Study of Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus
Condition: Multiple Myeloma; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Myelogenous Leukemia; Lymphoblastic Leukemia
MeSH terms: Leukemia; Multiple Myeloma; Leukemia, Myeloid; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and
      sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy
      followed by donor cord blood transplantation.
    

Detailed description: 
      -  The chemotherapy portion of the study involves the intravenous administration of
           fludarabine, for six days (Days 8, 7, 6, 5,4, and 3) before transplant, melphalan, for
           one day (Day 2) before transplant. Antithymocyte globulin, or thymoglobulin, will be
           given IV daily for 4 days (days 7, 5, 3, and 1 before transplant). This drug also helps
           to suppress the immune system, allowing the cord blood cells to grow and reproduce.

        -  Immunosuppression therapy consists of the drugs tacrolimus and sirolimus. The patient
           will receive these 3 days before the transplant and every day for 3-6 months after
           transplant. After the first 100 days post transplant, the doses of tacrolimus and
           sirolimus will begin to be reduced with the goal of having the patient off both drugs by
           6-9 months after transplant.

        -  After completion of conditioning therapy described above, the patient will receive 2
           cord blood units 1-6 hours apart. To help with engraftment, the patient will also
           receive G-CSF starting on day five after transplant, until the patients white blood
           cells recover.

        -  Follow-up visits will continue every 6 months after the last treatment dose and will
           last up to 2 years.

        -  Blood tests will be drawn frequently to test whether the donor's immune cells have
           engrafted as well as to test the levels of Tacrolimus and Sirolimus.
    

Intervention name(s): Tacrolimus; Sirolimus; G-CSF; Antithymocyte globulin; Thymoglobulin; Fludarabine; Melphalan
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.; Given three days before transplant and every day for 3-6 months after transplant. After first 100 days post-transplant, the dose will be reduced.; Given starting on day 5 after transplant until the subjects white blood cell count recovers.; Given intravenously for 4 days before transplant (days 7, 5, 3, 1).; Given intravenously for 4 days before transplant (days 7, 5, 3, 1).; Given intravenously for six days prior to transplant (days 8,7,6,5,4,3).; Given intravenously on day 2 before transplant.
Intervention MeSH terms: Sirolimus; Fludarabine; Melphalan; Tacrolimus; Thymoglobulin; Antilymphocyte Serum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hematologic malignancy; Cord blood transfusion; Graft versus host disease; tacrolimus; sirolimus