Vaccination With Dendritic Cell/Tumor Fusions With Autologous Stem Cell Transplants in Patients With Multiple Myeloma

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00458653

Collaborator

Massachusetts General Hospital (Other), Dana-Farber Cancer Institute (Other), Brigham and Women's Hospital (Other), Rambam Health Care Campus (Other)

Enrollment

Locations

Arms

183

Duration (Months)

11.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Biological: Dendritic Cell Tumor Fusion	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

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. [5 years]

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 [5 years]
To determine if vaccination with DC/tumor cell fusions results in clinical disease response in patients with evidence of residual disease post-transplant [5 years]
To determine the time to disease progression in this participant population. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02114
2	Dana-Farber Cancer Institute/Brigham & Women's Hospital	Boston	Massachusetts	United States	02115
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02215
4	Rambam Medical Center	Haifa		Israel	31096