We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00546988
Recruitment Status : Unknown
Verified October 2007 by University of Wuerzburg.
Recruitment status was:  Recruiting
First Posted : October 19, 2007
Last Update Posted : October 19, 2007
Information provided by:
University of Wuerzburg

Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Myeloma Biological: allogeneic stem cell transplant Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2001
Estimated Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00546988

Layout table for location contacts
Contact: Hermann Einsele, M.D. +49/931/201-0 ext 70015 einsele_h@klinik.uni-wuerzburg.de
Contact: Stefan Knop, M.D. +49/931/201-0 ext 70368 knop_s@klinik.uni-wuerzburg.de

Show Show 29 study locations
Sponsors and Collaborators
University of Wuerzburg
Layout table for investigator information
Principal Investigator: Hermann Einsele, M.D. Wuerzburg University Hospital, Dept. of Hematology and Oncology
Additional Information:
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00546988    
Other Study ID Numbers: DSMM V
First Posted: October 19, 2007    Key Record Dates
Last Update Posted: October 19, 2007
Last Verified: October 2007
Keywords provided by University of Wuerzburg:
primary treatment
allogeneic stem-cell transplantation
high-dose therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases