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)

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) - Prognostic value of MM bone disease detected by 3 imaging techniques

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36434

Enrollment

Registered

2010-04-13

Start date

2010-06-21

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kahler's disease Multiple Myeloma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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]

Design outcomes

Primary

Measure	Time frame
Progression free survival, defined as time from registration to progression or death from any cause [part I only] Conversion rate, defined as complete normalization, of FDG-PET-CT and MRI [part II only]	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results