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CompletedNCT00781170Updated May 28, 2009

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

A Phase 2 interventional study of allogeneic hematopoietic SCT in Multiple Myeloma and Stem Cell Transplantation, sponsored by Universitätsklinikum Hamburg-Eppendorf. Completed. Open to participants aged 18 Years to 66 Years. Per ClinicalTrials.gov, last updated 2009-05-28.

Sponsored by Universitätsklinikum Hamburg-Eppendorf · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 66 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Myeloma
  • Stem Cell Transplantation

Keywords

  • Multiple Myeloma
  • Plasmocytoma
  • Stem Cell Transplantation
03

In context

Multiple Myeloma

3,712 studies on the registry are indexed under Multiple Myeloma; 752 are open to participants now.

This study's planned enrollment of 20 is below the median of 41 across 2,965 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 415 studies on the registry; 85 are open to participants now.

Browse Universitätsklinikum Hamburg-Eppendorf studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 66 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Interventions

  • Procedureallogeneic hematopoietic SCT
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Kroger N, Badbaran A, Zabelina T, Ayuk F, Wolschke C, Alchalby H, Klyuchnikov E, Atanackovic D, Schilling G, Hansen T, Schwarz S, Heinzelmann M, Zeschke S, Bacher U, Stubig T, Fehse B, Zander AR. Impact of high-risk cytogenetics and achievement of molecular remission on long-term freedom from disease after autologous-allogeneic tandem transplantation in patients with multiple myeloma. Biol Blood Marrow Transplant. 2013 Mar;19(3):398-404. doi: 10.1016/j.bbmt.2012.10.008. Epub 2012 Oct 16. PubMed 23078786 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00781170
Lead sponsor
Universitätsklinikum Hamburg-Eppendorf
First posted
Oct 28, 2008
Start date
May 2000
Last update
May 28, 2009

Study contacts

Nicolaus Kroeger, Prof. Dr.
principal investigator · University Medical Center Hamburg-Eppendorf, Germany

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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