RecruitingNCT06245629

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


Sponsor

Uppsala University

Enrollment

100 participants

Start Date

Nov 24, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria3

  • 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.

Interventions

DRUGBortezomib-bendamustine-melphalan

The aim of this retrospective cohort study is to evaluate the efficacy and safety of the conditioning regimen BBM compared to HDM in the setting of relapsed multiple myeloma.


Locations(1)

Akademiska sjukhuset

Uppsala, Sweden

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NCT06245629


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