Multiple MyelomaPhase 2NCT01067287
Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
A Phase 2 study testing CT-011 and Dendritic Cell Fusion Vaccine in people with Multiple Myeloma, run by Beth Israel Deaconess Medical Center at 3 sites in 2 countries.
Trial summary
The purpose of this research study is to determine the safety of CT-011 alone, as well as the combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell transplantation (ASCT). 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?
- CT-011 and Dendritic Cell Fusion Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Mar 2010to Jun 2026
- Phase
- Phase 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 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 doses chemotherapy with stem cell rescue
- Patients must not have active of history of autoimmune disorders/conditions including Type I diabetes, Type II diabetes, vitiligo or stable hypothyroidism will not be considered exclusion criteria
- Patients with 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 a greater than nine week life expectancy
- >20% bone marrow involvement in plasmacytoma amenable to resection under local anesthesia
Show all 10Show fewer
- Negative pregnancy test and adequate contraception method(s)
- DLCO (adjusted) > 50%
- Cardiac Ejection Fraction > 45%
- Laboratory results as defined in 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
- History of allogeneic bone marrow/stem cell transplant
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
The purpose of this research study is to determine the safety of CT-011 alone, as well as the combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell transplantation (ASCT). We are also trying to find out what effect the combination has on the disease, including if it is more successful in preventing or delaying the disease from coming back, compared to treatment with autologous transplantation alone. ASCT is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer in the body. CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug given by infusion into a vein and are known to target specific cells (in this case, cells in the immune system). The dendritic cell fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body.
Read the detailed description
- There are two groups in this study: Group 1: All participants in this study group will receive infusions of CT-011 starting one to three months following autologous transplant. Participants in this group will receive a total of 3 doses of CT-011 at 6 week intervals. Group 2: All participants in this group will receive infusions of CT-011 starting one to three months following autologous transplant. Participants in this group will receive a total of 3 doses of CT-011 at 6 week intervals. In addition, they will receive a vaccination of the Dendritic Cell Fusion Vaccine one week following each infusion of CT-011.
- All participants (Group 1 and Group 2) will receive the following procedures: 1) Initial therapy for multiple myeloma: All participants will receive standard therapy to reduce the number of multiple myeloma cells in the body. 2) Prior to stem cell mobilization participants will undergo a physical exam, medical history, and blood tests to measure blood counts, liver and kidney function, multiple myeloma protein level, and research testing to measure the immune response against the multiple myeloma cells. A small amount of bone marrow will be removed from the participants hip. Participants will also undergo a skin test called "delayed-type hypersensitivity (DTH). 3) Prior to the autologous stem cell transplant, we will harvest stem cells from the participants blood and store then for the future transplant through a process called leukapheresis. 4) Within a few weeks of successful stem cell collection, participants will be admitted to the hospital for high dose chemotherapy with autologous stem cell transplantation (ASCT). 5) Approximately 1-3 months following ASCT, participants will undergo additional tests to assess their eligibility to proceed with treatment with CT-011 alone (group 1) or the combination of CT-011 and vaccination (group 2).
- If the post-transplant eligibility results meet the study requirements participants will receive 3 infusions of CT-011 at 6 week intervals. Prior to each infusion of CT-011, participants will undergo the following procedures: blood tests, urine sample, physical exam and EKG. Participants will be seen weekly to review any side effects, what medications they are taking, and will have a blood test an physical exam.
- For Group 2 participants only: Prior to autologous transplant, Group 2 participants will undergo several procedures to make the Dendritic Cell Fusion Vaccine. 1) Dendritic Cell Collection via leukapheresis 2) Tumor cell collection from the participants bone marrow. One week after receiving the CT-011 infusion, Group 2 participants will receive the study vaccine for a total of 3 vaccines.
- After the final treatment both Group 1 and Group 2 participants will receive a tumor DTH injection and DTH to Candida into the skin. At one, three and six months following the last study treatment participants will have blood tests, urine test, bone marrow aspirate/biopsy and a skeletal survey. At two, four and five months, participants will have a blood test.
- Conditions
- Multiple Myeloma
- Being tested
- CT-011, Dendritic Cell Fusion Vaccine
- Keywords
- dendritic cell fusion vaccine, CT-011, autologous stem cell transplant
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-011Drug
Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses
Dendritic Cell Fusion VaccineBiological
One week following each infusion of CT-011
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals. Receives: Drug: CT-011 |
| Group 2 | Active comparator | Vaccination with DC/myeloma fusion cells will be given 1-3 months following autologous transplant. Vaccination will be given at 6 weeks intervals. The monoclonal antibody CT-011 will be given 1 week following each vaccination. 3 doses of CT-011 will be given at 6 week intervals. Receives: Drug: CT-011; Biological: Dendritic Cell Fusion Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Stage: To explore immunological response to Pidilizumab (MDV9300) in the post-transplant period.
Immune response will be measured by assessing percentage of T cells that express IFNγ following ex-vivo exposure to tumor lysate, as determined by the ratio of the maximum IFNγ expression to the baseline level pre-transplantation. A threshold response of a 10 fold increase in T cells expressing IFNγ will be considered significant.
In the pilot phase, summary statistics (mean, median, range, standard error) will be used to report immunologic response on the entire patient cohort. In order to increase precision and provide more information about the immunologic response, the original sample size of 10 patients for the pilot study was increased up to 20. With 20 patients on this stage, the 90% C.I. will be no wider than 39.7%.
Measured: 3 years
Second Stage: To determine if cellular immunity is induced by treatment with monoclonal antibody Pidilizumab (MDV9300)and DC/myeloma fusion cells in conjunction with stem cell transplant.
Cellular immunity will be determined by measuring fold increase in IFNγ expression.
The combination of vaccination and Pidilizumab (MDV9300) will be considered promising if the study shows evidence of at least 75% patients with >10-fold increase in IFNγ expression, and would not be considered promising if >10-fold increase is observed in 50% or less patients. With total n=25 patients, the combination will be considered promising for further study if 17 or more patients demonstrate significant immune response.
Measured: 3 years
Secondary outcomes (4)
First Stage: Secondary objective: To assess the toxicity associated with treating multiple myeloma patients with Pidilizumab (MDV9300)in the post-autologous transplant setting.
Toxicity will be monitored and will be summarized for each grade.
Measured: 3 years
Second Stage: To assess the toxicity associated with treating multiple myeloma patients with the combination with DC/myeloma fusion vaccine following autologous transplant.
Toxicity will be monitored and will be summarized for each grade.
Measured: 3 years
To correlate levels of circulating activated and regulatory T cells with immunologic response
Levels of circulating activated and regulatory T cells and CD14+PD-L1+ cells will be measured at pre-transplantation, post-transplantation and several times after Pidilizumab (MDV9300) with or without vaccination. We will measure the level and the ratio of activated T cells/regulatory T cells and CD14+PD-L1+ monocytes at each time point. We will evaluate the profile of the ratio across time, several possible metrics (fold-change among successive time point) will be explored to evaluate the trend in the ratio across time.
The correlation between the ratio and immunologic response (fold increase in IFNγ expression) will be assessed and reported using Spearman rank correlation at each time for 10 and 25 patients from each stage and total 35 patients from the study, by treating all measurement as continuous variables. At post-transplant time points, we will also compare the ratio of activated T cells/regulatory T cells for patients with and without significance immunologic response.
Measured: 3 years
To define anti-tumor effects using serum markers, radiological studies, and time to disease progression.
The percent of patients achieving a complete response (CR) following completion of therapy, including those converting from PR to CR after immunotherapy, will be reported for the phase II trial with descriptive statistics. Time to disease progression will also be characterized for with Kaplan-Meier curves.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2025
- Study completionJun 2026
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
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, Rambam Health Care Campus, Gateway for Cancer Research, United States Department of Defense
- 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
- NCT01067287
- Sponsor's protocol ID
- 09-061
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2009
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01067287
- Acronym / sponsor ID
- 09-061
- Conditions
- Multiple Myeloma
- Keywords
- dendritic cell fusion vaccine, CT-011, autologous stem cell transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Rambam Health Care Campus, Gateway for Cancer Research, United States Department of Defense
- Study start
- Mar 2010
- Primary completion
- Sep 2025 (actual)
- Study completion
- Jun 2026 (actual)
- First posted
- 11 Feb 2010 (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 purpose of this research study is to determine the safety of CT-011 alone, as well as the combination of the Dendritic cell fusion vaccine and CT-011, after autologous stem cell transplantation (ASCT). We are also trying to find out what effect the combination has on the disease, including if it is more successful in preventing or delaying the disease from coming back, compared to treatment with autologous transplantation alone. ASCT is a standard therapy for multiple myeloma that is often successful in significantly decreasing the amount of cancer in the body. CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug given by infusion into a vein and are known to target specific cells (in this case, cells in the immune system). The dendritic cell fusion vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells. Unlike a standard vaccine that is used to prevent infections, cancer vaccines are being studied to see if they can fight cancers that are already in the body.
Detailed description
- There are two groups in this study: Group 1: All participants in this study group will receive infusions of CT-011 starting one to three months following autologous transplant. Participants in this group will receive a total of 3 doses of CT-011 at 6 week intervals. Group 2: All participants in this group will receive infusions of CT-011 starting one to three months following autologous transplant. Participants in this group will receive a total of 3 doses of CT-011 at 6 week intervals. In addition, they will receive a vaccination of the Dendritic Cell Fusion Vaccine one week following each infusion of CT-011.
- All participants (Group 1 and Group 2) will receive the following procedures: 1) Initial therapy for multiple myeloma: All participants will receive standard therapy to reduce the number of multiple myeloma cells in the body. 2) Prior to stem cell mobilization participants will undergo a physical exam, medical history, and blood tests to measure blood counts, liver and kidney function, multiple myeloma protein level, and research testing to measure the immune response against the multiple myeloma cells. A small amount of bone marrow will be removed from the participants hip. Participants will also undergo a skin test called "delayed-type hypersensitivity (DTH). 3) Prior to the autologous stem cell transplant, we will harvest stem cells from the participants blood and store then for the future transplant through a process called leukapheresis. 4) Within a few weeks of successful stem cell collection, participants will be admitted to the hospital for high dose chemotherapy with autologous stem cell transplantation (ASCT). 5) Approximately 1-3 months following ASCT, participants will undergo additional tests to assess their eligibility to proceed with treatment with CT-011 alone (group 1) or the combination of CT-011 and vaccination (group 2).
- If the post-transplant eligibility results meet the study requirements participants will receive 3 infusions of CT-011 at 6 week intervals. Prior to each infusion of CT-011, participants will undergo the following procedures: blood tests, urine sample, physical exam and EKG. Participants will be seen weekly to review any side effects, what medications they are taking, and will have a blood test an physical exam.
- For Group 2 participants only: Prior to autologous transplant, Group 2 participants will undergo several procedures to make the Dendritic Cell Fusion Vaccine. 1) Dendritic Cell Collection via leukapheresis 2) Tumor cell collection from the participants bone marrow. One week after receiving the CT-011 infusion, Group 2 participants will receive the study vaccine for a total of 3 vaccines.
- After the final treatment both Group 1 and Group 2 participants will receive a tumor DTH injection and DTH to Candida into the skin. At one, three and six months following the last study treatment participants will have blood tests, urine test, bone marrow aspirate/biopsy and a skeletal survey. At two, four and five months, participants will have a blood test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: CT-011Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals. |
| Group 2 | Active comparator | Drug: CT-011, Biological: Dendritic Cell Fusion VaccineVaccination with DC/myeloma fusion cells will be given 1-3 months following autologous transplant. Vaccination will be given at 6 weeks intervals. The monoclonal antibody CT-011 will be given 1 week following each vaccination. 3 doses of CT-011 will be given at 6 week intervals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with multiple myeloma who are potential candidates for high doses chemotherapy with stem cell rescue
- Patients must not have active of history of autoimmune disorders/conditions including Type I diabetes, Type II diabetes, vitiligo or stable hypothyroidism will not be considered exclusion criteria
- Patients with 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 a greater than nine week life expectancy
Key exclusion criteria (6 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 |
|---|---|---|
| CT-011Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses | Drug | Group 1, Group 2 |
| Dendritic Cell Fusion VaccineOne week following each infusion of CT-011 | Biological | Group 2 |
Primary outcome
First Stage: To explore immunological response to Pidilizumab (MDV9300) in the post-transplant period.
Time frame: 3 years
Immune response will be measured by assessing percentage of T cells that express IFNγ following ex-vivo exposure to tumor lysate, as determined by the ratio of the maximum IFNγ expression to the baseline level pre-transplantation. A threshold response of a 10 fold increase in T cells expressing IFNγ will be considered significant. In the pilot phase, summary statistics (mean, median, range, standard error) will be used to report immunologic response on the entire patient cohort. In order to increase precision and provide more information about the immunologic response, the original sample size of 10 patients for the pilot study was increased up to 20. With 20 patients on this stage, the 90% C.I. will be no wider than 39.7%.
Second Stage: To determine if cellular immunity is induced by treatment with monoclonal antibody Pidilizumab (MDV9300)and DC/myeloma fusion cells in conjunction with stem cell transplant.
Time frame: 3 years
Cellular immunity will be determined by measuring fold increase in IFNγ expression. The combination of vaccination and Pidilizumab (MDV9300) will be considered promising if the study shows evidence of at least 75% patients with >10-fold increase in IFNγ expression, and would not be considered promising if >10-fold increase is observed in 50% or less patients. With total n=25 patients, the combination will be considered promising for further study if 17 or more patients demonstrate significant immune response.
4 secondary outcomes
First Stage: Secondary objective: To assess the toxicity associated with treating multiple myeloma patients with Pidilizumab (MDV9300)in the post-autologous transplant setting.
Time frame: 3 years
Second Stage: To assess the toxicity associated with treating multiple myeloma patients with the combination with DC/myeloma fusion vaccine following autologous transplant.
Time frame: 3 years
To correlate levels of circulating activated and regulatory T cells with immunologic response
Time frame: 3 years
To define anti-tumor effects using serum markers, radiological studies, and time to disease progression.
Time frame: 3 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 6 Nov 2026.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-011 and Dendritic Cell Fusion Vaccine in people with Multiple Myeloma, run by Beth Israel Deaconess Medical Center at 3 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 10 inclusion and 6 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 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 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?
First Stage: To explore immunological response to Pidilizumab (MDV9300) in the post-transplant period. (time frame: 3 years). The study lists 2 primary outcomes in all. 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 6 Nov 2026.