Evaluation of VEGF expression with 89Zr-bevacizumab PET scan in patients with relapsing multiple myeloma; a feasibility study.

Completed

Conditions: Multiple myeloma AND Kahler's disease
10035227
10005959

Registration Number: NL-OMON37271

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Patients with relapsing multiple myeloma according to international defined guidelines:;Relapse after having achieved complete remission:
1. Reappearance of paraprotein
2. More than 5% plasma cells in bone marrow.
3. New lytic lesions or progression of old lesions.
4. New hypercalceamia.;Relapse after having achieved partial remsission
1. Increases of paraprotein with more than 25%
2. Increase of urine paraprotein with more than 25%
3. Increase of plasma cells in bone marrow with 10%
4. New lytic lesions or progression of old lesions
5. New hypercalceamia

Exclusion Criteria

- Radiotherapy in the last 3 months.
- Ineligible to lay supine during the PET scan.
- Age <=18 years.
- Pregnancy.
- Claustrophobia
- Severe kidney dysfunction; serum-creatinine >=250 µM

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint will be 89Zr-bevacizumab tracer uptake in multiple myeloma<br /><br>lesions</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints will be:<br /><br>• The correlation between positive lesions found on the FDG-PET and lesions<br /><br>found on 89Zr-bevacizumab PET scan.<br /><br>• The correlation between VEGF levels and MVD in bone marrow samples of MM<br /><br>patients and lesions found on 89Zr-bevacizumab PET scan.</p><br>