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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Myeloma

Thank you

Trial Information

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


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.


Inclusion Criteria:



1. Recipient: Patient with IgG1, IgG2, or IgG4 Multiple Myeloma who has received or
planning to receive an allogeneic progenitor cell transplant from a HLA compatible
related donor (either 6/6 or 5/6 related donor).

2. Recipient: Have evidence of persistent or relapsing disease as demonstrated by
persistent serum peak (by either standard protein electrophoresis, immune fixation or
free light chain assays) or marrow infiltration. Serum peak must be greater or equal
than 0.2 gm/dl and represent more than 70% of the specific immunoglobulin subtype.
Patients who have adequate amount of monoclonal idiotype protein previously
cryopreserved on prior departmental laboratory protocols are also eligible to be
registered for vaccine production using the cryopreserved samples.

3. Recipient: Able to sign written informed consent.

4. Recipient: Age up to 70 years.

5. Recipient: Zubrod PS >/=2.

6. Recipient: Have no serious organ dysfunction as defined by serum creatinine <2.5
mg/dL, serum bilirubin <3 x upper limit of normal, SGPT <4 x upper limit of normal.

7. Recipient: Negative donor infectious disease panel: Hepatitis B surface antigen
(HBsAg), Anti-Hepatitis B core antibody (HBcAb), Anti-Hepatitis C Virus antibody (HCV
Ab), Anti-Human Immunodeficiency Virus (HIV) antibody (HIV 1/2 type O Ab), Anti-Human
T cell lymphotrophic Virus (HTLV) antibody (HTLV I/II Ab), Rapid Plasma Reagen (RPR),
Cytomegalovirus antibody (CMV), HCV/HIV Nucleic Acid Test, West Nile Virus Nucleic
Acid Test, Sickledex, T Cruzi AB. Additional tests shall be performed as required to
assess the possibility of transmission of other infectious or non-infectious
diseases.

8. Recipient: Negative serum Beta HCG test in a women with child bearing potential (not
post-menopausal for 12 months or no previous surgical sterilization) and willing to
use an effective contraceptive measure while on study. Mothers should not breastfeed
during the study.

9. Donor: Able to sign written informed consent and be willing to provide donor
lymphocytes.

10. Donor: Age 18 - 75 years

11. Donor: No physical contraindications to lymphocyte collection (i.e. severe
atherosclerosis, auto-immune disease, cerebrovascular accident, prior malignancy less
than 5 years ago other than non-melanoma skin cancer treated with surgery). Donors
with severe atherosclerosis by history will receive a cardiology consult and be
judged eligible on a case by case basis.

12. Donor: Negative donor infectious disease panel: Hepatitis B surface antigen (HBsAg),
Anti-Hepatitis B core antibody (HBcAb), Anti-Hepatitis C Virus antibody (HCV Ab),
Anti-Human Immunodeficiency Virus (HIV) antibody (HIV 1/2 type O Ab), Anti-Human T
cell lymphotrophic Virus (HTLV) antibody (HTLV I/II Ab), Rapid Plasma Reagen (RPR),
Cytomegalovirus antibody (CMV), HCV/HIV Nucleic Acid test. Additional tests shall be
performed as required to assess the possibility of transmission of other infectious
or non-infectious diseases.

13. Donor: Negative serum Beta HCG test in a woman with child bearing potential (not
post-menopausal for 12 months or no previous surgical sterilization) must use an
effective method of contraception until at least 1 month after lymphocyte collection.
Mothers should not breastfeed during the study.

Exclusion Criteria:

1) Recipient with IGg3 Multiple Myeloma.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Complete Remission

Outcome Description:

Efficacy characterized by complete remission (CR).

Outcome Time Frame:

3 months after infusion

Safety Issue:

No

Principal Investigator

Muzaffar H. Qazilbash, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2004-0660

NCT ID:

NCT01174082

Start Date:

July 2010

Completion Date:

Related Keywords:

  • Myeloma
  • Multiple Myeloma
  • Vaccine
  • Lymphocyte Infusion
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030