Primary objective: To assess the prognostic value of MM related bone disease as detected by WBXR, WB-MRI and FDG-PET-CT in terms of progression free survival. To determine the conversion rate, defined as complete normalization, of FDG-PET-CT, after…
ID
Source
Brief title
Condition
- Plasma cell neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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]
Background summary
Bone disease is common in patients with symptomatic/stage III Multiple Myeloma
(MM), with up to 90% of patients developing bone lesions, which causes major
morbidity.
Routinely, conventional 'whole body X-ray' (WBXR) analysis is used to evaluate
and asses the presence of bone disease. The sensitivity, however, is low
compared to newer imaging technieques: MRI and (FDG-PET-)CT. Although the
negative prognostic impact of the presence of bone lesions as detected by WBXR
is clear and has been validated, there is less information on the prognostic
value of the newer imaging techniques. Thus, to date, replacement of WBXR by
one of the newer imaging techniques is not possible.
Currently evaluation of treatment is performed according to the IMWG criteria,
using m-protein and clonal plasma cell count only. Evaluation of bone disease
is not possible, since signs of MM related bone disease detected with WBXR will
not disappear. Therefore remission cannot be judged by using WBXR. Earlier
results show the value of the newer imaging techniques in follow up. Although
especially FDG-PET-CT seems suitable it is not completely clear which one of
the newer imaging techniques will be the most important in treatment
evaluation.
A relation between the extent of bone disease and biological markers of bone
disease and gene expression profiling has been demonstrated. It is however not
yet clear which one of the imaging techniques shows the best correlation.
Study objective
Primary objective:
To assess the prognostic value of MM related bone disease as detected by WBXR,
WB-MRI and FDG-PET-CT in terms of progression free survival.
To determine the conversion rate, defined as complete normalization, of
FDG-PET-CT, after 3 cycles and completion of therapy [part II only]
Secondary objectives:
To asses the prognostic value of MM related bone disease as detected by WBXR,
WB-MRI and FDG-PET-CT in terms of clinically symptomatic bone disease
To asses the prognostic value of MM related bone disease as detected by WBXR,
WB-MRI and FDG-PET-CT in terms of overall survival
To compare the number and distribution of lesions detected by WBXR, WB-MRI and
FDG-PET-CT.
To assess the relation between the extent of MM related bone disease detected
by WBXR, WB-MRI and FDG-PET-CT and biological features of MM bone disease as
determined by DKK1 levels, sRANKL and osteoprotegerin.
To investigate distinct patterns of gene expression involved in MM related bone
disease
To determine the conversion rate, defined as complete normalization, of MRI,
after 3 cycles and completion of therapy [part II only]
To compare the response rate as determined by imaging techniques with classical
response monitoring according to IMWG [part II only]
To assess and compare the prognostic value of mid- and post-treatment remission
status as determined with imaging techniques and classical response monitoring
in terms of PFS and OS [part II only]
To compare *classical* MRI with contrast-enhanced MRI and diffusion-weighted
MRI with respect to focal lesions and diffuse infiltration by multiple myeloma
[part II only]
Study design
Side study of HOVON 87
Study burden and risks
There is a burden of time: every scan takes 30 to 60 minutes. Thus, concerning
patients participating in part II performing all scans will take 3 to 6 hours.
Patients will be asked to fill in questionnaires. These forms will be send to
with the HOVON 87 questionnaires.
PO box 5201
3008AE Rotterdam
NL
PO box 5201
3008AE Rotterdam
NL
Listed location countries
Age
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]
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL30387.029.10 |