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

Study Overview
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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.

Official Title
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Multizentrische Therapiestudie Des Multiplen Myeloms DSMM V Therapieoptimierungs-Studie Der Deutschen Studiengruppe Multiples Myelom für Patienten Bis 60 Jahre im Stadium II/III

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Biological: allogeneic stem cell transplant


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard risk IFN<br>Administration of interferon alpha as a maintenance treatment following autologous stem cell transplantation | |
| No Intervention: Standard risk PEGIFN<br>Maintenance treatment with pegylated interferon following autologous stem cell transplantation | |
| Experimental: High risk allo<br>Allogeneic stem cell transplantation from an HLA identical related or unrelated donor | Biological: allogeneic stem cell transplant<br> <br> |
| No Intervention: High risk auto<br>Second cycle of high-dose melphalan in subjects without an HLA-identical donor | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate after high-dose therapy |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate and treatment-related mortality after allogeneic transplantation |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary treatment, allogeneic stem-cell transplantation, high-dose therapy, cytogenetics