Auto-Allo Tandem Stem Cell Transplantation for Patients With Multiple Myeloma

Last updated: October 26, 2023
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Overall Status: Completed

Phase

2

Condition

Platelet Disorders

Multiple Myeloma

Lymphoproliferative Disorders

Treatment

auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide

Auto-Allo Tandem SCT and maintenance therapy with Thalidomide/ DLI

Clinical Study ID

NCT00777998
Auto-Allo TSCT in MM
  • Ages 18-60
  • All Genders

Study Summary

The present study will be a multicenter, prospective phase II-study investigating safety and efficacy of the combination of auto-allo tandem stem cell transplantation in patients with multiple myeloma and age of >_60 years, followed by maintenance therapy with low-dose Thalidomide and Donor Lymphocyte Infusions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Multiple Myeloma Stage II or III acc. to Salmon and Durie
  • Patient's age 18-60 years
  • Patient's written informed consent
  • Women and men capable of reproduction must agree to use adequate contraceptivemeasures (condom, IUD, oral contraceptives) until three months after termination oftreatment
  • a maximum of eight chemotherapy cycles prior to registration (CR/ PR/ MR/ or PD)

Exclusion

Exclusion Criteria:

  • More than eight chemotherapy cycles prior to registration
  • severe irreversible renal, hepatic, pulmonary or cardiac disease, such as
  • total bilirubin, SGPT or SGOT > 3 times upper the normal level
  • Left ventricular ejection fraction < 30 %
  • Creatinine Clearance < 30 ml/min
  • DLCO < 35 % and/or receiving supplementary continuous oxygen
  • Positive serology for HIV
  • Pregnant or lactating women
  • Participation in another trial at the time of registration
  • Preceding autologous stem cell transplantation
  • age > 61 years

Study Design

Total Participants: 221
Treatment Group(s): 2
Primary Treatment: auto-auto Tandem stem cell transplantation and maintenance therapy with Thalidomide
Phase: 2
Study Start date:
October 14, 2008
Estimated Completion Date:
June 30, 2021

Connect with a study center

  • Klinikum Augsburg

    Augsburg, 86156
    Germany

    Site Not Available

  • Charité

    Berlin, 12203
    Germany

    Site Not Available

  • Universitätsklinikum Dresden

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen, 91054
    Germany

    Site Not Available

  • Universitätsklinikum Essen

    Essen, 45122
    Germany

    Site Not Available

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), 15236
    Germany

    Site Not Available

  • Universitätsklinikum Greifswald

    Greifswald, 17475
    Germany

    Site Not Available

  • Universitätsklinikum Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitätsklinikum Göttingen

    Göttingen, 37075
    Germany

    Site Not Available

  • Universitätsklinikum Halle (Saale)

    Halle (Saale), 06097
    Germany

    Site Not Available

  • Asklepios Klinik Altona

    Hamburg, 22763
    Germany

    Site Not Available

  • University Medical Center Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitätsklinikum Marburg

    Marburg, 35032
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Site Not Available

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191
    Germany

    Site Not Available

  • Horst Schmidt Kliniken GmbH

    Wiesbaden, 65199
    Germany

    Site Not Available

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