search
Back to results

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

Primary Purpose

Multiple Myeloma

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
allogeneic stem cell transplant
Sponsored by
University of Wuerzburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring primary treatment, allogeneic stem-cell transplantation, high-dose therapy, cytogenetics

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Univ.-Klinik GrazRecruiting
  • Klin. Abt. für Onkologie, AKH WienRecruiting
  • Staedtisches KlinikumRecruiting
  • Dept. of Hematology/Oncology, Charité BerlinRecruiting
  • Charité University MedicineRecruiting
  • University HospitalRecruiting
  • Krankenhaus NordwestRecruiting
  • Freiburg University HospitalRecruiting
  • Georg August University HospitalRecruiting
  • Ernst-Moritz Arndt University HospitalRecruiting
  • Martin-Luther University HospitalRecruiting
  • University Hospital EppendorfRecruiting
  • Hannover Medical SchoolRecruiting
  • Saarland University HospitalRecruiting
  • Schleswig-Holstein University HospitalRecruiting
  • Mainz University HospitalRecruiting
  • Dept. of Internal Medicine A, University MuensterRecruiting
  • Dept. of Internal Medicine, Ludwig-Maximilian-University MunichRecruiting
  • Klinikum rechts der IsarRecruiting
  • Nuremberg Central HospitalRecruiting
  • Oldenburg HospitalRecruiting
  • University HospitalRecruiting
  • KatharinenhospitalRecruiting
  • DiakonissenkrankenhausRecruiting
  • Tubingen University HospitalRecruiting
  • Dept. of Internal Medicine III, University of UlmRecruiting
  • Ulm University HospitalRecruiting
  • Horst-Schmidt-KlinikenRecruiting
  • Dept. of Internal Medicine II, University of WuerzburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

No Intervention

Arm Label

Standard risk IFN

Standard risk PEGIFN

High risk allo

High risk auto

Arm Description

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

Maintenance treatment with pegylated interferon following autologous stem cell transplantation

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

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

Outcomes

Primary Outcome Measures

Response rate after high-dose therapy

Secondary Outcome Measures

Response rate and treatment-related mortality after allogeneic transplantation

Full Information

First Posted
October 17, 2007
Last Updated
October 17, 2007
Sponsor
University of Wuerzburg
search

1. Study Identification

Unique Protocol Identification Number
NCT00546988
Brief Title
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

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Wuerzburg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
primary treatment, allogeneic stem-cell transplantation, high-dose therapy, cytogenetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard risk IFN
Arm Type
No Intervention
Arm Description
Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation
Arm Title
Standard risk PEGIFN
Arm Type
No Intervention
Arm Description
Maintenance treatment with pegylated interferon following autologous stem cell transplantation
Arm Title
High risk allo
Arm Type
Experimental
Arm Description
Allogeneic stem cell transplantation from an HLA identical related or unrelated donor
Arm Title
High risk auto
Arm Type
No Intervention
Arm Description
Second cycle of high-dose melphalan in subjects without an HLA-identical donor
Intervention Type
Biological
Intervention Name(s)
allogeneic stem cell transplant
Primary Outcome Measure Information:
Title
Response rate after high-dose therapy
Time Frame
one year
Secondary Outcome Measure Information:
Title
Response rate and treatment-related mortality after allogeneic transplantation
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hermann Einsele, M.D.
Phone
+49/931/201-0
Ext
70015
Email
einsele_h@klinik.uni-wuerzburg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Knop, M.D.
Phone
+49/931/201-0
Ext
70368
Email
knop_s@klinik.uni-wuerzburg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermann Einsele, M.D.
Organizational Affiliation
Wuerzburg University Hospital, Dept. of Hematology and Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Univ.-Klinik Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Werner Linkesch, MD
Phone
++43(0)316/385-4086
Email
werner.linkesch@kfunigraz.ac
First Name & Middle Initial & Last Name & Degree
Werner Linkesch, MD
Facility Name
Klin. Abt. für Onkologie, AKH Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Johannes Drach, MD
Email
heinz.gisslinger@akh-wien.ac.at
First Name & Middle Initial & Last Name & Degree
Johannes Drach, MD
Facility Name
Staedtisches Klinikum
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dept. of Hematology/Oncology, Charité Berlin
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orhan Sezer, MD
Phone
030/450-513105
Email
sezer@charite.de
First Name & Middle Initial & Last Name & Degree
Orhan Sezer, MD
Facility Name
Charité University Medicine
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Orhan Sezer, M.D.
Email
orhan.sezer@charite.de
Facility Name
University Hospital
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Krankenhaus Nordwest
City
Frankfurt
ZIP/Postal Code
60488
Country
Germany
Individual Site Status
Recruiting
Facility Name
Freiburg University Hospital
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monika Engelhardt, M.D.
Email
enghelhardtm@mm11ukl.uni-freiburg.de
Facility Name
Georg August University Hospital
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Ernst-Moritz Arndt University Hospital
City
Greifswald
ZIP/Postal Code
17478
Country
Germany
Individual Site Status
Recruiting
Facility Name
Martin-Luther University Hospital
City
Halle/Saale
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans H Wolf, M.D.
Email
hans.wolf@medizin.uni-halle.de
Facility Name
University Hospital Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dietrich Peest, M.D.
Phone
+49/511-532-0
Ext
-27765
Email
Peest.Dietrich@MH-Hannover.de
Facility Name
Saarland University Hospital
City
Homburg/Saar
ZIP/Postal Code
66421
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Pfreundschuh, M.D.
Phone
+49/6841-162-0
Ext
3003
Email
michael.pfreundschuh@uniklinik-saarland.de
Facility Name
Schleswig-Holstein University Hospital
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Mainz University Hospital
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Recruiting
Facility Name
Dept. of Internal Medicine A, University Muenster
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Kropff, MD
Email
kropff@uni-muenster.de
First Name & Middle Initial & Last Name & Degree
Martin Kropff, MD
Facility Name
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Straka, MD
Phone
089/5160-2278
Email
cstraka@medinn.med.uni-muenchen.de
First Name & Middle Initial & Last Name & Degree
Christian Straka, MD
Facility Name
Klinikum rechts der Isar
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Nuremberg Central Hospital
City
Nuremberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannes Wandt, M.D.
Phone
+49/911/398-0
Ext
3090
Email
wandt@klinikum.nuernberg.de
Facility Name
Oldenburg Hospital
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernd, Metzner
Phone
+49/441/403-0
Ext
2376
Email
metzner.bernd@klinikum-oldenburg.de
Facility Name
University Hospital
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
Katharinenhospital
City
Stuttgart
ZIP/Postal Code
70173
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans G Mergenthaler, M.D.
Phone
+49/711/253-0
Ext
2501
Email
hmergenthaler@buergerhospital.de
Facility Name
Diakonissenkrankenhaus
City
Stuttgart
ZIP/Postal Code
70176
Country
Germany
Individual Site Status
Recruiting
Facility Name
Tubingen University Hospital
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katja Weisel, M.D.
Phone
+49/7071/29-0
Ext
-82711
Email
katja.weisel@med.uni-tuebingen.de
Facility Name
Dept. of Internal Medicine III, University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Liebisch, MD
Phone
0731/500-33809
Email
peter.liebisch@medizin.uni-ulm.de
First Name & Middle Initial & Last Name & Degree
Peter Liebisch, MD
Facility Name
Ulm University Hospital
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Horst-Schmidt-Kliniken
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Frickhofen, M.D.
Phone
+49/611/43-0
Ext
3009
Email
norbert.frickhofen@hsk-wiesbaden.de
Facility Name
Dept. of Internal Medicine II, University of Wuerzburg
City
Wuerzburg
ZIP/Postal Code
97070
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermann Einsele, MD
Phone
+4993120170011
Email
einsele_h@klinik.uni-wuerzburg.de
First Name & Middle Initial & Last Name & Degree
Volker Kunzmann, MD
First Name & Middle Initial & Last Name & Degree
Stefan Knop, MD

12. IPD Sharing Statement

Links:
URL
http://www.lymphome.de
Description
Site of the German association of the leading research groups in lymphoid malignancies

Learn more about this trial

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

We'll reach out to this number within 24 hrs