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

Universitätsklinikum Hamburg-Eppendorf

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Procedure: allogeneic HSCT

Study type

Interventional

Funder types

Other

Identifiers

NCT00599495

EBMT MUDRIC-MM

Details and patient eligibility

About

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.

Full description

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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