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

Primary Purpose

Relapsed Multiple Myeloma

Status

Completed

Phase

Phase 1

Locations

Denmark

Study Type

Interventional

Intervention

peptides derived from antiapoptotic proteins

About this trial

This is an interventional treatment trial for Relapsed Multiple Myeloma focused on measuring multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Haematology, Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

peptides from antiapoptotic proteins

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Secondary Outcome Measures

Full Information

NCT ID

NCT01272466

First Posted

January 3, 2011

Last Updated

August 30, 2018

Sponsor

Herlev Hospital

Collaborators

Odense University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01272466

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

January 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herlev Hospital

Collaborators

Odense University Hospital

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsed Multiple Myeloma

Keywords

multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

peptides from antiapoptotic proteins

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

peptides derived from antiapoptotic proteins

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

15 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lene M Knudsen, M.D

Organizational Affiliation

Department of Haematology, Odense University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Haematology, Odense University Hospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

12. IPD Sharing Statement

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

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