Multiple Myeloma Clinical Trial
Official title:
Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 66 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - participation in another trial |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Yes | ||
Secondary | Evaluation of engraftment of leucocytes and platelets | Yes | ||
Secondary | Evaluation of incidence of acute and chronic GvHD | Yes | ||
Secondary | Evaluation of infectious complications | Yes | ||
Secondary | Evaluation of the effects of DLI in case of no CR | Yes | ||
Secondary | Evaluation of disease-free and overall survival | Yes |
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