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Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

Blockade of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

First Stage: To explore immunological response to CT-011 in the post transplant period.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

David Avigan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

09-061

NCT ID:

NCT01067287

Start Date:

March 2010

Completion Date:

Related Keywords:

  • Multiple Myeloma
  • dendritic cell fusion vaccine
  • CT-011
  • autologous stem cell transplant
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115