Multiple MyelomaPhase 1NCT00459069
The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
A Phase 1 study testing Dendritic Cell Tumor Fusion Vaccine in people with Multiple Myeloma, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Dendritic Cell Tumor Fusion Vaccine
- Type of treatment
- Vaccines
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to Nov 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
- Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
- 18 years of age or older
- ECOG Performance Status of 0-1 with a greater than nine week life expectancy
- > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
- Laboratory results within ranges outlined in protocol
- Negative pregnancy test and adequate contraception method(s) must be documented
Who cannot join
- History of clinically significant venous thromboembolism
- Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
- Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
- Clinically significant autoimmune disease
- HIV positive
- Serious intercurrent illness
- Taking systemic corticosteroids within 4 weeks of treatment with study drug
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02114
About this study
The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.
Read the detailed description
- To create the study vaccine, cells will be removed from the participants tumor and fused (mixed) with powerful immune system stimulating cells (dendritic cells) obtained from the participants blood.
- Not everyone who participates in this study will be receiving the same amount of study vaccine. A small group of people will be enrolled into the study and given a certain dose. If they tolerate it well, the next group of people enrolled will receive a higher dose. This will continue until the highest dose level tolerated is determined.
- Once the screening tests are completed and it is determined the participant is eligible, they will undergo some baseline procedures. In an effort to make the study vaccine, tumor cells and dendritic cells will be collected from the participant. Tumor cells may be collected from bone marrow or from a collection of tumor cells called a plasmacytoma. A decision will be made based upon the location of the cancer.
- A bone marrow aspiration/biopsy will be performed during the following time points: at screening, prior to the first vaccination, and at 1 month, 3 months, and 6 months after the final study vaccination. These will be used to assess and follow the participants multiple myeloma.
- Leukapheresis will be performed to obtain dendritic cells. This procedure takes 2 to 4 hours to and involves the collection of a large number of white blood cells. Dendritic cells will be generated in the laboratory from white blood cells. If not enough white blood cells are collected, the participant may be asked to return to the clinic for an additional leukapheresis procedure.
- Before each vaccine is administered (weeks 0, 3, 6) the following study tests and procedures will be performed: skin test; blood test, physical exam and 24-hour urine collection. A physical exam and blood tests will be performed on the weeks when the participant does not receive the vaccine (weeks 1,2,4,5,7,8).
- The study schedule will consist of a fixed dose of the fused (mixed) cell vaccine under the skin every 3 weeks. Each study vaccine will be accompanied by an injection of GM-CSF. Participants will receive 2 or more vaccines depending upon the total number of fusion cells made, the dose the participant is assigned to receive and their response to the study vaccine.
- Follow-up after the vaccine treatment is completed will consist of the following: blood collection (1, 3 and 6 months after final study vaccination); bone marrow aspiration/biopsy (1, 3 and 6 months after final study vaccination); physical exam (1, 2, 3, 4, 5 and 6 months after final study vaccination); radiologic tumor assessment (1, 3 and 6 months after final study vaccination.
- Conditions
- Multiple Myeloma
- Being tested
- Dendritic Cell Tumor Fusion Vaccine
- Keywords
- tumor vaccine, GM-CSF
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dendritic Cell Tumor Fusion VaccineBiological
Vaccine administered on weeks 0, 3 and 6
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the toxicity associated with vaccination of patients multiple myeloma with dendritic cell(DC)/tumor cell fusions co-administered with GM-CSF.
Measured: 5 years
Secondary outcomes (2)
To determine whether evidence of tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusion cells co-administered with GMCSF
Measured: 5 years
to determine if vaccination with DC/tumor cell fusions co-administered with GM-CSF results in clinical disease response.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startJul 2004
- Primary completionJun 2008
- Study completionNov 2009
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.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Investigators
- David Avigan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459069
- Sponsor's protocol ID
- 03-240
- Status last verified
- Jan 2010
- First submitted
- 10 Apr 2007
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Dendritic Cell/Tumor Fusions as a Novel Tumor Vaccine in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00459069
- Acronym / sponsor ID
- 03-240
- Conditions
- Multiple Myeloma
- Keywords
- tumor vaccine, GM-CSF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital
- Study start
- Jul 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 11 Apr 2007 (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.
The main purpose of this study is to test the safety of dendritic cell tumor fusion study vaccine and to determine the type and severity of any side effects associated with this study vaccine. Cancer cells have unique markers that distinguish them from normal cells of the body. These markers can potentially serve as targets for the immune system. Dendritic cells are normally found in small amounts in the body and are responsible for immune responses against "foreign" substances that enter the body. Animal studies have shown that these fused cells can stimulate powerful anti-tumor responses.
Detailed description
- To create the study vaccine, cells will be removed from the participants tumor and fused (mixed) with powerful immune system stimulating cells (dendritic cells) obtained from the participants blood.
- Not everyone who participates in this study will be receiving the same amount of study vaccine. A small group of people will be enrolled into the study and given a certain dose. If they tolerate it well, the next group of people enrolled will receive a higher dose. This will continue until the highest dose level tolerated is determined.
- Once the screening tests are completed and it is determined the participant is eligible, they will undergo some baseline procedures. In an effort to make the study vaccine, tumor cells and dendritic cells will be collected from the participant. Tumor cells may be collected from bone marrow or from a collection of tumor cells called a plasmacytoma. A decision will be made based upon the location of the cancer.
- A bone marrow aspiration/biopsy will be performed during the following time points: at screening, prior to the first vaccination, and at 1 month, 3 months, and 6 months after the final study vaccination. These will be used to assess and follow the participants multiple myeloma.
- Leukapheresis will be performed to obtain dendritic cells. This procedure takes 2 to 4 hours to and involves the collection of a large number of white blood cells. Dendritic cells will be generated in the laboratory from white blood cells. If not enough white blood cells are collected, the participant may be asked to return to the clinic for an additional leukapheresis procedure.
- Before each vaccine is administered (weeks 0, 3, 6) the following study tests and procedures will be performed: skin test; blood test, physical exam and 24-hour urine collection. A physical exam and blood tests will be performed on the weeks when the participant does not receive the vaccine (weeks 1,2,4,5,7,8).
- The study schedule will consist of a fixed dose of the fused (mixed) cell vaccine under the skin every 3 weeks. Each study vaccine will be accompanied by an injection of GM-CSF. Participants will receive 2 or more vaccines depending upon the total number of fusion cells made, the dose the participant is assigned to receive and their response to the study vaccine.
- Follow-up after the vaccine treatment is completed will consist of the following: blood collection (1, 3 and 6 months after final study vaccination); bone marrow aspiration/biopsy (1, 3 and 6 months after final study vaccination); physical exam (1, 2, 3, 4, 5 and 6 months after final study vaccination); radiologic tumor assessment (1, 3 and 6 months after final study vaccination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed diagnosis of multiple myeloma: Stage I not requiring initiation of chemotherapy; Stage I, II or III patients felt to be clinically stable and having received at least one prior chemotherapy regimen
- Measurable disease as defined by a history of an elevated M component in plasma or urine or free kappa.lambda light chains in serum
- 18 years of age or older
- ECOG Performance Status of 0-1 with a greater than nine week life expectancy
- > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
Key exclusion criteria (7 listed)
- History of clinically significant venous thromboembolism
- Received other immunotherapy treatment in the past 4 weeks prior to the initiation of cell collections for vaccine generation
- Chemotherapy or radiation therapy 4 weeks prior to the first vaccine
- Clinically significant autoimmune disease
- HIV positive
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 |
|---|---|---|
| Dendritic Cell Tumor Fusion VaccineVaccine administered on weeks 0, 3 and 6 | Biological | – |
Primary outcome
To assess the toxicity associated with vaccination of patients multiple myeloma with dendritic cell(DC)/tumor cell fusions co-administered with GM-CSF.
Time frame: 5 years
2 secondary outcomes
To determine whether evidence of tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusion cells co-administered with GMCSF
Time frame: 5 years
to determine if vaccination with DC/tumor cell fusions co-administered with GM-CSF results in clinical disease response.
Time frame: 5 years
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 12 Jan 2010.
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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.
David Avigan, MD principal investigator
Beth Israel Deaconess Medical Center
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 Dendritic Cell Tumor Fusion Vaccine in people with Multiple Myeloma, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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 7 inclusion and 7 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 12 Jan 2010. 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 United States. 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?
To assess the toxicity associated with vaccination of patients multiple myeloma with dendritic cell(DC)/tumor cell fusions co-administered with GM-CSF. (time frame: 5 years). 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 12 Jan 2010.