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

NCT ID: NCT01272466

Last Updated: 2018-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2015-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Relapsed Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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peptides from antiapoptotic proteins

Group Type EXPERIMENTAL

peptides derived from antiapoptotic proteins

Intervention Type BIOLOGICAL

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

Interventions

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peptides derived from antiapoptotic proteins

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lene Meldgaard Knudsen

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lene M Knudsen, M.D

Role: PRINCIPAL_INVESTIGATOR

Department of Haematology, Odense University Hospital

Locations

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Department of Haematology, Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2006-003619-29

Identifier Type: -

Identifier Source: org_study_id

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