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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781170
• Other study ID #: Auto/Allo Plasmozytom
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Stem Cell Transplantation

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