Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma

Study Overview
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Brief Summary
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To evaluate the feasibility and efficacy of a autologous stem cell transplantation followed by a Melphalan/ Fludarabine based dose-reduced allograft from HLA-identical and HLA-compatible unrelated donor in patients with Multiple Myeloma. In those with non complete remission DLI and/ or new agents such as Bortezomib, Thalidomid or Lenalidomide can be used to upgrade remission.

Official Title
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Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III

Conditions
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Multiple Myeloma, Stem Cell Transplantation

Intervention / Treatment
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* Procedure: allogeneic hematopoietic SCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple Myeloma Stadium II / III acc. to Salmon and Durie signed informed consent adequate organ function prior autologous respectively allogeneic SCT availability of HLA-identical related or unrelated donor availability of at least 2 x 10^6 CD34+ cells per kg BW of recipient for the autologous SCT and at least 3 x 10^6 CD34+ cells for allogeneic SCT for MRD-SCT: 18-66 years; for MUD-SCT: 18-55 years at age <55 years existence of risk factors that make an myeloablative allogeneic transplantation to risky consent of donor to give DLI Exclusion Criteria: severe heart insufficiency cardiovascular diseases or severe concomitant diseases active infections that need antibiotic therapy positive for HIV or hepatitis malign secondary disease limited liver function with total bilirubin > 1.5 ULN increased transaminase > 3 ULN increased serum creatinine > 2 mg/dl pregnant or lactating women known hypersensitivity to Fludarabine or Melphalan participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 66 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: allogeneic hematopoietic SCT|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of engraftment of leucocytes and platelets |  |  | 
| Evaluation of incidence of acute and chronic GvHD |  |  | 
| Evaluation of infectious complications |  |  | 
| Evaluation of the effects of DLI in case of no CR |  |  | 
| Evaluation of disease-free and overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation