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Clinical Trials in Sweden / NCT06245629
Recruiting Observational

Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma

NCT06245629 · tracked via the Priya Life Science Sweden tracker
Sponsor
Uppsala University
Phase
Observational
Started
2024-11-24
Last updated
2024-11-29

Condition(s) studied

Myeloma Multiple

Investigational drug(s) / intervention(s)

Bortezomib-bendamustine-melphalan →

Bortezomib-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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Mean difference in time to next treatment (TNT) after ASCT1 and ASCT2 for each individual patient — 0.2-18 years
    Average time to next myeloma treatment within each individual patient making each patient as its' own control

Trial sites (1)

FacilityCityRegionStatus
Akademiska sjukhuset Uppsala Sweden Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06245629 on ClinicalTrials.gov ↗ ← All trials in Sweden