Evaluation of bone marrow hypoxia with 18F-FAZA PET in patients with relapsing multiple myeloma; a pilot study

Withdrawn

• Conditions: Multiple myeloma and Kahler's disease; 10035227; 10005959

• Registration Number: NL-OMON35390
• Lead Sponsor: Hematologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Patient with a positive FDG-PET scan.
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 remission
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>Feasibility of 18F-FAZA scans in patients with relapsing multiple myeloma. In<br /><br>addition bone marrow staining to demonstrate whether hypoxia related proteins<br /><br>are upregulated by plasma cells or surrounding cells including HIF 1a , HIF2a ,<br /><br>GLUT-1 and -3 and VEGF.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable.</p><br>