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

Universitätsklinikum Hamburg-Eppendorf1 site in 1 country50 target enrollmentNovember 2002

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

November 2002

End Date

December 2009

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Engraftment, chimerism, toxicity, non-relapse mortality

Time Frame: Follow-up until day +1095

Secondary Outcomes

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)