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History of Changes for Study: NCT01067287
Blockage of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
Latest version (submitted September 5, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 10, 2010 None (earliest Version on record)
2 March 29, 2010 Recruitment Status, Study Status and Contacts/Locations
3 January 20, 2011 Study Status
4 July 14, 2011 Study Status
5 January 10, 2012 Sponsor/Collaborators and Study Status
6 May 22, 2012 Study Status and Contacts/Locations
7 June 14, 2012 Study Status and Contacts/Locations
8 November 14, 2012 Study Status and Study Identification
9 June 25, 2013 Study Status
10 November 22, 2013 Study Status
11 June 10, 2014 Study Status
12 August 5, 2014 Recruitment Status, Study Status and Contacts/Locations
13 September 15, 2014 Study Status
14 August 31, 2015 Study Status
15 January 21, 2016 Study Status
16 September 19, 2016 Study Status
17 June 30, 2017 Study Status
18 May 10, 2018 Study Status
19 May 16, 2019 Study Status
20 January 14, 2020 Study Status
21 December 21, 2020 Study Status
22 August 2, 2021 Study Status
23 September 5, 2022 Study Status
Comparison Format:

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Study NCT01067287
Submitted Date:  February 10, 2010 (v1)

Open or close this module Study Identification
Unique Protocol ID: 09-061
Brief Title: Blockage of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
Official Title: Blockage of PD-1 in Conjunction With the Dendritic Cell/Myeloma Vaccines Following Stem Cell Transplantation
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2010
Overall Status: Not yet recruiting
Study Start: February 2010
Primary Completion: May 2011 [Anticipated]
Study Completion: May 2011 [Anticipated]
First Submitted: July 29, 2009
First Submitted that
Met QC Criteria:
February 10, 2010
First Posted: February 11, 2010 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 10, 2010
Last Update Posted: February 11, 2010 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Beth Israel Deaconess Medical Center
Responsible Party:
Collaborators: Dana-Farber Cancer Institute
Brigham and Women's Hospital
Rambam Health Care Campus
Gateway for Cancer Research
United States Department of Defense
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief 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). 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.
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: dendritic cell fusion vaccine
CT-011
autologous stem cell transplant
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 35 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Group 1
Monoclonal antibody CT-011 will be given 1-3 months following autologous transplant. 3 doses will be given at 6 week intervals.
Drug: CT-011
Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses
Active Comparator: Group 2
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.
Drug: CT-011
Infusions starting one to three months following autologous transplant at 6 week intervals for a total of 3 doses
Biological: Dendritic Cell Fusion Vaccine
One week following each infusion of CT-011
Open or close this module Outcome Measures
Primary Outcome Measures:
1. First Stage: To explore immunological response to CT-011 in the post transplant period.
[ Time Frame: 3 years ]

2. Second Stage: To determine if cellular immunity is induced by treatment with monoclonal antibody CT-011 and DC/myeloma fusion cells in conjunction with stem cell transplant.
[ Time Frame: 3 years ]

Secondary Outcome Measures:
1. First Stage: To assess the toxicity associated with treating multiple myeloma patients with CT-011 in the post- autologous transplant setting.
[ Time Frame: 3 years ]

2. 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 ]

3. Second Stage: To correlate levels of circulating activated and regulatory T cells with immunologic response
[ Time Frame: 3 years ]

4. Second Stage: To define anti-tumor effects using serum markers, radiological studies, and time to progression.
[ Time Frame: 3 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: David Avigan, MD
Telephone: 617-667-9920
Study Officials: David Avigan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Locations: United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Contact:Principal Investigator: David Avigan, MD
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Contact:Principal Investigator: Nikhil Munshi, MD
Israel
Rambam Medical Center
Haifa, Israel
Contact:Contact: Irit Avivi, MD
Contact:Principal Investigator: Irit Avivi, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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