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

• Sponsor: Herlev Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01272466
• Collaborator: Odense University Hospital (Other)
• Enrollment: 40
• Location: 1
• Arm: 1
• Duration (Months): 59
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Relapsed Multiple Myeloma	Biological: peptides derived from antiapoptotic proteins	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• 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
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: peptides from antiapoptotic proteins	Biological: peptides derived from antiapoptotic proteins; 8 Vaccinations on day 2 and 9 in every bortezomib treatment series

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events [15 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Haematology, Odense University Hospital	Odense		Denmark	5000

Sponsors and Collaborators

• Herlev Hospital
• Odense University Hospital

Investigators

• Principal Investigator: Lene M Knudsen, M.D, Department of Haematology, Odense University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lene Meldgaard Knudsen, M.D, Herlev Hospital
• ClinicalTrials.gov Identifier: NCT01272466
• Other Study ID Numbers: 2006-003619-29
• First Posted: Jan 7, 2011
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Lene Meldgaard Knudsen, M.D, Herlev Hospital: multiple myeloma; vaccination; antiapoptotic proteins; proteasome inhibition
• Additional relevant MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell

Study Results

No Results Posted as of Aug 31, 2018