Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
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To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.
Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.
Secondary Outcome Measures :
Evaluation of engraftment of leucocytes and platelets
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 66 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Multiple Myeloma Stadium II / III acc. to Salmon and Durie
signed informed consent
adequate organ function prior autologous respectively allogeneic SCT
availability of HLA-identical related or unrelated donor
availability of at least 2 x 10^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10^6 CD34+ cells for allogeneic SCT
for MRD-SCT: 18-66 years; for MUD-SCT: 18-55 years
at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky
consent of donor to give DLI
severe heart insufficiency
cardiovascular diseases or severe concomitant diseases
active infections that need antibiotic therapy
positive for HIV or hepatitis
malign secondary disease
limited liver function with total bilirubin > 1.5 ULN
increased transaminase > 3 ULN
increased serum creatinine > 2 mg/dl
pregnant or lactating women
known hypersensitivity to Fludarabine or Melphalan