Multiple MyelomaPhase 1NCT00988312
Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma
A Phase 1 study testing autologous idiotype-protein pulsed dendritic cells in people with Multiple Myeloma and Plasmocytoma, run by University Hospital Carl Gustav Carus at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma, Plasmocytoma
- What is being tested?
- autologous idiotype-protein pulsed dendritic cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2002to Mar 2004
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- multiple myeloma
- stage I (Salmon \& Durie)
- no cytoreductive pre-treatment
Who cannot join
- myeloma stages II-III
- asecretory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma
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.
- Conditions
- Multiple Myeloma, Plasmocytoma
- Being tested
- autologous idiotype-protein pulsed dendritic cells
- Keywords
- dendritic cells (DC), idiotype (Id), immunotherapy
- Medical subject headings
- Multiple Myeloma, Plasmacytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous idiotype-protein pulsed dendritic cellsBiological
Vaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| s.c. vaccination | Experimental | vaccine given subcutaneously Receives: Biological: autologous idiotype-protein pulsed dendritic cells |
| i.v. vaccination | Experimental | vaccines are given intravenously Receives: Biological: autologous idiotype-protein pulsed dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specific T-cell proliferation/cytokine secretion
Secondary outcomes (4)
number of T cells
Measured: pre and post vaccination
monoclonal protein
Measured: pre and post vaccination
plasmacells in bone marrow
Measured: pre and post vaccination
vital signs
Measured: pre and post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startMar 2002
- Primary completionFeb 2004
- Study completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Carl Gustav Carus
- Sponsor type
- University, hospital or other
- Investigators
- Susanne Gretzinger, MD, Principal investigator, University Hospital Dresden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988312
- Sponsor's protocol ID
- MyelomVak
- Status last verified
- Oct 2009
- First submitted
- 1 Oct 2009
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination With Idiotype-KLH Loaded Dendritic Cells. A Phase I Study for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00988312
- Acronym / sponsor ID
- MyelomVak
- Conditions
- Multiple Myeloma, Plasmocytoma
- Keywords
- dendritic cells (DC), idiotype (Id), immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital Carl Gustav CarusUniversity, hospital or other
- Study start
- Mar 2002
- Primary completion
- Feb 2004 (actual)
- Study completion
- Mar 2004 (actual)
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| s.c. vaccination | Experimental | Biological: autologous idiotype-protein pulsed dendritic cellsvaccine given subcutaneously |
| i.v. vaccination | Experimental | Biological: autologous idiotype-protein pulsed dendritic cellsvaccines are given intravenously |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- multiple myeloma
- stage I (Salmon \& Durie)
- no cytoreductive pre-treatment
Key exclusion criteria (2 listed)
- myeloma stages II-III
- asecretory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous idiotype-protein pulsed dendritic cellsVaccination with autologous idiotype-protein pulsed dendritic cells on 5 occasions every 4 weeks | Biological | i.v. vaccination, s.c. vaccination |
Primary outcome
Specific T-cell proliferation/cytokine secretion
4 secondary outcomes
number of T cells
Time frame: pre and post vaccination
monoclonal protein
Time frame: pre and post vaccination
plasmacells in bone marrow
Time frame: pre and post vaccination
vital signs
Time frame: pre and post vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susanne Gretzinger, MD principal investigator
University Hospital Dresden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous idiotype-protein pulsed dendritic cells in people with Multiple Myeloma and Plasmocytoma, run by University Hospital Carl Gustav Carus at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specific T-cell proliferation/cytokine secretion. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2009.