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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002335-28-NL

Enrollment

Registered

2012-07-10

Start date

2013-01-07

Completion date

Unknown

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with relapsing multiple myeloma

Interventions

Product Name: 89Zr-bevacizumab Pharmaceutical Form: Solution for infusion INN or Proposed INN: not applicable CAS Number: none Current Sponsor code: not applicable Other descriptive name: 89-Zr-sucDf-

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: In the present study we will perform a feasibility study to demonstrate that VEGF PET imaging by using 89Zr-bevacizumab as tracer can be used to detect multiple myeloma lesions;Secondary Objective: the comparison of 89Zr-bevacizumab PET imaging with the FDG-PET scan to demonstrate whether increased angiogenesis is associated with enhanced FDG uptake. Furthermore bone marrow material will be stained to for micro vessel density (MVD) and VEGF levels. In addition we will see if there is a correlation between lesion found on the 89Zr-bevacizumab PET scan and expression of VEGF and MVD.;Primary end point(s): 89Zr-bevacizumab tracer uptake in multiple myeloma lesions;Timepoint(s) of evaluation of this end point: 89Zr-bevacizumab tracer uptake in multiple myeloma lesions	—

Measure

Time frame

Main Objective: In the present study we will perform a feasibility study to demonstrate that VEGF PET imaging by using 89Zr-bevacizumab as tracer can be used to detect multiple myeloma lesions;Secondary Objective: the comparison of 89Zr-bevacizumab PET imaging with the FDG-PET scan to demonstrate whether increased angiogenesis is associated with enhanced FDG uptake. Furthermore bone marrow material will be stained to for micro vessel density (MVD) and VEGF levels. In addition we will see if there is a correlation between lesion found on the 89Zr-bevacizumab PET scan and expression of VEGF and MVD.;Primary end point(s): 89Zr-bevacizumab tracer uptake in multiple myeloma lesions;Timepoint(s) of evaluation of this end point: 89Zr-bevacizumab tracer uptake in multiple myeloma lesions

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Secondary

Measure	Time frame
Secondary end point(s): • The correlation between positive lesions found on the FDG-PET and lesions found on 89Zr-bevacizumab PET. • The correlation between VEGF levels and MVD in bone marrow samples of multiple myeloma patients and lesions found on 89Zr-bevacizumab PET. ;Timepoint(s) of evaluation of this end point: The scans and bone marrow samples will be evaluated directly (after they are peformed).	—

Measure

Time frame

Secondary end point(s): • The correlation between positive lesions found on the FDG-PET and lesions found on 89Zr-bevacizumab PET. • The correlation between VEGF levels and MVD in bone marrow samples of multiple myeloma patients and lesions found on 89Zr-bevacizumab PET. ;Timepoint(s) of evaluation of this end point: The scans and bone marrow samples will be evaluated directly (after they are peformed).

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Countries

Netherlands

Contacts

Public ContactDepartment of hematology

University medical centre groningen

e.g.m.de.waal@umcg.nl+31503612354

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026