Clinical trial · Observational
Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma
Bortezomib-bendamustine-melphalan vs High-dose Melphalan in Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma - a Single Center Retrospective Cohort Study
- 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)
This project will evaluate the efficacy and safety of the conditioning regimen bortezomib-bendamustine-melphalan (BBM) in combination with autologous hematopoietic stem cell transplantation (ASCT) in relapsed multiple myeloma given from 2011 to 2018 at Uppsala University Hospital. This approach will be retrospectively compared to high dose melphalan (HDM) in the same setting in the years prior to, and following the BBM-period. Data on efficacy and safety data will be collected through systematic analysis of electronic medical records and from the Swedish Cancer Registry.
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 |
|---|---|---|---|
| Myeloma Multiple | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib-bendamustine-melphalan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Bortezomib-bendamustine-melphalan
- description
- Myeloma patients receiving bortezomib-bendamustine-melphalan at autologous hematopoietic stem cell transplantation first relapse.
- interventionNames
- Drug: Bortezomib-bendamustine-melphalan
- label
- high-dose melphalan
- description
- Myeloma patients receiving high-dose melphalan at autologous hematopoietic stem cell transplantation at first relapse.
Primary outcomes (1)
- measure
- Mean difference in time to next treatment (TNT) after ASCT1 and ASCT2 for each individual patient
- timeFrame
- 0.2-18 years
- description
- Average time to next myeloma treatment within each individual patient making each patient as its' own control
Secondary outcomes (9)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of first relapse after previous ASCT for multiple myeloma according to the International Myeloma Working Group. * Treated with a second ASCT (ASCT2) as part of second line treatment at UUH. * Conditioning at ASCT2 with bortezomib-bendamustine-melphalan or high-dose melphalan only. Exclusion Criteria: * Double (tandem) ASCT in first or second line treatment * Allogenic haematopoietic stem cell transplantation as part of first or second line therapy * Failure to meet the minimal dataset, defined as: (date of ASCT1 and ASCT2, date of start of induction treatment for relapsed myeloma prior to ASCT2, medical records from hospitalization for ASCT2, at least one follow-up visit (unless early death before first follow-up visit), date of progression and first treatment of relapsed multiple myeloma after ASCT2.
References
Publications (0)
Data not yet available