Status:
COMPLETED
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
Lead Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Conditions:
Multiple Myeloma
Stem Cell Transplantation
Eligibility:
All Genders
18-66 years
Phase:
PHASE2
Brief Summary
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 don...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00781170
Start Date
May 1 2000
Last Update
May 28 2009
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