Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic hematopoietic SCT | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
Secondary outcomes (5)
- measure
- Evaluation of engraftment of leucocytes and platelets
- measure
- Evaluation of incidence of acute and chronic GvHD
- measure
- Evaluation of infectious complications
- measure
- Evaluation of the effects of DLI in case of no CR
- measure
- Evaluation of disease-free and overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 66 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKroger 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. PMID 23078786