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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2009 by Herlev Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272466
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Odense University Hospital
Information provided by:
Herlev Hospital
  Purpose
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.

Condition Intervention Phase
Relapsed Multiple Myeloma Biological: peptides derived from antiapoptotic proteins Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: 15 months ]

Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: peptides from antiapoptotic proteins Biological: peptides derived from antiapoptotic proteins
8 Vaccinations on day 2 and 9 in every bortezomib treatment series

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272466


Locations
Denmark
Department of Haematology, Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Lene M Knudsen, M.D.    +4565411850    lene.meldgaard.knudsen@ouh.regionsyddanmark.dk   
Contact: Niels Abildgaard, M.D.    +4523221584    niels.abildgaard@ouh.regionsyddanmark.dk   
Principal Investigator: Lene M Knudsen, M.D.         
Sponsors and Collaborators
Herlev Hospital
Odense University Hospital
Investigators
Principal Investigator: Lene M Knudsen, M.D Department of Haematology, Odense University Hospital
  More Information

Responsible Party: Lene Meldgaard Knudsen M.D. Head of Department, Department of Haematology, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01272466     History of Changes
Other Study ID Numbers: 2006-003619-29
First Submitted: January 3, 2011
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
Last Verified: May 2009

Keywords provided by Herlev Hospital:
multiple myeloma
vaccination
antiapoptotic proteins
proteasome inhibition

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Proteasome Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action