FM 140 vs FM100 Study in Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this clinical research study is to learn if there is a difference in transplant
      outcomes between two different doses of melphalan given in combination with fludarabine
      followed by transfusion of a related or unrelated volunteer donor's peripheral blood or bone
      marrow progenitor cells (allogeneic stem cell transplant) in patients with multiple myeloma.
      This study will also look at whether treatment with a antibody called rituximab against a
      specific type of lymphocyte (B cell) will reduce the risks of developing graft versus host
      disease after transplant. The safety of these treatments will also be compared.
    

Detailed description: 
      Fludarabine is a chemotherapy drug that is used in various diseases. Melphalan is a
      chemotherapy drug that has been widely used in the treatment of multiple myeloma for many
      years.

      Before beginning therapy, patients will have a complete work-up. This includes a bone marrow
      aspiration and biopsy, bone survey, blood tests, and tests to check the heart and lung
      function. All patients will receive tacrolimus and methotrexate to prevent graft-versus-host
      disease.

      Patients in this study will be randomly picked (as in the toss of a coin) to be in one of two
      treatment groups. There is an equal chance that a patient will be in either group.

      Patients in the first group will receive fludarabine through the vein every day for four
      days. On the fourth day, patients will receive a dose of melphalan through the vein over 20
      minutes. On the following day, patients will receive the donor cells as an infusion through
      their catheter.

      Patients in the second group will receive fludarabine through the vein every day for four
      days. Patients in this group will receive a lower dose of melphalan through the vein over 20
      minutes. After the last dose of fludarabine, patients will receive the donor cells as an
      infusion through their catheter the next day.

      If you have an unrelated or a mismatched donor, you will receive the drug ATG (Thymoglobulin)
      by vein over 6 hours on Days -3, -2, and -1 (the 3 days before the transplant), to prevent
      graft versus host disease (GVHD) and to help engraftment.

      Patients in both group will be receiving the monoclonal antibody called rituximab weekly
      starting on the fifth day before the stem cell transplant for a total of 4 doses.

      Patients will remain in the hospital for about 4-6 weeks and in Houston Medical Center area
      at least 100 days after transplantation.

      Patients whose disease gets worse will be taken off study. These patients will continue to be
      followed for survival.

      This is an investigational study. All of the drugs used in this study are commercially
      available. The FDA has approved melphalan for the treatment of myeloma. Fludarabine is not
      approved for the treatment of myeloma but has been used for years as a way to prepare
      patients for transplant. About 30 to 60 patients will take part in this study. About 45
      patients will be enrolled at M. D. Anderson.
    

Intervention name(s): Melphalan; Fludarabine; Stem Cell Infusion; Rituximab
Intervention type(s): Drug; Drug; Procedure; Drug
Intervention description(s): Arm 1 = 140 mg/m^2 intravenous over 20 Minutes on Day -1; Arm 2 = 100 mg/m^2 intravenous over 20 Minutes on Day -1.; 30 mg/m^2 intravenous daily over 30 Minutes for 4 Days (Beginning Day -4).; Stem Cell Infusion on Day 0.; 375 mg/m^2 intravenous on Day -5, +2 +9 and +16.
Other intervention name(s): Alkeran; Fludara; Fludarabine Phosphate; Allogeneic Peripheral Blood Stem Cell Transfusion; APBSCT; Bone Marrow Transplantation; BMT; Rituxan
Intervention MeSH terms: Rituximab; Fludarabine; Fludarabine phosphate; Melphalan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Myeloma; Fludarabine; Fludara; Fludarabine Phosphate; Melphalan; Alkeran; Stem Cell Infusion; Stem Cell Transfusion; SCT; Allogeneic Peripheral Blood Stem Cell Transfusion; APBSCT; Bone Marrow Transplantation; BMT; Rituxan; Rituximab; FM140; FM100