Objective of the studyThe present pilot study will be focused to define the sensitivity of SRS in MM patients and in patients with plasmacytoma. This in comparison to X-ray examination. In addition it will be investigated whether SRS can be used as…
ID
Source
Brief title
Condition
- Plasma cell neoplasms
- Haematopoietic neoplasms (excl leukaemias and lymphomas)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Study parameters
In this pilot study a limited number of patients will be analysed to define
whether SRS is a feasible approach for diagnostic or prognostic purposes in MM
or plasmacytoma. Thirty newly diagnosed upfront patients and 15 relapsed
patients will be investigated. In these patients the following items will be
investigated:
-To define the sensitivity of SRS in MM and plasmacytoma in comparison to X-ray
examination.
-To test whether SRS can be used as alternative approach to detect skeleton
abnormalities for painful affected areas in the case no abnormalities are
observed on X *ray examination.
-Correlates the SRS uptake with clinical parameters that defines an aggressive
MM and disappear the increased uptake upon treatment with intensive
chemotherapy and ASCT and or radiotherapy. Subsequently patients treated
according to the Hovon-65 protocol will be re-evaluated after 4 courses of
chemotherapy but before the ASCT. Patients with a plasmacytoma will be
re-evaluated 2 months after the radiotherapy course.
Secondary outcome
Not applicable.
Background summary
Multiple Myeloma
Multiple Myeloma (MM) is clonal B cell disorder characterised by a monoclonal
plasma cell population in bone marrow, with bone pain, hypercalceamia, and
kidney dysfunction as clinically presenting symptoms. In the majority of the
patients the disorder is disseminated through the bone marrow compartment but
in 5% of the patients MM presents as localized disorder i.e. a plasmacytoma.
The abnormalities of the skeleton can be identified by X-ray examination and
demonstrates frequently the characteristics osteolytic defects9. However, in
30%-40% of the patients no osteolytic defects can be demonstrated but only
osteoporosis. Post-treatment the X-ray abnormalities persist and no distinction
can be made at an early time point whether vital tumor cells are still present
or whether the skeleton abnormalities contain normal cells. Sofar only FDG-PET
has been used to study the metabolic activity of the malignant plasma
cells9-11. Several small studies have demonstrated that osteolytic lesions
might be FDG-PET positive due to their higher metabolic activity.
Different in vitro studies have demonstrated that the somatostatin receptor is
expressed on malignant plasma cells12-13. However, so far no clinical studies
have been published in MM with SRS. Especially in view of the high somatostatin
receptor expression it is conceivable that SRS might be a good alternative to
the study the presence of the malignant plasma cells. The whole body scan might
be of value to demonstrate whether a localized versus disseminated disorder is
present. Clinically this is an important question since patients with localized
disease are treated with high dose radiotherapy while patients with a
disseminated disorder are treated with intensive chemotherapy including
autologous stem cell transplantation14. An additionally value of this scanning
technique is that the degree of uptake can be quantified which might indirectly
be an indicator of the malignant character of the plasma cells as has been
demonstrated for FDG-PET in lymphoma patients. Patients with a high FDG-PET
uptake did have an aggressive lymphoma15.
Preliminary results in 4 MM or plasmacytoma patients demonstrated a high SRS
binding in some of the affected areas (histological proven) which normalized
after chemotherapy in two MM patients.
Based on these results it is of clinical relevance to study the value of SRS in
MM patients and to what extent it can be used as marker for localized or
disseminated disorder.
Study objective
Objective of the study
The present pilot study will be focused to define the sensitivity of SRS in MM
patients and in patients with plasmacytoma. This in comparison to X-ray
examination. In addition it will be investigated whether SRS can be used as an
alternative approach to detect skeleton abnormalities for painful affected
areas in the case no abnormalities on X-ray examination can be observed
including in patients with relapse MM. Bone pain is the most frequent symptom
in MM. Finally the SRS uptake will be quantified to demonstrate whether the
degree of uptake correlates with known prognostic scores and might disappear in
the case of responsive disease upon intensive chemotherapy and ASCT.
Study design
Study design
In patients with newly diagnosed MM or plasmacytoma SRS will be performed in
conjunction with the additional work-up that will be performed according to the
ongoing HOVON 49 and HOVON 65 studies or according to accepted international
guidelines9. In MM patients with painful affected area*s SRS will be performed
in conjunction with X-ray examination which might be extended with CT-scan or
MRI on basis of clinical indication.
Study burden and risks
- No specific risk
- The burden to visit the hospital and to undergo the scan.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
-Upfront patients with MM that are treated according to the HOVON-49 or HOVON-65 protocol.
-Upfront patients with plasmacytoma.
-Relapsed MM patients with painful affected areas.
Exclusion criteria
-Radiotherapy lasting longer than 5 days ago in the last 3 months.
-Ineligible to perform a scan.
-Age under 18 years.
-Pregnancy
-Severe kidney-dysfunction
Design
Recruitment
Medical products/devices used
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 |
---|---|
EudraCT | EUCTR2006-004737-14-NL |
CCMO | NL14066.042.06 |