Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years

NCT ID: NCT00546988

Last Updated: 2007-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard risk IFN

Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

Standard risk PEGIFN

Maintenance treatment with pegylated interferon following autologous stem cell transplantation

Group Type NO_INTERVENTION

No interventions assigned to this group

High risk allo

Allogeneic stem cell transplantation from an HLA identical related or unrelated donor

Group Type EXPERIMENTAL

allogeneic stem cell transplant

Intervention Type BIOLOGICAL

High risk auto

Second cycle of high-dose melphalan in subjects without an HLA-identical donor

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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allogeneic stem cell transplant

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wuerzburg

OTHER

Sponsor Role lead

Principal Investigators

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Hermann Einsele, M.D.

Role: PRINCIPAL_INVESTIGATOR

Wuerzburg University Hospital, Dept. of Hematology and Oncology

Locations

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Medizinische Univ.-Klinik Graz

Graz, , Austria

Site Status RECRUITING

Klin. Abt. für Onkologie, AKH Wien

Vienna, , Austria

Site Status RECRUITING

Staedtisches Klinikum

Augsburg, , Germany

Site Status RECRUITING

Dept. of Hematology/Oncology, Charité Berlin

Berlin, , Germany

Site Status RECRUITING

Charité University Medicine

Berlin, , Germany

Site Status RECRUITING

University Hospital

Erlangen, , Germany

Site Status RECRUITING

Krankenhaus Nordwest

Frankfurt, , Germany

Site Status RECRUITING

Freiburg University Hospital

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Georg August University Hospital

Göttingen, , Germany

Site Status RECRUITING

Ernst-Moritz Arndt University Hospital

Greifswald, , Germany

Site Status RECRUITING

Martin-Luther University Hospital

Halle, , Germany

Site Status RECRUITING

University Hospital Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Hannover Medical School

Hanover, , Germany

Site Status RECRUITING

Saarland University Hospital

Homburg/Saar, , Germany

Site Status RECRUITING

Schleswig-Holstein University Hospital

Lübeck, , Germany

Site Status RECRUITING

Mainz University Hospital

Mainz, , Germany

Site Status RECRUITING

Dept. of Internal Medicine, Ludwig-Maximilian-University Munich

Munich, , Germany

Site Status RECRUITING

Klinikum rechts der Isar

Munich, , Germany

Site Status RECRUITING

Dept. of Internal Medicine A, University Muenster

Münster, , Germany

Site Status RECRUITING

Nuremberg Central Hospital

Nuremberg, , Germany

Site Status RECRUITING

Oldenburg Hospital

Oldenburg, , Germany

Site Status RECRUITING

University Hospital

Regensburg, , Germany

Site Status RECRUITING

Katharinenhospital

Stuttgart, , Germany

Site Status RECRUITING

Diakonissenkrankenhaus

Stuttgart, , Germany

Site Status RECRUITING

Tubingen University Hospital

Tübingen, , Germany

Site Status RECRUITING

Dept. of Internal Medicine III, University of Ulm

Ulm, , Germany

Site Status RECRUITING

Ulm University Hospital

Ulm, , Germany

Site Status RECRUITING

Horst-Schmidt-Kliniken

Wiesbaden, , Germany

Site Status RECRUITING

Dept. of Internal Medicine II, University of Wuerzburg

Würzburg, , Germany

Site Status RECRUITING

Countries

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Austria Germany

Central Contacts

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Hermann Einsele, M.D.

Role: CONTACT

Phone: +49/931/201-0

Email: [email protected]

Stefan Knop, M.D.

Role: CONTACT

Phone: +49/931/201-0

Email: [email protected]

Facility Contacts

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Werner Linkesch, MD

Role: primary

Johannes Drach, MD

Role: primary

Orhan Sezer, MD

Role: primary

Orhan Sezer, M.D.

Role: primary

Monika Engelhardt, M.D.

Role: primary

Hans H Wolf, M.D.

Role: primary

Dietrich Peest, M.D.

Role: primary

Michael Pfreundschuh, M.D.

Role: primary

Christian Straka, MD

Role: primary

Martin Kropff, MD

Role: primary

Hannes Wandt, M.D.

Role: primary

Bernd, Metzner

Role: primary

Hans G Mergenthaler, M.D.

Role: primary

Katja Weisel, M.D.

Role: primary

Peter Liebisch, MD

Role: primary

Norbert Frickhofen, M.D.

Role: primary

Hermann Einsele, MD

Role: primary

Related Links

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http://www.lymphome.de

Site of the German association of the leading research groups in lymphoid malignancies

Other Identifiers

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DSMM V

Identifier Type: -

Identifier Source: org_study_id