Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate after high-dose therapy
one year
Hermann Einsele, M.D.
Principal Investigator
Wuerzburg University Hospital, Dept. of Hematology and Oncology
Germany: Ethics Commission
DSMM V
NCT00546988
October 2001
January 2008
Name | Location |
---|