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

Phase 3

• Conditions: Multiple Myeloma

• Registration Number: NCT00546988
• Lead Sponsor: University of Wuerzburg

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.

Study Timeline

• Study Start: 2001-10
• Status Verified: 2007-10
• Study First Submitted: 2007-10-17
• Study First Submitted QC: 2007-10-17
• Last Update Submitted: 2007-10-17
• Study First Posted: 2007-10-19
• Last Update Posted: 2007-10-19
• Study Completion: 2008-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Response rate after high-dose therapy	one year

Secondary Outcome Measures

Name	Time	Method
Response rate and treatment-related mortality after allogeneic transplantation	one year

Trial Locations

Locations (28)

Medizinische Univ.-Klinik Graz; 🇦🇹 Graz, Austria

Klin. Abt. für Onkologie, AKH Wien; 🇦🇹 Vienna, Austria

Staedtisches Klinikum; 🇩🇪 Augsburg, Germany

Dept. of Hematology/Oncology, Charité Berlin; 🇩🇪 Berlin, Germany

Charité University Medicine; 🇩🇪 Berlin, Germany

University Hospital; 🇩🇪 Regensburg, Germany

Krankenhaus Nordwest; 🇩🇪 Frankfurt, Germany

Freiburg University Hospital; 🇩🇪 Freiburg, Germany

Georg August University Hospital; 🇩🇪 Gottingen, Germany

Ernst-Moritz Arndt University Hospital; 🇩🇪 Greifswald, Germany

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