Multiple MyelomaPhase 3NCT00546988
Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years
A Phase 3 study testing allogeneic stem cell transplant in people with Multiple Myeloma, run by University of Wuerzburg at 29 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- allogeneic stem cell transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 29 sitesin 2 countries
- Study dates
- Oct 2001to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Primary diagnosis of multiple myeloma
- Salmon-and-Durie stage II or III
- Less than or equal to 60 years
- Signed informed consent
Who cannot join
- Relevant comorbidities
- Unable to adhere to study protocol
- Pregnancy
- Not received subject's informed consent
Trial locations and contacts
29 sites in 2 countries.
29 sites in 2 countries
Germany27 sites, 27 recruiting
- Recruiting
Staedtisches Klinikum
Augsburg, 86156
- Recruiting
Dept. of Hematology/Oncology, Charité Berlin
Berlin, 10098
Orhan Sezer, MD, 030/450-513105, sezer@charite.de
Orhan Sezer, MD
- Recruiting
Charité University Medicine
Berlin, 10117
Orhan Sezer, M.D., orhan.sezer@charite.de
- Recruiting
University Hospital
Erlangen, 91054
- Recruiting
Krankenhaus Nordwest
Frankfurt, 60488
- Recruiting
Freiburg University Hospital
Freiburg im Breisgau, 79106
Monika Engelhardt, M.D., enghelhardtm@mm11ukl.uni-freiburg.de
- Recruiting
Georg August University Hospital
Göttingen, 37075
- Recruiting
Ernst-Moritz Arndt University Hospital
Greifswald, 17478
- Recruiting
Martin-Luther University Hospital
Halle, 06120
Hans H Wolf, M.D., hans.wolf@medizin.uni-halle.de
- Recruiting
University Hospital Eppendorf
Hamburg, 20246
- Recruiting
Hannover Medical School
Hanover
Dietrich Peest, M.D., +49/511-532-0 ext. -27765, Peest.Dietrich@MH-Hannover.de
- Recruiting
Saarland University Hospital
Homburg/Saar, 66421
Michael Pfreundschuh, M.D., +49/6841-162-0 ext. 3003, michael.pfreundschuh@uniklinik-saarland.de
- Recruiting
Schleswig-Holstein University Hospital
Lübeck, 23538
- Recruiting
Mainz University Hospital
Mainz, 55131
- Recruiting
Dept. of Internal Medicine, Ludwig-Maximilian-University Munich
Munich, 80336
Christian Straka, MD, 089/5160-2278, cstraka@medinn.med.uni-muenchen.de
Christian Straka, MD
- Recruiting
Klinikum rechts der Isar
Munich, 81675
- Recruiting
Dept. of Internal Medicine A, University Muenster
Münster, 48129
Martin Kropff, MD, kropff@uni-muenster.de
Martin Kropff, MD
- Recruiting
Nuremberg Central Hospital
Nuremberg
Hannes Wandt, M.D., +49/911/398-0 ext. 3090, wandt@klinikum.nuernberg.de
- Recruiting
Oldenburg Hospital
Oldenburg, 26133
Bernd, Metzner, +49/441/403-0 ext. 2376, metzner.bernd@klinikum-oldenburg.de
- Recruiting
University Hospital
Regensburg, 93053
- Recruiting
Katharinenhospital
Stuttgart, 70173
Hans G Mergenthaler, M.D., +49/711/253-0 ext. 2501, hmergenthaler@buergerhospital.de
- Recruiting
Diakonissenkrankenhaus
Stuttgart, 70176
- Recruiting
Tubingen University Hospital
Tübingen, 72076
Katja Weisel, M.D., +49/7071/29-0 ext. -82711, katja.weisel@med.uni-tuebingen.de
- Recruiting
Dept. of Internal Medicine III, University of Ulm
Ulm, 89081
Peter Liebisch, MD, 0731/500-33809, peter.liebisch@medizin.uni-ulm.de
Peter Liebisch, MD
- Recruiting
Ulm University Hospital
Ulm, 89081
- Recruiting
Horst-Schmidt-Kliniken
Wiesbaden, 65199
Norbert Frickhofen, M.D., +49/611/43-0 ext. 3009, norbert.frickhofen@hsk-wiesbaden.de
- Recruiting
Dept. of Internal Medicine II, University of Wuerzburg
Würzburg, 97070
Hermann Einsele, MD, +4993120170011, einsele_h@klinik.uni-wuerzburg.de
Volker Kunzmann, MD
Austria2 sites, 2 recruiting
- Recruiting
Medizinische Univ.-Klinik Graz
Graz, 8036
Werner Linkesch, MD, ++43(0)316/385-4086, werner.linkesch@kfunigraz.ac
Werner Linkesch, MD
- Recruiting
Klin. Abt. für Onkologie, AKH Wien
Vienna, 1090
Johannes Drach, MD, heinz.gisslinger@akh-wien.ac.at
Johannes Drach, MD
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- allogeneic stem cell transplant
- Keywords
- primary treatment, allogeneic stem-cell transplantation, high-dose therapy, cytogenetics
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic stem cell transplantBiological
| Study group | Role | What they receive |
|---|---|---|
| Standard risk IFN | No intervention | Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation |
| Standard risk PEGIFN | No intervention | Maintenance treatment with pegylated interferon following autologous stem cell transplantation |
| High risk allo | Experimental | Allogeneic stem cell transplantation from an HLA identical related or unrelated donor Receives: Biological: allogeneic stem cell transplant |
| High risk auto | No intervention | Second cycle of high-dose melphalan in subjects without an HLA-identical donor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate after high-dose therapy
Measured: one year
Secondary outcomes (1)
Response rate and treatment-related mortality after allogeneic transplantation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2007 (estimated)
- Study startOct 2001
- Study completionJan 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Investigators
- Hermann Einsele, M.D., Principal investigator, Wuerzburg University Hospital, Dept. of Hematology and Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546988
- Sponsor's protocol ID
- DSMM V
- Status last verified
- Oct 2007
- First submitted
- 17 Oct 2007
- Last updated
- 19 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00546988
- Acronym / sponsor ID
- DSMM V
- Conditions
- Multiple Myeloma
- Keywords
- primary treatment, allogeneic stem-cell transplantation, high-dose therapy, cytogenetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- Oct 2001
- Study completion
- Jan 2008 (estimated)
- First posted
- 19 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Standard risk IFN | No intervention | –Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation |
| Standard risk PEGIFN | No intervention | –Maintenance treatment with pegylated interferon following autologous stem cell transplantation |
| High risk allo | Experimental | Biological: allogeneic stem cell transplantAllogeneic stem cell transplantation from an HLA identical related or unrelated donor |
| High risk auto | No intervention | –Second cycle of high-dose melphalan in subjects without an HLA-identical donor |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Primary diagnosis of multiple myeloma
- Salmon-and-Durie stage II or III
- Less than or equal to 60 years
- Signed informed consent
Key exclusion criteria (4 listed)
- Relevant comorbidities
- Unable to adhere to study protocol
- Pregnancy
- Not received subject's informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic stem cell transplant | Biological | High risk allo |
Primary outcome
Response rate after high-dose therapy
Time frame: one year
1 secondary outcome
Response rate and treatment-related mortality after allogeneic transplantation
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2007.
- Site of the German association of the leading research groups in lymphoid malignanciesLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hermann Einsele, M.D. principal investigator
Wuerzburg University Hospital, Dept. of Hematology and Oncology
29 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing allogeneic stem cell transplant in people with Multiple Myeloma, run by University of Wuerzburg at 29 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hermann Einsele, M.D. (+49/931/201-0 ext. 70015, einsele_h@klinik.uni-wuerzburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate after high-dose therapy (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2007.