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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

This trial does not accept healthy volunteers

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 population

Fifty consecutive patients, who were referred to UUH for a second ASCT after relapse in multiple myeloma following HDM and ASCT between 1 Nov 2011 and 30 Jun 2018 and who received conditioning with bortezomib-bendamustine-melphalan will be included in this study. As a control group, 25 consecutive patients who were treated with HDM prior to 1 Nov 2011 and 25 consecutive patients following 30 Jun 2018. The patients will be identified through the local European Society for Blood and Marrow Transplantation (EBMT) registry at UUH.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Bortezomib-bendamustine-melphalan

    Drug

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Bortezomib-bendamustine-melphalan1 intervention
Group B: high-dose melphalan0 interventions

Trial outcomes

Primary outcomes

1

Mean difference in time to next treatment (TNT) after ASCT1 and ASCT2 for each individual patient

Average time to next myeloma treatment within each individual patient making each patient as its' own control

Time frame
0.2-18 years

Secondary outcomes

1

Median time to next treatment after ASCT2

Time to start of next myeloma treatment after ASCT2

Time frame
0-18 years
2

Median progression free survival (PFS) after ASCT2

Time to progression or death after ASCT2

Time frame
0-18 years
3

Median overall survival after ASCT2

Survival until death from any cause

Time frame
0-18 years
4

Depth of best response after ASCT2

Best result after given treatment for myeloma

Time frame
0-24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uppsala University

Lead sponsor

Uppsala County Council, Sweden

Collaborator

Dalarna County Council, Sweden

Collaborator

Source ClinicalTrials.gov
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