Evaluation of protein expression with labeled-bevacizumab scan in patients with relapsing multiple myeloma.

• Conditions: patients with relapsing multiple myeloma; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002335-28-NL
• Lead Sponsor: niversity medical centre groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-10
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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: Interventional clinical trial of medicinal product
• Study Design: Not specified