Prognostic value of bone disease in MM, an evaluation of different imaging techniques at diagnosis and in follow-up.

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).

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27317

Enrollment

Registered

2010-05-14

Start date

2010-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

multiple myeloma elderly (>65 years) FDG-PET MRI CT X-ray diagnosis follow-up

Interventions

1. FDG-PET-CT before treatment (60 patients) in follow up after 3th and 9th chemotherapy cycle (30 patients)

2. MRI before treatment (60 patients) in follow up after 3th and 9th chemotherapy cycle (30 patients)

3. Questionnaires before treatment (60 patients) in follow up after 3th and 9th chemotherapy cycle (30 patients)

4. OPG, sRANKL and DKK-1 before treatment in follow up after 3th and 9th chemotherapy cycle .

Eligibility

Inclusion criteria

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

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; 3. Active, uncontrolled infections; 4. Known or suspected hypersensitivity or intolerance to used contrast agent; 5. Impaired renal function: clearance ≤ 40 ml-min; 6. Uncontrolled diabetes; 7. Contraindications for (horizontal) immobilization during at least one hour [part II only].

Design outcomes

Primary

Measure	Time frame
1. Progression free survival, defined as time from registration to progression or death from any cause [part I only]; 2. Conversion rate, defined as complete normalization, of FDG-PET [part II only].	—

Secondary

Measure	Time frame
1. Clinically symptomatic bone disease defined as fractures and lesions needing radiotherapy and/or surgery; 2. Clinically symptomatic bone disease defined by the EORTC QLQ-MY20 measuring specific aspects of multiple myeloma, i.e. specific pain complaints; 3. Overall survival, measured from time of registration; 4. Conversion rate, defined as complete normalization, of WB-MRI and contrast-enhanced MRI and diffusion-weighted MRI [part II only]; 5. The number and distribution of lesions detected by the different imaging techniques (at different time points [part II only]); 6. Remission status as determined by the IMWG criteria after three induction cycles and after completion of induction therapy [part II only].	—

Measure

Time frame

1. Clinically symptomatic bone disease defined as fractures and lesions needing radiotherapy and/or surgery; 2. Clinically symptomatic bone disease defined by the EORTC QLQ-MY20 measuring specific aspects of multiple myeloma, i.e. specific pain complaints; 3. Overall survival, measured from time of registration; 4. Conversion rate, defined as complete normalization, of WB-MRI and contrast-enhanced MRI and diffusion-weighted MRI [part II only]; 5. The number and distribution of lesions detected by the different imaging techniques (at different time points [part II only]); 6. Remission status as determined by the IMWG criteria after three induction cycles and after completion of induction therapy [part II only].

—

Contacts

Public ContactJ.C. Regelink

De Boelelaan 1117

j.regelink@vumc.nl+31 (0)20 4442604

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)