Dose-Reduced Allogeneic Stem Cell Transplantation After Autologous High-Dose Chemotherapy in Patients With Multiple Myeloma

Phase 2

Completed

• Conditions: Multiple Myeloma; Stem Cell Transplantation

• Registration Number: NCT00781170
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2008-10-22
• Study First Submitted QC: 2008-10-27
• Study First Posted: 2008-10-28
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-27
• Last Update Posted: 2009-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Evaluation of engraftment of leucocytes and platelets
Evaluation of the effects of DLI in case of no CR
Evaluation of disease-free and overall survival
Evaluation of incidence of acute and chronic GvHD
Evaluation of infectious complications