Clinical trial NCT00599495: Matched Unrelated Donor Stem Cell Transplantation (MUD-SCT) After Dose-reduced Conditioning for Patients With Multiple Myeloma and Relapse After Autologous SCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Hematopoietic Stem Cell Transplantation
Multiple Myeloma
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Engraftment, chimerism, toxicity, non-relapse mortality
timeFrame: Follow-up until day +1095
Secondary outcomes:
measure: 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.
timeFrame: Follow-up until day +1095
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Nicolaus Kroeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroger N, Shimoni A, Schilling G, Schwerdtfeger R, Bornhauser M, Nagler A, Zander AR, Heinzelmann M, Brand R, Gahrton G, Morris C, Niederwieser D, de Witte T. Unrelated stem cell transplantation after reduced intensity conditioning for patients with multiple myeloma relapsing after autologous transplantation. Br J Haematol. 2010 Jan;148(2):323-31. doi: 10.1111/j.1365-2141.2009.07984.x. Epub 2009 Nov 12.