Multiple Myeloma Clinical Trial
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
Verified date | September 2022 |
Source | Universitätsklinikum Hamburg-Eppendorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Medical Center Hamburg-Eppendorf | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Kröger N, Shimoni A, Schilling G, Schwerdtfeger R, Bornhäuser 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 multi — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Engraftment, chimerism, toxicity, non-relapse mortality | Follow-up until day +1095 | ||
Secondary | 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 |
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