Autologous Transplant for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a study of a regimen of melphalan and autologous stem cells for patients with
      multiple myeloma. We hypothesize that this particular regimen will improve the survival of
      these patients.
    

Detailed description: 
      Before starting treatment in this study, the bone marrow transplant (BMT) doctor will check
      the subject's general health. Subjects will have the following tests and evaluations to find
      out if they can participate:--Medical history and physical examination, including height and
      weight.--Blood tests (approximately 4 - 5 tablespoons) --Urine tests--Chest
      x-ray--Electrocardiogram (ECG or EKG)--Heart Scan (MUGA)--Pulmonary Function Test (PFT)--Bone
      marrow biopsies and aspirates. --If Female subjects of child-bearing age will have a serum
      pregnancy test performed. After eligible patients have been completely staged and exercised
      consent, they may undergo one cycle of chemotherapy (cyclophosphamide and Mesna) and growth
      factor (G-CSF) to effect cytoreduction and mobilization of PBSC for collection. All patients
      will receive high-dose melphalan followed by an autologous stem cell transplant (SCT). Blood
      tests will be performed frequently to evaluate the subject's response to treatment and
      possible side effects of treatment. If necessary, platelet and red cell transfusions will be
      given to maintain adequate levels and antibiotics will be given to treat or prevent
      infection. Subjects may also require intravenous nutritional support and pain medications
      during or after transplantation. The study coordinators will collect health information over
      three years. They will collect information every week for 100 days, then at 6 months, 1 year,
      2 years, and 3 years.
    

Intervention name(s): Stem Cell Transplant; Cyclophosphamide + Mesna; Melphalan; Granulocyte-colony stimulating factor
Intervention type(s): Procedure; Drug; Drug; Biological
Intervention description(s): As part of the stem cell transplant process, patients receive high doses of chemotherapy and/or radiation to treat their underlying disease, such as cancer. As one of its effects, this treatment also kills the healthy stem cells that are already in the marrow. The transplant provides new stem cells for the patient from a healthy donor; that replace the bone marrow and allow the blood counts to recover.; Cyclophosphamide: 4mg/m^2 + Mesna. Mesna is used to reduce the undesired side effects of certain chemotherapy drugs.; Administered intravenously 200 mg/m^2; Administered intravenously 10 ug/kg/day pretransplant then 5 ug/kg/day post-transplant.
Other intervention name(s): Bone Marrow Transplant; Cytoxan; Alkeran; G-CSF
Intervention MeSH terms: Cyclophosphamide; Melphalan; Lenograstim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stem cell transplantation; chemotherapy; multiple myeloma; autologous