Multiple MyelomaPhase 1NCT00458653
Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma
A Phase 1 study testing Dendritic Cell Tumor Fusion in people with Multiple Myeloma, run by Beth Israel Deaconess Medical Center at 4 sites in 2 countries.
Trial summary
The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. 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
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Apr 2005to Jul 2020
- 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
- Patients with multiple myeloma who are potential candidates for high dose chemotherapy
- Measurable disease as defined by a history of an elevated M component in plasma, urine, or free kappa/lambda light chains in the serum
- 18 years of age or older
- ECOG Performance Status of 0-1 with greater than a nine week life expectancy
- Patients with > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
- Negative pregnancy test, and adequate contraception method
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- DLCO (adjusted)> 50%
- Cardiac Ejection Fraction > 45%
- Laboratory values within the ranges outlined in the protocol
Who cannot join
- History of clinically significant venous thromboembolism
- Clinically significant autoimmune disease
- HIV positive
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- Pregnant or lactating women
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute/Brigham & Women's Hospital
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02215
About this study
Official title: Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma
The main purpose of this study is to test the safety and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor.
Read the detailed description
- The first group of participants on this study will receive up to 3 monthly doses of the study vaccine beginning about 1 month following the autologous transplant. If this is found to be safe, the next group will receive one additional study vaccine prior to the transplant and then up to 3 doses after the transplant.
- If the screening tests determine that the participant is eligible for the study, they will undergo dendritic cell collection by a procedure called leukapheresis. Leukapheresis involves the collection of white blood cells from the blood. Dendritic cells are grown from these white blood cells in the laboratory. Tumor cells will also be collected from the bone marrow through a bone marrow aspirate/biopsy.
- After cells have been collected for study vaccine generation, the participant may receive standard therapy to reduce the number of multiple myeloma cells in the body. The specific regimen will be determined by the participants multiple myeloma physician.
- The first group of patients will receive the study vaccine only after the transplant. If this is found safe then the second group will receive a single study vaccine prior to the transplant.
- Prior to the autologous stem cell transplant, we will harvest stem cells from the participants blood that will be used for the transplant later. G-CSF will be given as a daily injection beginning the day after the chemotherapy and GM-CSF injections will be started seven days after the chemotherapy. These injections will continue until after the stem cells are collected. Approximately 10 days after the chemotherapy, participants will undergo a leukapheresis procedure to collect the stem cells.
- Within a few weeks of successful stem cell collection, the participant will be admitted to the hospital for high dose chemotherapy with autologous stem cell transplantation.
- Conditions
- Multiple Myeloma
- Being tested
- Dendritic Cell Tumor Fusion
- Keywords
- DC/tumor cell fusions, GM-CSF, high dose chemotherapy
- 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 FusionBiological
Post-Transplant (Groups A and B): Given under the skin every four weeks for three doses.
Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Post-transplant vaccination Receives: Biological: Dendritic Cell Tumor Fusion |
| Group B | Experimental | Pre- and post-transplant vaccination Receives: Biological: Dendritic Cell Tumor Fusion |
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 multiple myeloma patients with dendritic cell/myeloma fusions and GM-CSF prior to stem cell mobilization and following high dose chemotherapy with stem cell rescue.
Measured: 5 years
Secondary outcomes (3)
To determine whether tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusions in conjunction with high dose chemotherapy with stem cell rescue
Measured: 5 years
To determine if vaccination with DC/tumor cell fusions results in clinical disease response in patients with evidence of residual disease post-transplant
Measured: 5 years
To determine the time to disease progression in this participant population.
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 startApr 2005
- Primary completionApr 2012
- Study completionJul 2020
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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Rambam Health Care Campus
- Responsible party
- Principal investigator, David Avigan, Beth Israel Deaconess Medical Center
- Investigators
- David Avigan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458653
- Sponsor's protocol ID
- 04-098
- Status last verified
- Jun 2023
- First submitted
- 10 Apr 2007
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT00458653
- Acronym / sponsor ID
- 04-098
- Conditions
- Multiple Myeloma
- Keywords
- DC/tumor cell fusions, GM-CSF, high dose chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Rambam Health Care Campus
- Study start
- Apr 2005
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jul 2020 (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 and determine the type and severity of any side effects of the Dendritic Cell Fusion Vaccine given in combination with an autologous transplant for patients with multiple myeloma. Autologous stem cell transplantation is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer. However, it is not a cure because at some point the multiple myeloma generally begins to grow again. Cancer vaccines are investigational agents that try to stimulate the immune system to recognize and fight against cancer cells. One type of cancer vaccine uses an immune stimulating cell of the body known as a dendritic cell. Research has shown that these dendritic cells can stimulate an immune response against the tumor.
Detailed description
- The first group of participants on this study will receive up to 3 monthly doses of the study vaccine beginning about 1 month following the autologous transplant. If this is found to be safe, the next group will receive one additional study vaccine prior to the transplant and then up to 3 doses after the transplant.
- If the screening tests determine that the participant is eligible for the study, they will undergo dendritic cell collection by a procedure called leukapheresis. Leukapheresis involves the collection of white blood cells from the blood. Dendritic cells are grown from these white blood cells in the laboratory. Tumor cells will also be collected from the bone marrow through a bone marrow aspirate/biopsy.
- After cells have been collected for study vaccine generation, the participant may receive standard therapy to reduce the number of multiple myeloma cells in the body. The specific regimen will be determined by the participants multiple myeloma physician.
- The first group of patients will receive the study vaccine only after the transplant. If this is found safe then the second group will receive a single study vaccine prior to the transplant.
- Prior to the autologous stem cell transplant, we will harvest stem cells from the participants blood that will be used for the transplant later. G-CSF will be given as a daily injection beginning the day after the chemotherapy and GM-CSF injections will be started seven days after the chemotherapy. These injections will continue until after the stem cells are collected. Approximately 10 days after the chemotherapy, participants will undergo a leukapheresis procedure to collect the stem cells.
- Within a few weeks of successful stem cell collection, the participant will be admitted to the hospital for high dose chemotherapy with autologous stem cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: Dendritic Cell Tumor FusionPost-transplant vaccination |
| Group B | Experimental | Biological: Dendritic Cell Tumor FusionPre- and post-transplant vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with multiple myeloma who are potential candidates for high dose chemotherapy
- Measurable disease as defined by a history of an elevated M component in plasma, urine, or free kappa/lambda light chains in the serum
- 18 years of age or older
- ECOG Performance Status of 0-1 with greater than a nine week life expectancy
- Patients with > 20% bone marrow involvement or plasmacytoma amenable to resection under local anesthesia
Key exclusion criteria (5 listed)
- History of clinically significant venous thromboembolism
- Clinically significant autoimmune disease
- HIV positive
- Serious intercurrent illness such as infection requiring IV antibiotics, or significant cardiac disease characterized by significant arrhythmia, ischemic coronary disease or congestive heart failure
- Pregnant or lactating women
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 FusionPost-Transplant (Groups A and B): Given under the skin every four weeks for three doses. Pre-Transplant (Group B): Injected under the skin in upper part of leg or arm prior to stem cell collection for ASCT | Biological | Group A, Group B |
Primary outcome
To assess the toxicity associated with vaccination of multiple myeloma patients with dendritic cell/myeloma fusions and GM-CSF prior to stem cell mobilization and following high dose chemotherapy with stem cell rescue.
Time frame: 5 years
3 secondary outcomes
To determine whether tumor specific cellular and humoral immunity can be induced by serial vaccination with DC/tumor cell fusions in conjunction with high dose chemotherapy with stem cell rescue
Time frame: 5 years
To determine if vaccination with DC/tumor cell fusions results in clinical disease response in patients with evidence of residual disease post-transplant
Time frame: 5 years
To determine the time to disease progression in this participant population.
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 22 Jun 2023.
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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
4 sites in 2 countries: 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 in people with Multiple Myeloma, run by Beth Israel Deaconess Medical Center at 4 sites in 2 countries.
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 9 inclusion and 5 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Israel. 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 multiple myeloma patients with dendritic cell/myeloma fusions and GM-CSF prior to stem cell mobilization and following high dose chemotherapy with stem cell rescue. (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 22 Jun 2023.