Status:
TERMINATED
Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Myeloma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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 mye...
Detailed 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 si...
Eligibility Criteria
Inclusion
- 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).
- 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.
- Recipient: Able to sign written informed consent.
- Recipient: Age up to 70 years.
- Recipient: Zubrod PS \>/=2.
- 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.
- 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.
- 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.
- Donor: Able to sign written informed consent and be willing to provide donor lymphocytes.
- Donor: Age 18 - 75 years
- 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.
- 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.
- 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
- 1\) Recipient with IGg3 Multiple Myeloma.
Key Trial Info
Start Date :
July 20 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 23 2017
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01174082
Start Date
July 20 2010
End Date
February 23 2017
Last Update
June 1 2018
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030