Multi Centre Trial of DSMM for Newly Diagnosed Multiple Myeloma up to 60 Years
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| ClinicalTrials.gov Identifier: NCT00546988 |
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Recruitment Status : Unknown
Verified October 2007 by University of Wuerzburg.
Recruitment status was: Recruiting
First Posted : October 19, 2007
Last Update Posted : October 19, 2007
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Sponsor:
University of Wuerzburg
Information provided by:
University of Wuerzburg
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multiple Myeloma | Biological: allogeneic stem cell transplant | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 600 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | October 2001 |
| Estimated Study Completion Date : | January 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
MedlinePlus related topics:
Multiple Myeloma
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard risk IFN
Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation
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No Intervention: Standard risk PEGIFN
Maintenance treatment with pegylated interferon following autologous stem cell transplantation
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Experimental: High risk allo
Allogeneic stem cell transplantation from an HLA identical related or unrelated donor
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Biological: allogeneic stem cell transplant |
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No Intervention: High risk auto
Second cycle of high-dose melphalan in subjects without an HLA-identical donor
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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 ]
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Show 29 study locations
Sponsors and Collaborators
University of Wuerzburg
Investigators
| Principal Investigator: | Hermann Einsele, M.D. | Wuerzburg University Hospital, Dept. of Hematology and Oncology |
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00546988 |
| Other Study ID Numbers: |
DSMM V |
| First Posted: | October 19, 2007 Key Record Dates |
| Last Update Posted: | October 19, 2007 |
| Last Verified: | October 2007 |
Keywords provided by University of Wuerzburg:
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primary treatment allogeneic stem-cell transplantation high-dose therapy cytogenetics |
Additional relevant MeSH terms:
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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 |