Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma, Stem Cell Transplantation
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
allogeneic hematopoietic SCT
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00781170
First Posted
October 22, 2008
Last Updated
May 27, 2009
Sponsor
Universitätsklinikum Hamburg-Eppendorf
1. Study Identification
Unique Protocol Identification Number
NCT00781170
Brief Title
Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Universitätsklinikum Hamburg-Eppendorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Stem Cell Transplantation
Keywords
Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
allogeneic hematopoietic SCT
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evaluation of engraftment of leucocytes and platelets
Title
Evaluation of incidence of acute and chronic GvHD
Title
Evaluation of infectious complications
Title
Evaluation of the effects of DLI in case of no CR
Title
Evaluation of disease-free and overall survival
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaus Kroeger, Prof. Dr.
Organizational Affiliation
University Medical Center Hamburg-Eppendorf, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
23078786
Citation
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.
Results Reference
derived
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Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
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