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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00781170
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : May 28, 2009
Information provided by:
Universitätsklinikum Hamburg-Eppendorf

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Stem Cell Transplantation Procedure: allogeneic hematopoietic SCT Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Primary Outcome Measures :
  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 Outcome Measures :
  1. Evaluation of engraftment of leucocytes and platelets
  2. Evaluation of incidence of acute and chronic GvHD
  3. Evaluation of infectious complications
  4. Evaluation of the effects of DLI in case of no CR
  5. Evaluation of disease-free and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00781170

Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
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Principal Investigator: Nicolaus Kroeger, Prof. Dr. University Medical Center Hamburg-Eppendorf, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Prof. Dr. N. Kroeger, University Medical Center Hamburg-Eppendorf Identifier: NCT00781170     History of Changes
Other Study ID Numbers: Auto/Allo Plasmozytom
First Posted: October 28, 2008    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: May 2009
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Multiple Myeloma
Stem Cell Transplantation
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases