Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Active	18 to 60	Other	DSMM V NCT00546988

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Julius Maximilians Universitaet Hospital

Hermann Einsele, M.D.

Principal Investigator

Hermann Einsele, M.D.		Ph: +49/931/201-0 Ext.70015
		Email: einsele_h@klinik.uni-wuerzburg.de

Stefan Knop, M.D.		Ph: +49/931/201-0 Ext.70368
		Email: knop_s@klinik.uni-wuerzburg.de

Austria
	Graz
	Landeskrankenhaus/Universitatskliniken Graz
		Werner Linkesch, MD	Ph: ++43(0)316/385-4086
			Email: werner.linkesch@kfunigraz.ac
		Werner Linkesch	Principal Investigator
	Vienna
	Allgemeines Krankenhaus - Universitatskliniken
		Johannes Drach, MD
			Email: heinz.gisslinger@akh-wien.ac.at
		Johannes Drach, MD	Principal Investigator
Germany
	Augsburg
	Klinikum Augsburg
	Berlin
	Charite - Campus Charite Mitte
		Orhan Sezer, MD	Ph: 030/450-513105
			Email: sezer@charite.de
		Orhan Sezer	Principal Investigator
		Orhan Sezer, M.D.
			Email: orhan.sezer@charite.de
	Erlangen
	Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen
	Frankfurt
	Krankenhaus Nordwest
	Freiburg
	Universitaetsklinikum Freiburg
		Monika Engelhardt, M.D.
			Email: enghelhardtm@mm11ukl.uni-freiburg.de
	Gottingen
	Georg August Universitaet
	Greifswald
	Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
	Halle/Saale
	Universitaetsklinikum Halle
		Hans H Wolf, M.D.
			Email: hans.wolf@medizin.uni-halle.de
	Hamburg
	University Medical Center Hamburg - Eppendorf
	Hannover
	Medizinische Hochschule Hannover
		Dietrich Peest, M.D.	Ph: +49/511-532-0 Ext.-27765
			Email: Peest.Dietrich@MH-Hannover.de
	Homburg/Saar
	Universitaetsklinikum des Saarlandes
		Michael Pfreundschuh, M.D.	Ph: +49/6841-162-0 Ext.3003
			Email: michael.pfreundschuh@uniklinik-saarland.de
	Lubeck
	Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
	Mainz
	Universitatsklinik Mainz
	Muenster
	University of Muenster
		Martin Kropff, MD
			Email: kropff@uni-muenster.de
		Martin Kropff, MD	Sub-Investigator
	Munich
	I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
		Christian Straka, MD	Ph: 089/5160-2278
			Email: cstraka@medinn.med.uni-muenchen.de
		Christian Straka, MD	Principal Investigator
	Klinikum Rechts Der Isar - Technische Universitaet Muenchen
	Nuremberg
	Klinikum Nuernberg - Klinikum Nord
		Hannes Wandt, M.D.	Ph: +49/911/398-0 Ext.3090
			Email: wandt@klinikum.nuernberg.de
	Oldenburg
	Klinikum Oldenburg
		Bernd , Metzner	Ph: +49/441/403-0 Ext.2376
			Email: metzner.bernd@klinikum-oldenburg.de
	Regensburg
	Klinikum der Universitaet Regensburg
	Stuttgart
	Diakonie Klinikum Stuttgart
	Klinik fuer Onkologie - Katharinenhospital Stuttgart
		Hans G Mergenthaler, M.D.	Ph: +49/711/253-0 Ext.2501
			Email: hmergenthaler@buergerhospital.de
	Tubingen
	Tubingen University Hospital
		Katja Weisel, M.D.	Ph: +49/7071/29-0 Ext.-82711
			Email: katja.weisel@med.uni-tuebingen.de
	Ulm
	Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
		Peter Liebisch, MD	Ph: 0731/500-33809
			Email: peter.liebisch@medizin.uni-ulm.de
		Peter Liebisch, MD	Principal Investigator
	Wiesbaden
	Dr. Horst-Schmidt-Kliniken
		Norbert Frickhofen, M.D.	Ph: +49/611/43-0 Ext.3009
			Email: norbert.frickhofen@hsk-wiesbaden.de
	Wuerzburg
	Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
		Hermann Einsele, MD	Ph: +4993120170011
			Email: einsele_h@klinik.uni-wuerzburg.de
		Volker Kunzmann, MD	Sub-Investigator
		Stefan Knop, MD	Sub-Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00546988
Information obtained from ClinicalTrials.gov on March 18, 2009