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

June 16, 2023 updated by: David Avigan, Beth Israel Deaconess Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02114
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute/Brigham & Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: 5 years
5 years
To determine the time to disease progression in this participant population.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beth Israel Deaconess Medical Center

Collaborators

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

Investigators

  • Principal Investigator: David Avigan, MD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

April 10, 2007

First Submitted That Met QC Criteria

April 10, 2007

First Posted (Estimated)

April 11, 2007

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-098

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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