symptomatic bone disease defined by the EORTC QLQ-MY20 measuring<br /><br>specific aspects of multiple myeloma, i.e. specific pain complaints.<br /><br><br /><br>Overall survival, measured from time of registration<br /><br><br /><br>The number and distribution of lesions detected by the different imaging<br /><br>techniques (at different time points [part II only])<br /><br><br /><br>Remission status as determined by the IMWG criteria after three induction<br /><br>cycles and after completion of induction therapy [part II only]</p><br>