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Completed

NCT Number: NCT00781170

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Plasmacytoma Stem Cell Transplantation Vascular Diseases

Age range

18 year–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

allogeneic hematopoietic SCT

Procedure

Primary outcomes

  1. 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

  1. Evaluation of engraftment of leucocytes and platelets

  2. Evaluation of incidence of acute and chronic GvHD

  3. Evaluation of infectious complications

  4. Evaluation of the effects of DLI in case of no CR

  5. Evaluation of disease-free and overall survival

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study 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

Important dates

Study start
2000
First posted
Oct 28, 2008
Registry last updated
May 28, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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