Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years - Full Text View

Purpose

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.

Condition	Intervention	Phase
Multiple Myeloma	Biological: allogeneic stem cell transplant	Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Multiple Myeloma

U.S. FDA Resources

Further study details as provided by University of Wuerzburg:

Primary Outcome Measures:

Response rate after high-dose therapy [ Time Frame: one year ]

Secondary Outcome Measures:

Response rate and treatment-related mortality after allogeneic transplantation [ Time Frame: one year ]

Estimated Enrollment:	600
Study Start Date:	October 2001
Estimated Study Completion Date:	January 2008

Arms	Assigned Interventions
No Intervention: Standard risk IFN Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation
No Intervention: Standard risk PEGIFN Maintenance treatment with pegylated interferon following autologous stem cell transplantation
Experimental: High risk allo Allogeneic stem cell transplantation from an HLA identical related or unrelated donor	Biological: allogeneic stem cell transplant
No Intervention: High risk auto Second cycle of high-dose melphalan in subjects without an HLA-identical donor

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

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00546988

Contacts

Contact: Hermann Einsele, M.D.	+49/931/201-0 ext 70015	einsele_h@klinik.uni-wuerzburg.de
Contact: Stefan Knop, M.D.	+49/931/201-0 ext 70368	knop_s@klinik.uni-wuerzburg.de

Locations

Austria
Medizinische Univ.-Klinik Graz	Recruiting
Graz, Austria, 8036
Contact: Werner Linkesch, MD ++43(0)316/385-4086 werner.linkesch@kfunigraz.ac
Principal Investigator: Werner Linkesch, MD
Klin. Abt. für Onkologie, AKH Wien	Recruiting
Vienna, Austria, 1090
Contact: Johannes Drach, MD heinz.gisslinger@akh-wien.ac.at
Principal Investigator: Johannes Drach, MD
Germany
Staedtisches Klinikum	Recruiting
Augsburg, Germany, 86156
Dept. of Hematology/Oncology, Charité Berlin	Recruiting
Berlin, Germany, 10098
Contact: Orhan Sezer, MD 030/450-513105 sezer@charite.de
Principal Investigator: Orhan Sezer, MD
Charité University Medicine	Recruiting
Berlin, Germany, 10117
Contact: Orhan Sezer, M.D. orhan.sezer@charite.de
University Hospital	Recruiting
Erlangen, Germany, 91054
Krankenhaus Nordwest	Recruiting
Frankfurt, Germany, 60488
Freiburg University Hospital	Recruiting
Freiburg, Germany, 79106
Contact: Monika Engelhardt, M.D. enghelhardtm@mm11ukl.uni-freiburg.de
Georg August University Hospital	Recruiting
Gottingen, Germany, 37075
Ernst-Moritz Arndt University Hospital	Recruiting
Greifswald, Germany, 17478
Martin-Luther University Hospital	Recruiting
Halle/Saale, Germany, 06120
Contact: Hans H Wolf, M.D. hans.wolf@medizin.uni-halle.de
University Hospital Eppendorf	Recruiting
Hamburg, Germany, 20246
Hannover Medical School	Recruiting
Hannover, Germany
Contact: Dietrich Peest, M.D. +49/511-532-0 ext -27765 Peest.Dietrich@MH-Hannover.de
Saarland University Hospital	Recruiting
Homburg/Saar, Germany, 66421
Contact: Michael Pfreundschuh, M.D. +49/6841-162-0 ext 3003 michael.pfreundschuh@uniklinik-saarland.de
Schleswig-Holstein University Hospital	Recruiting
Lubeck, Germany, 23538
Mainz University Hospital	Recruiting
Mainz, Germany, 55131
Dept. of Internal Medicine A, University Muenster	Recruiting
Muenster, Germany, 48129
Contact: Martin Kropff, MD kropff@uni-muenster.de
Sub-Investigator: Martin Kropff, MD
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich	Recruiting
Munich, Germany, 80336
Contact: Christian Straka, MD 089/5160-2278 cstraka@medinn.med.uni-muenchen.de
Principal Investigator: Christian Straka, MD
Klinikum rechts der Isar	Recruiting
Munich, Germany, 81675
Nuremberg Central Hospital	Recruiting
Nuremberg, Germany
Contact: Hannes Wandt, M.D. +49/911/398-0 ext 3090 wandt@klinikum.nuernberg.de
Oldenburg Hospital	Recruiting
Oldenburg, Germany, 26133
Contact: Bernd , Metzner +49/441/403-0 ext 2376 metzner.bernd@klinikum-oldenburg.de
University Hospital	Recruiting
Regensburg, Germany, 93053
Diakonissenkrankenhaus	Recruiting
Stuttgart, Germany, 70176
Katharinenhospital	Recruiting
Stuttgart, Germany, 70173
Contact: Hans G Mergenthaler, M.D. +49/711/253-0 ext 2501 hmergenthaler@buergerhospital.de
Tubingen University Hospital	Recruiting
Tubingen, Germany, 72076
Contact: Katja Weisel, M.D. +49/7071/29-0 ext -82711 katja.weisel@med.uni-tuebingen.de
Dept. of Internal Medicine III, University of Ulm	Recruiting
Ulm, Germany, 89081
Contact: Peter Liebisch, MD 0731/500-33809 peter.liebisch@medizin.uni-ulm.de
Principal Investigator: Peter Liebisch, MD
Ulm University Hospital	Recruiting
Ulm, Germany, 89081
Horst-Schmidt-Kliniken	Recruiting
Wiesbaden, Germany, 65199
Contact: Norbert Frickhofen, M.D. +49/611/43-0 ext 3009 norbert.frickhofen@hsk-wiesbaden.de
Dept. of Internal Medicine II, University of Wuerzburg	Recruiting
Wuerzburg, Germany, 97070
Contact: Hermann Einsele, MD +4993120170011 einsele_h@klinik.uni-wuerzburg.de
Sub-Investigator: Volker Kunzmann, MD
Sub-Investigator: Stefan Knop, MD

Sponsors and Collaborators

University of Wuerzburg

Investigators

Principal Investigator:

Hermann Einsele, M.D.

Wuerzburg University Hospital, Dept. of Hematology and Oncology

More Information

Additional Information:

Site of the German association of the leading research groups in lymphoid malignancies This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00546988 History of Changes
Other Study ID Numbers:	DSMM V
Study First Received:	October 17, 2007
Last Updated:	October 17, 2007
Health Authority:	Germany: Ethics Commission Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Wuerzburg:

primary treatment
allogeneic stem-cell transplantation
high-dose therapy
cytogenetics

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases

Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013