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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
Universitätsklinikum Hamburg-Eppendorf
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation

Eligibility Criteria

18 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 22, 2008
    Last Updated
    May 27, 2009
    Sponsor
    Universitätsklinikum Hamburg-Eppendorf
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    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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