Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma
ConditionMyeloma Multiple
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUppsala University
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Bortezomib-bendamustine-melphalan
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Uppsala University
Lead sponsor
Uppsala County Council, Sweden
Collaborator
Dalarna County Council, Sweden
Collaborator
Source ClinicalTrials.gov