Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
NCT ID: NCT00781170
Last Updated: 2009-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2000-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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allogeneic hematopoietic SCT
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
66 Years
ALL
No
Sponsors
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Universitätsklinikum Hamburg-Eppendorf
OTHER
Responsible Party
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University Medical Center Hamburg-Eppendorf
Principal Investigators
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Nicolaus Kroeger, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Hamburg-Eppendorf, Germany
References
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Kroger N, Badbaran A, Zabelina T, Ayuk F, Wolschke C, Alchalby H, Klyuchnikov E, Atanackovic D, Schilling G, Hansen T, Schwarz S, Heinzelmann M, Zeschke S, Bacher U, Stubig T, Fehse B, Zander AR. Impact of high-risk cytogenetics and achievement of molecular remission on long-term freedom from disease after autologous-allogeneic tandem transplantation in patients with multiple myeloma. Biol Blood Marrow Transplant. 2013 Mar;19(3):398-404. doi: 10.1016/j.bbmt.2012.10.008. Epub 2012 Oct 16.
Other Identifiers
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Auto/Allo Plasmozytom
Identifier Type: -
Identifier Source: org_study_id