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

Universitätsklinikum Hamburg-Eppendorf

Status and phase

Completed

Phase 2

Conditions

Stem Cell Transplantation

Multiple Myeloma

Treatments

Procedure: allogeneic hematopoietic SCT

Study type

Interventional

Funder types

Other

Identifiers

NCT00781170

Auto/Allo Plasmozytom

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 66 years old

Volunteers

No Healthy Volunteers

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