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

October 17, 2007 updated by: University of Wuerzburg

Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate after high-dose therapy
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Response rate and treatment-related mortality after allogeneic transplantation
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wuerzburg

Investigators

  • Principal Investigator: Hermann Einsele, M.D., Wuerzburg University Hospital, Dept. of Hematology and Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2001

Study Completion (Anticipated)

January 1, 2008

Study Registration Dates

First Submitted

October 17, 2007

First Submitted That Met QC Criteria

October 17, 2007

First Posted (Estimate)

October 19, 2007

Study Record Updates

Last Update Posted (Estimate)

October 19, 2007

Last Update Submitted That Met QC Criteria

October 17, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSMM V

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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