Relapsed Multiple MyelomaPhase 1/2NCT01272466
Vaccination With Peptides From Anti-apoptotic Proteins in Relapsed Multiple Myeloma
A Phase 1/2 study testing peptides derived from antiapoptotic proteins in people with Relapsed Multiple Myeloma, run by Herlev Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Relapsed Multiple Myeloma
- What is being tested?
- peptides derived from antiapoptotic proteins
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2010to 1 Jan 2015
- Phase
- Phase 1/2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Haematology, Odense University Hospital
Odense, 5000
About this study
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
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.
- Conditions
- Relapsed Multiple Myeloma
- Being tested
- peptides derived from antiapoptotic proteins
- Keywords
- multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peptides derived from antiapoptotic proteinsBiological
8 Vaccinations on day 2 and 9 in every bortezomib treatment series
| Study group | Role | What they receive |
|---|---|---|
| peptides from antiapoptotic proteins | Experimental | Not described Receives: Biological: peptides derived from antiapoptotic proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2012
- Study completion1 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Principal investigator, Lene Meldgaard Knudsen, Herlev Hospital
- Investigators
- Lene M Knudsen, M.D, Principal investigator, Department of Haematology, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272466
- Sponsor's protocol ID
- 2006-003619-29
- Status last verified
- Aug 2018
- First submitted
- 3 Jan 2011
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01272466
- Acronym / sponsor ID
- 2006-003619-29
- Conditions
- Relapsed Multiple Myeloma
- Keywords
- multiple myeloma, vaccination, antiapoptotic proteins, proteasome inhibition
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- Feb 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- 1 Jan 2015 (actual)
- First posted
- 7 Jan 2011 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| peptides from antiapoptotic proteins | Experimental | Biological: peptides derived from antiapoptotic proteins |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| peptides derived from antiapoptotic proteins8 Vaccinations on day 2 and 9 in every bortezomib treatment series | Biological | peptides from antiapoptotic proteins |
Primary outcome
Number of participants with adverse events
Time frame: 15 months
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 31 Aug 2018.
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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.
Lene M Knudsen, M.D principal investigator
Department of Haematology, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing peptides derived from antiapoptotic proteins in people with Relapsed Multiple Myeloma, run by Herlev Hospital at 1 site in Denmark.
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 5 inclusion and 8 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 31 Aug 2018. 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 Denmark. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of participants with adverse events (time frame: 15 months). 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 31 Aug 2018.