Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.

Detailed Description
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The purpose of this study is to determine whether a reduced intensity conditioning regimen followed by allogeneic stem cell transplantation from unrelated donors is a feasible and effective treatment for patients with multiple myeloma who failed a previous autologous stem cell transplantation.

Official Title
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Allogeneic Stem Cell Transplantation From Unrelated Donors After Dose-reduced Intensity Conditioning Regimen for Patients With Multiple Myeloma and Relapse After Autologous Stem Cell Transplantation: A Phase II-study

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Procedure: allogeneic HSCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Multiple Myeloma stage II or III acc. to Salmon and Durie (chemosensitive or refractory) and relapse or progression after high dose chemotherapy with autologous stem cell support Age 18-60 years ECOG-performance status 0-1 Availability of a HLA-compatible unrelated donor (HLA-A, -B, -DRB1, -DQB1) Exclusion Criteria: Serious concomitant medical disease that would limit life span or ability to tolerate chemotherapy Severe cardiac failure (ejection fraction < 40%) Severe impairment of renal function (Creatinine clearance < 50ml/min) Severe impairment of liver function (bilirubine > 2 fold of upper limits of normal) Pregnant or lactating women Other major organ or system dysfunctions(GI, neurological, psychiatric dysfunctions that would impair tolerance of chemotherapy or prolonged haematological recovery) Positivity for HIV

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: allogeneic HSCT|dose-reduced conditioning regimen|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engraftment, chimerism, toxicity, non-relapse mortality |  | Follow-up until day +1095 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of response/GvHD/ infectious complications/ disease-free survival, Prognostic impact of cytogenetic, Evaluation of incidence and prognostic impact of molecular remission in patients with clinically complete remission. |  | Follow-up until day +1095 | 

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