Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/13/2018 |
| Start Date: | March 2010 |
| End Date: | December 2022 |
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.
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.
- 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.
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.
Inclusion Criteria:
- 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
- Negative pregnancy test and adequate contraception method(s)
- DLCO (adjusted) > 50%
- Cardiac Ejection Fraction > 45%
- Laboratory results as defined in protocol
Exclusion Criteria:
- 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
We found this trial at
3
sites
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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