NCT00988312

Brief Summary

Patients with stage-I multiple myeloma are treated with a vaccine made from their own immune cells (dendritic cells) and their own myeloma protein. Vaccinations are given on 5 occasions every 4 weeks. The aim is to induce an immune reaction against the malignant myeloma cells in order to slow down or cure the disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Mar 2002

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

October 2, 2009

Status Verified

October 1, 2009

Enrollment Period

1.9 years

First QC Date

October 1, 2009

Last Update Submit

October 1, 2009

Conditions

Multiple MyelomaPlasmocytoma

Keywords

dendritic cells (DC)idiotype (Id)immunotherapy

Outcome Measures

Primary Outcomes (1)

  • Specific T-cell proliferation/cytokine secretion

Secondary Outcomes (4)

  • number of T cells

    pre and post vaccination

  • monoclonal protein

    pre and post vaccination

  • plasmacells in bone marrow

    pre and post vaccination

  • vital signs

    pre and post vaccination

Study Arms (2)

s.c. vaccination

EXPERIMENTAL

vaccine given subcutaneously

Biological: autologous idiotype-protein pulsed dendritic cells

i.v. vaccination

EXPERIMENTAL

vaccines are given intravenously

Biological: autologous idiotype-protein pulsed dendritic cells

Interventions

autologous idiotype-protein pulsed dendritic cellsBIOLOGICAL

Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks

i.v. vaccinations.c. vaccination

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • multiple myeloma
  • stage I (Salmon \& Durie)
  • no cytoreductive pre-treatment

You may not qualify if:

  • myeloma stages II-III
  • asecretory disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Multiple MyelomaPlasmacytoma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Susanne Gretzinger, MD

    University Hospital Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

March 1, 2002

Primary Completion

February 1, 2004

Study Completion

March 1, 2004

Last Updated

October 2, 2009

Record last verified: 2009-10

Locations

DE(1)