This trial is active, not recruiting.

Condition multiple myeloma
Treatment allogeneic hsct
Phase phase 2
Sponsor Universitätsklinikum Hamburg-Eppendorf
Start date November 2002
End date October 2011
Trial size 50 participants
Trial identifier NCT00599495, EBMT MUDRIC-MM


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

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.
time frame: Follow-up until day +1095

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title 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
Principal investigator Nicolaus Kroeger, Prof. Dr.
Trial information was received from ClinicalTrials.gov and was last updated in October 2008.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.