Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma - Full Text View

Sponsored by:	Universitätsklinikum Hamburg-Eppendorf
Information provided by:	Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:	NCT00781170

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma Stem Cell Transplantation	Procedure: allogeneic hematopoietic SCT	Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

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. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Evaluation of engraftment of leucocytes and platelets [ Designated as safety issue: Yes ]
Evaluation of incidence of acute and chronic GvHD [ Designated as safety issue: Yes ]
Evaluation of infectious complications [ Designated as safety issue: Yes ]
Evaluation of the effects of DLI in case of no CR [ Designated as safety issue: Yes ]
Evaluation of disease-free and overall survival [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	May 2000

Eligibility

Ages Eligible for Study:	18 Years to 66 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781170

Sponsors and Collaborators

Universitätsklinikum Hamburg-Eppendorf

Investigators

Principal Investigator:

Nicolaus Kroeger, Prof. Dr.

University Medical Center Hamburg-Eppendorf, Germany

More Information

Responsible Party:	University Medical Center Hamburg-Eppendorf ( Prof. Dr. N. Kroeger )
Study ID Numbers:	Auto/Allo Plasmozytom
Study First Received:	October 22, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00781170
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: Paul-Ehrlich-Institut

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:

Multiple Myeloma
Plasmocytoma
Stem Cell Transplantation

Study placed in the following topic categories:

Immunoproliferative Disorders
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders

Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Plasmacytoma
Plasmacytoma anaplastic
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009