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Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2007 by University of Wuerzburg.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT00546988
First received: October 17, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose
The study is evaluating whether risk-stratification by the means of a chromosomal aberration provides a tool to discriminate between standard and high risk. Risk-adapted therapy is based on allogeneic stem-cell transplantation for high-risk subjects instead of a second autograft in patients with deletion of chromosome 13 who have an HLA-identical stem cell donor available.

Condition Intervention Phase
Multiple Myeloma
Biological: allogeneic stem cell transplant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III

Resource links provided by NLM:


Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:
  • Response rate after high-dose therapy [ Time Frame: one year ]

Secondary Outcome Measures:
  • Response rate and treatment-related mortality after allogeneic transplantation [ Time Frame: one year ]

Estimated Enrollment: 600
Study Start Date: October 2001
Estimated Study Completion Date: January 2008
Arms Assigned Interventions
No Intervention: Standard risk IFN
Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation
No Intervention: Standard risk PEGIFN
Maintenance treatment with pegylated interferon following autologous stem cell transplantation
Experimental: High risk allo
Allogeneic stem cell transplantation from an HLA identical related or unrelated donor
Biological: allogeneic stem cell transplant
No Intervention: High risk auto
Second cycle of high-dose melphalan in subjects without an HLA-identical donor

Detailed Description:
The DSMM V protocol is to compare a consolidation treatment for standard-risk patients not displaying del(13) at initial diagnosis following two cycles of high-dose melphalan 200 mg/m² each supported by autologous stem cell retransfusion with interferon versus PEG-interferon. Patients with del(13) are screened for availability of a fully HLA-matched related or unrelated donor. If patient's informed consent is obtained additionally, he is scheduled to undergo an allogeneic SCT following the first cycle of high-dose melphalan. All other subjects are to proceed to a second course of high-dose melphalan similar to the standard-risk group. Initial cytoreduction is foreseen with four cycles of anthracycline-dexamethasone combination followed by combination therapy with ifosfamide/epirubicine/etoposide for stem-cell collection.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of multiple myeloma
  • Salmon-and-Durie stage II or III
  • Less than or equal to 60 years
  • Signed informed consent

Exclusion Criteria:

  • Relevant comorbidities
  • Unable to adhere to study protocol
  • Pregnancy
  • Not received subject's informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546988

Locations
Austria
Medizinische Univ.-Klinik Graz
Graz, Austria, 8036
Klin. Abt. für Onkologie, AKH Wien
Vienna, Austria, 1090
Germany
Staedtisches Klinikum
Augsburg, Germany, 86156
Dept. of Hematology/Oncology, Charité Berlin
Berlin, Germany, 10098
Charité University Medicine
Berlin, Germany, 10117
University Hospital
Erlangen, Germany, 91054
Krankenhaus Nordwest
Frankfurt, Germany, 60488
Freiburg University Hospital
Freiburg, Germany, 79106
Georg August University Hospital
Gottingen, Germany, 37075
Ernst-Moritz Arndt University Hospital
Greifswald, Germany, 17478
Martin-Luther University Hospital
Halle/Saale, Germany, 06120
University Hospital Eppendorf
Hamburg, Germany, 20246
Hannover Medical School
Hannover, Germany
Saarland University Hospital
Homburg/Saar, Germany, 66421
Schleswig-Holstein University Hospital
Lubeck, Germany, 23538
Mainz University Hospital
Mainz, Germany, 55131
Dept. of Internal Medicine A, University Muenster
Muenster, Germany, 48129
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, Germany, 80336
Klinikum rechts der Isar
Munich, Germany, 81675
Nuremberg Central Hospital
Nuremberg, Germany
Oldenburg Hospital
Oldenburg, Germany, 26133
University Hospital
Regensburg, Germany, 93053
Katharinenhospital
Stuttgart, Germany, 70173
Diakonissenkrankenhaus
Stuttgart, Germany, 70176
Tubingen University Hospital
Tubingen, Germany, 72076
Dept. of Internal Medicine III, University of Ulm
Ulm, Germany, 89081
Ulm University Hospital
Ulm, Germany, 89081
Horst-Schmidt-Kliniken
Wiesbaden, Germany, 65199
Dept. of Internal Medicine II, University of Wuerzburg
Wuerzburg, Germany, 97070
Sponsors and Collaborators
University of Wuerzburg
Investigators
Principal Investigator: Hermann Einsele, M.D. Wuerzburg University Hospital, Dept. of Hematology and Oncology
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00546988     History of Changes
Other Study ID Numbers: DSMM V 
Study First Received: October 17, 2007
Last Updated: October 17, 2007
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:
primary treatment
allogeneic stem-cell transplantation
high-dose therapy
cytogenetics

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

ClinicalTrials.gov processed this record on December 06, 2016