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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


Phase 2
18 Years
66 Years
Not Enrolling
Both
Multiple Myeloma, Stem Cell Transplantation

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome 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.

Safety Issue:

Yes

Principal Investigator

Nicolaus Kroeger, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Center Hamburg-Eppendorf, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Auto/Allo Plasmozytom

NCT ID:

NCT00781170

Start Date:

May 2000

Completion Date:

Related Keywords:

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

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