Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma

Anti-apoptotic proteins from the Bcl-2 family are known to play a key role in oncogenesis and are overexpressed in myeloma cells. Studies have shown that dendritic cells exposed to proteasome inhibition present exogene antigens better than unexposed dendritic cells. Patients with relapse of multiple myeloma will be offered vaccination with peptides derived from antiapoptotic proteins from the Bcl-2 family in combination with an immunostimulatory adjuvant. The vaccination will be given in relation to treatment with the proteasome inhibitor bortezomib.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Department of Haematology, Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

clinical diagnosis of multiple myeloma
tissue type of HLA-A1, HLA-A2 or HLA-A3
Performance status < 2
Adequate bone marrow - renal and liver function
written informed concent

Exclusion criteria

candidate for bone marrow transplantation
other malignancies than multiple myeloma
other significant medical disease (heart-, lung or liver disease or diabetes)
allergy
active autoimmune disease
treatment with immunosuppressive drugs
treatment with other experimental drugs
uncontrolled hypercalcemia

Treatment and study plan

peptides derived from antiapoptotic proteins

Biological

8 Vaccinations on day 2 and 9 in every bortezomib treatment series

Primary outcomes

Number of participants with adverse events

Time frame: 15 months

Sponsors and collaborators

Lead sponsor

Herlev Hospital

Other

Collaborators

Odense University Hospital

Registry information

Official study title

Vaccination With Peptides Derived From Anti-apoptotic Proteins From the Bcl-2 Family, Administered in Combination With Montanide ISA-51 in Relation to Treatment With Proteasome Inhibitors in Patients With Relapsed Multiple Myeloma

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2015
First posted: Jan 7, 2011
Registry last updated: Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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