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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Herlev Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Odense University Hospital
Information provided by:
Herlev Hospital
ClinicalTrials.gov Identifier:
NCT01272466
First received: January 3, 2011
Last updated: January 6, 2011
Last verified: May 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 3, 2011
Last Updated: January 6, 2011
Health Authority: Denmark: Danish Medicines Agency
Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014