Clinical trial NCT00781170: Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma
Official title: Dose-Reduced Allogeneic Stem Cell Transplantation as Induction of a Graft-Versus-Myeloma-Effect After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma Stage II/III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Stem Cell Transplantation
Keywords: Multiple Myeloma
Plasmocytoma
Stem Cell Transplantation
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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:

* severe heart insufficiency
* cardiovascular diseases or severe concomitant diseases
* active infections that need antibiotic therapy
* positive for HIV or hepatitis
* malign secondary disease
* limited liver function with total bilirubin \> 1.5 ULN
* increased transaminase \> 3 ULN
* increased serum creatinine \> 2 mg/dl
* pregnant or lactating women
* known hypersensitivity to Fludarabine or Melphalan
* participation in another trial

Primary outcomes:
measure: Safety and efficacy of a conditioning regimen with Fludarabine, Melphalan and ATG prior allogeneic SCT after high dose chemotheraoie and autologous SCT. Evaluation of underlying disease and donor-recipient-chimerism.
Secondary outcomes:
measure: Evaluation of engraftment of leucocytes and platelets
measure: Evaluation of incidence of acute and chronic GvHD
measure: Evaluation of infectious complications
measure: Evaluation of the effects of DLI in case of no CR
measure: Evaluation of disease-free and overall survival
Other outcomes:
Locations:
Study officials:
affiliation: University Medical Center Hamburg-Eppendorf, Germany
name: Nicolaus Kroeger, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroger N, Badbaran A, Zabelina T, Ayuk F, Wolschke C, Alchalby H, Klyuchnikov E, Atanackovic D, Schilling G, Hansen T, Schwarz S, Heinzelmann M, Zeschke S, Bacher U, Stubig T, Fehse B, Zander AR. Impact of high-risk cytogenetics and achievement of molecular remission on long-term freedom from disease after autologous-allogeneic tandem transplantation in patients with multiple myeloma. Biol Blood Marrow Transplant. 2013 Mar;19(3):398-404. doi: 10.1016/j.bbmt.2012.10.008. Epub 2012 Oct 16.