Clinical trial · Interventional
Stem Cell Translpantation in Multiple Myeloma
A Phase-II Study Comparing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Following Autologous Transplantation to Autologous Transplantation Alone in Multiple Myeloma
- 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)
The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.
Conditions
Conditions (1)
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 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLA Matched allogeneic transplant | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- auto/RICallo treatment arm
- description
- Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108)
- interventionNames
- Procedure: HLA Matched allogeneic transplant
- type
- ACTIVE_COMPARATOR
- label
- auto arm
- description
- patients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104)
- interventionNames
- Procedure: HLA Matched allogeneic transplant
Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed Stage-II and III multiple myeloma (According to Durie and Salmon classification) * Age under 70 years * Life expectancy over 3 months * Patients must be able to give informed consent Exclusion Criteria: * Serious concomitant medical disease which would limit life span or the ability to tolerate chemotherapy * Severe cardiac failure (ejection fraction \<40%) * Impairment of renal function at diagnosis is not per se reason for exclusion but patients with severe impaired renal function (GFR \<50 ml/min) after initial VAD (or VAD like) induction treatment are excluded * Severe impairment of liver function (bilirubin \>2 times upper limit of normal) * Pregnant or lactating women * Other major organ system dysfunction (GI, neurological, psychiatric dysfunction) that impairs tolerance of therapy or prolong hematological recovery
References
Publications (0)
Data not yet available