The present study is a multicenter, prospective phase II-study to evaluate the chronic GvHD and progression-free survival at 2 years after after allogeneic stem cell transplantation for patients with multiple myeloma.
The present study is a multicenter, prospective Phase II-study to evaluate the incidence of acute and chronic graft-versus-host disease at 2-years, the 2-year risk of non-relapse mortality, the 2-year progressive-free, and overall survival in patients with multiple myeloma who received a toxicity-reduced conditioning regimen combined of thiotepa and busulfan followed by allogeneic stem cell transplantation from matched or mismatched, related/unrelated and haploidentical donor, and cyclophosphamide as post-transplant GvHD prophylaxis in comparision to a historical group. In this study will further determine toxicity and safety of cyclophosphamide as GvHD prophylaxis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
University Medical Center Hamburg-Eppendorf
Hamburg, Hamburg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Germany
Chronic GvHD
Chronic GvHD at 2 years after allogeneic SCT
Time frame: 2 years
Progression-free survival
Progression-free survival at 2 years after allogeneic SCT
Time frame: 2 years
Non-relapsed mortality
Non-relapsed mortality at 2 years after allogeneic SCT
Time frame: 2 years
Acute GvHD
Incidence of acute GvHD on Day +100 after allogeneic SCT
Time frame: Day +100 after allogeneic SCT
Chronic GvHD
Incidence of chronic GvHD at 1 and 2 years after allogeneic SCT
Time frame: 1 and 2 years after allogeneic SCT
Toxicity of cyclophosphamide
Toxicity scored according to NCI CTCAE, Version 4.0
Time frame: till 2 years
Remission rate
Complete remission rate (including sCR and MRD negativity)
Time frame: till 2 years
Overall Survival
Overall survival at 2 years
Time frame: 2 years
Progression-free Survival
Progression-free survival at 2 years
Time frame: 2 years
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