Cellular Therapy With Cord Blood Cells
Condition: Multiple Myeloma; Leukemia; Lymphoma
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma
Intervention: Fludarabine; Melphalan; Umbilical Cord Blood; Rituximab; Peripheral Blood Stem Cell Infusion
Intervention description: 30 mg/m^2 by vein for 4 Days (Day -10 through Day -7).; 140 mg/m^2 by vein for 1 Day (Day -7).; 1 UCB Unit by vein on Day -5.; 375 mg/m^2 by vein once weekly (Days -7, -1, +7, +14) for 4 Weeks (if appropriate).; Infusion of blood stem cells on Day 0.
Intervention MeSH terms: Rituximab; Fludarabine; Fludarabine phosphate; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Acute Myeloid Leukemia; Myelodysplastic Syndrome; Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Cellular Therapy; Umbilical Cord Blood Cells; Cord Blood Transplantation; Stem Cells; Stem Cell Transplantation; Allogeneic; Hematopoietic Stem Cell Transplantation; Graft vs. Host Disease; GVD; Fludarabine; Fludarabine Phosphate; Fludara; Melphalan; Rituximab; Rituxan; Leukemia; Lymphoma

Summary:

      The goal of this clinical research study is to learn if giving umbilical cord blood along
      with standard stem cells after high-dose chemotherapy will improve the response to a stem
      cell transplant. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with multiple myeloma (MM), acute myeloid leukemia (AML), myelodysplastic
             syndrome (MDS), acute lymphoblastic leukemia (ALL), non-Hodgkin's lymphoma (NHL),
             Hodgkin's lymphoma (HL), or chronic lymphocytic leukemia (CLL) in greater than first
             complete remission who are candidates for a non-ablative or reduced intensity
             conditioning regimen.

          2. Age up to 80 years.

          3. A related or unrelated donor who is HLA-matched at HLA, A, B, C, DR and DQ loci is
             acceptable (i.e. 10/10 matched related or unrelated donor, matched with molecular
             high-resolution technique per current standard for the BMT program). Donor must be
             willing to donate peripheral blood or bone marrow progenitor cells.

          4. Available cord blood unit must contain a minimum of 1.5 * 10^7 total nucleated cells
             per kg, and be at least a 4/6 HLA match with patient.

          5. Zubrod PS less than or equal to 2 or Lansky PS greater than or equal to 50%.

          6. Left ventricular ejection fraction >40%. No uncontrolled arrhythmias or symptomatic
             heart disease.

          7. Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC) and Diffusion
             Capacity (DLCO) >40%.

          8. Serum creatinine <2.0 mg/dL. Serum bilirubin <3 * upper limit of normal, SGPT <4 *
             upper limit of normal.

        Exclusion Criteria:

          1. Patients with active CNS disease

          2. Positive Beta HCG in a woman with child bearing potential defined as not
             post-menopausal for 12 months or no previous surgical sterilization.

          3. Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study, including but not limited to active uncontrolled infection,
             uncontrolled cardiac arrhythmia or ischemic event, or uncontrolled psychosis, major
             depression, or mania.

          4. Evidence of chronic, active hepatitis or cirrhosis, or HIV