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


Phase 3
18 Years
60 Years
Open (Enrolling)
Both
Multiple Myeloma

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate after high-dose therapy

Outcome Time Frame:

one year

Principal Investigator

Hermann Einsele, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Wuerzburg University Hospital, Dept. of Hematology and Oncology

Authority:

Germany: Ethics Commission

Study ID:

DSMM V

NCT ID:

NCT00546988

Start Date:

October 2001

Completion Date:

January 2008

Related Keywords:

  • Multiple Myeloma
  • primary treatment
  • allogeneic stem-cell transplantation
  • high-dose therapy
  • cytogenetics
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

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