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

  • STATUS
    Recruiting
  • participants needed
    600
  • sponsor
    University of Wuerzburg
Updated on 7 November 2020
cell transplantation
autograft

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.

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.

Details
Condition Multiple Myeloma
Treatment Allogeneic stem cell transplant
Clinical Study IdentifierNCT00546988
SponsorUniversity of Wuerzburg
Last Modified on7 November 2020

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