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

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ClinicalTrials.gov Identifier: NCT00781170
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : May 28, 2009
Sponsor:
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

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
U.S. FDA Resources




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


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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00781170


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dr. N. Kroeger, University Medical Center Hamburg-Eppendorf
ClinicalTrials.gov 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
Plasmocytoma
Stem Cell Transplantation

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases