Clinical trial NCT00546988: Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: primary treatment
allogeneic stem-cell transplantation
high-dose therapy
cytogenetics
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2007-10-19
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate after high-dose therapy
timeFrame: one year
Secondary outcomes:
measure: Response rate and treatment-related mortality after allogeneic transplantation
timeFrame: one year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Univ.-Klinik Graz
city: Vienna
country: Austria
facility: Klin. Abt. für Onkologie, AKH Wien
city: Augsburg
country: Germany
facility: Staedtisches Klinikum
city: Berlin
country: Germany
facility: Dept. of Hematology/Oncology, Charité Berlin
city: Berlin
country: Germany
facility: Charité University Medicine
city: Erlangen
country: Germany
facility: University Hospital
city: Frankfurt
country: Germany
facility: Krankenhaus Nordwest
city: Freiburg
country: Germany
facility: Freiburg University Hospital
city: Gottingen
country: Germany
facility: Georg August University Hospital
city: Greifswald
country: Germany
facility: Ernst-Moritz Arndt University Hospital
city: Halle/Saale
country: Germany
facility: Martin-Luther University Hospital
city: Hamburg
country: Germany
facility: University Hospital Eppendorf
city: Hannover
country: Germany
facility: Hannover Medical School
city: Homburg/Saar
country: Germany
facility: Saarland University Hospital
city: Lubeck
country: Germany
facility: Schleswig-Holstein University Hospital
city: Mainz
country: Germany
facility: Mainz University Hospital
city: Muenster
country: Germany
facility: Dept. of Internal Medicine A, University Muenster
city: Munich
country: Germany
facility: Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
city: Munich
country: Germany
facility: Klinikum rechts der Isar
city: Nuremberg
country: Germany
facility: Nuremberg Central Hospital
city: Oldenburg
country: Germany
facility: Oldenburg Hospital
city: Regensburg
country: Germany
facility: University Hospital
city: Stuttgart
country: Germany
facility: Katharinenhospital
city: Stuttgart
country: Germany
facility: Diakonissenkrankenhaus
city: Tubingen
country: Germany
facility: Tubingen University Hospital
city: Ulm
country: Germany
facility: Dept. of Internal Medicine III, University of Ulm
city: Ulm
country: Germany
facility: Ulm University Hospital
city: Wiesbaden
country: Germany
facility: Horst-Schmidt-Kliniken
city: Wuerzburg
country: Germany
facility: Dept. of Internal Medicine II, University of Wuerzburg
Study officials:
affiliation: Wuerzburg University Hospital, Dept. of Hematology and Oncology
name: Hermann Einsele, M.D.
role: PRINCIPAL_INVESTIGATOR
References: