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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00781170
Other study ID # Auto/Allo Plasmozytom
Secondary ID
Status Completed
Phase Phase 2
First received October 22, 2008
Last updated May 27, 2009
Start date May 2000

Study information

Verified date May 2009
Source Universitätsklinikum Hamburg-Eppendorf
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesGermany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 66 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
allogeneic hematopoietic SCT


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universitätsklinikum Hamburg-Eppendorf

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Yes
Secondary Evaluation of engraftment of leucocytes and platelets Yes
Secondary Evaluation of incidence of acute and chronic GvHD Yes
Secondary Evaluation of infectious complications Yes
Secondary Evaluation of the effects of DLI in case of no CR Yes
Secondary Evaluation of disease-free and overall survival Yes
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