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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781170

Enrollment

Registered

2008-10-28

Start date

2000-05-31

Completion date

Unknown

Last updated

2009-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Stem Cell Transplantation

Keywords

Multiple Myeloma, Plasmocytoma, Stem Cell Transplantation

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.

Interventions

PROCEDUREallogeneic hematopoietic SCT

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 66 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026