Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
1 other identifier
interventional
20
0 countries
N/A
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 multiple-myeloma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
October 22, 2008
CompletedFirst Posted
Study publicly available on registry
October 28, 2008
CompletedMay 28, 2009
May 1, 2009
October 22, 2008
May 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Evaluation of engraftment of leucocytes and platelets
Evaluation of incidence of acute and chronic GvHD
Evaluation of infectious complications
Evaluation of the effects of DLI in case of no CR
Evaluation of disease-free and overall survival
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 23078786DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolaus Kroeger, Prof. Dr.
University Medical Center Hamburg-Eppendorf, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 22, 2008
First Posted
October 28, 2008
Study Start
May 1, 2000
Last Updated
May 28, 2009
Record last verified: 2009-05