89Zr-bevacizumab PET Scan in Patients With Relapsing Multiple Myeloma

NCT01859234 | Unknown

• 1 other identifier: UMCGABR40641
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see whether 89Zr-bevacizumab PET scanning is feasible in relapsing multiple myeloma patients.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; PET scan

Outcome Measures

Primary Outcomes (1)

• Focal lesion of 89Zr-bevacizumab PET scanning in patients with relapsing multiple myeloma

  We assume focal lesion will be feasible with 89Zr-bevacizumab PET scanning in patients with relapsing multiple myeloma. For each 89Zr-bevacizumab PET scan the amount of focal lesion and the localisation will be reported. When there is diffuse bone marrow uptake this will also be reported. The focal lesion found on the 89Zr-bevacizumab PET scan will be compared with focal lesions found on the FDG-PET scan. Furthermore the amount of focal lesion will be compared with the expression of VEGF, MVD, HIF 1 alpha and 2 alpha and GLUT 1 and 3.

  during scanning

Study Arms (1)

89Zr-bevacizumab PET scan

EXPERIMENTAL

all patients included in the study will have a 89Zr-bevacizumab PET scan

Drug: 89Zr-bevacizumab

Interventions

89Zr-bevacizumab DRUG

89Zr-bevacizumab will only be given once, prior for the PET scan. 5 mg will be given iv.

Also known as: Bevacizumab Roche registration limited eu/1/04/300/001, 89Zr-bevacizumab ATC code L01XC07

89Zr-bevacizumab PET scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsing multiple myeloma according to international defined guidelines:
• Relapse after having achieved complete remission:
• Reappearance of paraprotein
• More than 5% plasma cells in bone marrow.
• New lytic lesions or progression of old lesions.
• New hypercalcaeamia.
• Relapse after having achieved partial remission
• Increases of paraprotein with more than 25%
• Increase of urine paraprotein with more than 25%
• Increase of plasma cells in bone marrow with 10%
• New lytic lesions or progression of old lesions
• New hypercalcaemia -

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, Provincie Groningen, 9713GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

89Zr-bevacizumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

E G de Waal, MD

CONTACT

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

E vellenga, PhD/MD

CONTACT

+31503612354; e.vellenga@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hematologist

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

NL (1)