Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant

Myeloma Clinical Trial

Official title: Phase II Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if vaccinating a donor with your purified myeloma protein and then injecting it back into you will help your immune system control the multiple myeloma.

Clinical Trial Description

A vaccine will be made of tumor protein taken from your plasma (liquid part of the blood) and KLH (a protein designed to increase the immune response of the vaccine). By vaccinating your brother or sister with protein made from the tumor, researchers hope to increase the antitumor effect of the stem cells. KLH is used to help the immune response.

Study Treatment Schedule:

If you are found to be eligible to take part in this study, you and your brother or sister will receive a vaccine with KLH. This research involves various steps. In Step 1, a large sample of your plasma will be collected through a vein using a blood separator device. This plasma will be sent to the MD Anderson GMP lab to prepare the vaccine. It takes about 3 months to create your myeloma-specific vaccine. It takes about 3 months to prepare enough vaccine for the next phases of the study.

In Step 2, your brother or sister will receive the vaccine with KLH as an injection under the skin 8 weeks, 6 weeks, and 2 weeks before collection of his/her lymphocytes (immune fighting cells). After each injection, your brother or sister will receive an injection of a medication called GM-CSF that helps the body's response to the vaccine. GM-CSF is given under the skin near the site of the vaccination every day for 4 days, starting the day of the vaccination.

In Step 3, your brother or sister will have apheresis. During apheresis, their blood is passed through a "cell separator" and the lymphocytes (immune fighting cells) are collected. A portion of these cells will be given to you on this day. You will get these cells through a vein while the remainder is stored and frozen for research and/or use later on if you fail to respond to the first infusion.

In Step 4, you will receive the vaccine with KLH. It will be given under the skin immediately after you get the infusion of donor cells, and again 4 and 8 weeks after the lymphocyte infusion. After each vaccine, you will receive an injection of a medication called sargramostim (GM-CSF) that helps the body's response to the vaccine. GM-CSF is given under the skin near the site of the vaccination every day for 4 days, starting the day of the vaccination.

If after 6 months you are not responding to the vaccine, you will be allowed to receive 3 additional vaccines, as long as you did not develop graft versus host disease or any other serious side effects to the first vaccine. The vaccines and follow-up schedule is exactly like the first.

Study Visits:

Within 10 days before you receive the infusion of your donor's cells and within 72 hours before each vaccine injection, the following tests and procedures will be performed:

• Your medical history will be recorded.

• You will have a physical exam, including measurement of your vital signs.

• You will be checked for possible reactions to your treatment, including graft-versus-host disease (GVHD). Infused donor cells may react against your body.

• You will be asked about any side effects you may have had since the first vaccine injection.

• Blood (about 6-12 teaspoons) will be drawn for routine tests and to check your kidney and liver function, as well as the status of your immune system. Part of the blood will be used to test for CMV, hepatitis B, hepatitis C, HIV, HTLV, syphilis, West Nile virus, sickle cell anemia, and Chagas disease. Part of the blood collection will also be used for a pregnancy test for females who are able to have children. To continue to receive infusions of your donor's cells, the pregnancy test must be negative.

• You will have x-rays or bone marrow aspirates and biopsies to assess the response of your disease.

These visits will require 1 day of your time.

Long-Term Follow-Up:

Once a month during Months 3, 6, 12, 18, and 24 months after your last vaccine, the following tests and procedures will be performed:

• Your medical history will be recorded.

• You will have a physical exam, including measurement of your vital signs.

• You will be checked for possible reactions to your treatment, including GVHD.

• Blood (about 6-12 teaspoons) will be drawn to check your kidney and liver, function as well as the status of your immune system. Part of the blood collection will also be used for a pregnancy test for females who are able to have children. To continue to receive infusions of your donor's cells, the pregnancy test must be negative.

• You will have a bone marrow biopsy and aspiration. It may be repeated more often, if your doctor thinks it is needed.

If you are not able to return to MD Anderson, your study doctor may agree to allow you to have these tests and procedures at your local doctor's office. Your local doctor will need to send the results to research staff at MD Anderson.

Once a year, starting 2 years after you receive the last infusion of your donor's cells, you will be contacted by phone to check on your health status.

Length of Study Participation:

You will be considered off study after 5 years. You will be taken off study at any time if lymphocytes cannot be collected, not enough lymphocytes can be collected, your doctor thinks it is needed, the recipient is not able to receive the vaccine, the study doctor thinks it is in your best interest, you need a treatment that is not allowed while on this study, you are unable to keep appointments, or you have intolerable side effects.

This is an investigational study. The myeloma-specific vaccine is not FDA approved or commercially available, and it has been authorized for use in research only. Up to 10 patients will take part in this study. All will be enrolled at MD Anderson. ;

Related Conditions & MeSH terms

• Multiple Myeloma
• Myeloma
• Neoplasms, Plasma Cell

• NCT number: NCT01174082
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: July 20, 2010
• Completion date: February 23, 2017