Trial of ID-Specific Donor Vaccinated Lymphocyte Infusion for Patients With Myeloma Relapsing or Failing to Achieve a Complete Remission After an Allogenic Transplant
Condition: Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: KLH Vaccine; KLH-id Vaccine; GM-CSF; Apheresis; Donor Lymphocyte Infusion (DLI)
Intervention description: Donor: 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to lymphocyte collection.
Patient: 0.5 cc subcutaneously, 3 times immediately after infusion of donor cells (DLI), and again 4 and 8 weeks post DLI.; Donor: 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to donor lymphocyte collection.
Patient: 0.5 cc subcutaneously, 3 times immediately after infusion of donor cells (DLI), and again 4 and 8 weeks post DLI.; 250 mcg/m2 subcutaneously daily for 4 days after each vaccine; Day 0 (day of lymphocyte collection) donors undergo a steady state pheresis to obtain lymphocytes.; Day 0, infusion to patient of collected donor cells.
Intervention MeSH terms: Vaccines; Sargramostim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Multiple Myeloma; Vaccine; Lymphocyte Infusion

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.
    

Eligibility criteria:

        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.