Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Collaborators:	Massachusetts General Hospital Dana-Farber Cancer Institute Brigham and Women's Hospital Rambam Health Care Campus
Information provided by (Responsible Party):	David Avigan, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00458653

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Biological: Dendritic Cell Tumor Fusion	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Vaccination With Dendritic Cell/Tumor Fusions in Conjunction With Autologous Stem Cell Transplant in Patients With Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
To determine the time to disease progression in this participant population. [ Time Frame: TBD ] [ Designated as safety issue: No ]

Estimated Enrollment:	42
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group A Post-transplant vaccination	Biological: Dendritic Cell Tumor Fusion 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
Experimental: Group B Pre- and post-transplant vaccination	Biological: Dendritic Cell Tumor Fusion 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
DLCO (adjusted)> 50%
Cardiac Ejection Fraction > 45%
Laboratory values within the ranges outlined in the 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458653

Contacts

Contact: David Avigan, MD	617-667-9920	davigan@bidmc.harvard.edu
Contact: Emily Yuan	617-667-1998	yyuan1@bidmc.harvard.edu

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center	Recruiting
Boston, Massachusetts, United States, 02114
Contact: David Avigan, MD 617-667-9920
Sub-Investigator: Jacalyn Rosenblatt, MD
Sub-Investigator: James D Levine, MD
Sub-Investigator: Robin Joyce, MD
Sub-Investigator: Lynne Uhl, MD
Sub-Investigator: David McDermott, MD
Sub-Investigator: Jeffrey Zwicker, MD
Sub-Investigator: Dimitrios Tzachanis, MD
Sub-Investigator: Vassiliki Boussiotis, MD
Sub-Investigator: Richard Haspel, MD
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02215
Contact: Bimalangshu Dey, MD 617-724-1124 bdey@partners.org
Contact: Joanne Kennedy, RN (617) 726-6034 jkennedy9@partners.org
Sub-Investigator: Thomas Spitzer, MD
Sub-Investigator: Karen Ballen, MD
Sub-Investigator: Eyal Attar, MD
Sub-Investigator: Steve McAfee, MD
Sub-Investigator: Yi-Ben Chen, MD
Dana-Farber Cancer Institute/Brigham & Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Nikhil Munshi, MD 617-632-4166 nikhil_munshi@dfci.harvard.edu
Contact: Carolyn Revta 617-632-2365 carolyn_revta@dfci.harvard.edu
Sub-Investigator: Donald Kufe, MD
Sub-Investigator: Baldev Vasir, PhD
Sub-Investigator: Zekui Wu, MD
Sub-Investigator: Kenneth Anderson, MD
Sub-Investigator: Paul G Richardson, MD
Sub-Investigator: Robert Schlossman, MD
Sub-Investigator: Irene Ghobrial, MD
Sub-Investigator: Jacob Laubach, MD
Israel
Rambam Medical Center	Recruiting
Haifa, Israel, 31096
Contact: Irit Avivi, MD 97248543426 i_avivi@rambam.health.gov.il
Contact: Michal Tsumer 97248543426 m_tsumer@rambam.health.gov.il
Principal Investigator: Irit Avivi, MD
Sub-Investigator: Tamar Katz, MD
Sub-Investigator: Jacob M Rowe, MD
Sub-Investigator: Noam Benyamini, MD

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Rambam Health Care Campus

Investigators

Principal Investigator:

David Avigan, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	David Avigan, MD, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00458653 History of Changes
Other Study ID Numbers:	04-098
Study First Received:	April 10, 2007
Last Updated:	October 13, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

DC/tumor cell fusions
GM-CSF
high dose chemotherapy

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012