Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma
NCT ID: NCT06245629
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-11-24
2025-11-30
Brief Summary
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Detailed Description
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Study population Fifty consecutive patients, who were referred to Uppsala University Hospital (UUH) for a second ASCT after relapse in multiple myeloma following HDM and ASCT between 1 Nov 2011 and 30 Oct 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 Oct 2018. The patients will be identified through the local European Society for Blood and Marrow Transplantation (EBMT) registry at UUH.
UUH is the referral hospital for seven Swedish regions with a total population of 2 151 353 at Dec 31 2022, which constitutes roughly one fifth of the population of Sweden.
Data collection Study data will be collected through systematic analysis of medical records from UUH and all the hospitals referring patients to UUH and from the Swedish Cancer Registry. All severe adverse events (AEs) will be collected until day 100 after ASCT2 according to National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Primary endpoints
• Mean TNT after ASCT1 and ASCT2 for each individual patient (each patient as its own control), for BBM and HDM-treated patients
Secondary endpoints
* Median time to next treatment (TNT) after ASCT2
* Median progression free survival (PFS) after ASCT2
* Depth of best response (stable disease (SD), partial response (PR), very good partial response (VGPR), complete remission (CR), stringent complete remission (sCR)) after ASCT2
* Median Overall survival after ASCT2
* Treatment related mortality rate at ASCT2
* Mean duration of neutropenia (ANC \< 0,5) at ASCT2
* Mean time until engraftment
* Mean duration of hospitalization after stem cell infusion at ASCT2
* The frequency of all serious adverse events according to version 5.0 of National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) during hospitalization and until day +100 after ASCT2.
Prespecified subgroups will include depth of best response prior to ASCT2, any specific maintenance therapies following ASCT2, patients receiving Granulocyte Colony Stimulating Factor (G-CSF) following ASCT, and patients receiving daratumumab as a part of induction or maintenance therapy at ASCT2.
In addition, an exploratory subgroup analysis is planned for patients with high-risk cytogenetics including p53-aberrations and patients with early relapse after ASCT1 (less than 3 years), although missing data is expected to be high.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Bortezomib-bendamustine-melphalan
Myeloma patients receiving bortezomib-bendamustine-melphalan at autologous hematopoietic stem cell transplantation first relapse.
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.
high-dose melphalan
Myeloma patients receiving high-dose melphalan at autologous hematopoietic stem cell transplantation at first relapse.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Uppsala County Council, Sweden
OTHER_GOV
Dalarna County Council, Sweden
OTHER
Uppsala University
OTHER
Responsible Party
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Principal Investigators
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Honar Cherif, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Uppsala University
Locations
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Akademiska sjukhuset
Uppsala, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Kristina Carlson, MD, PhD
Role: primary
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2023-04134-01
Identifier Type: -
Identifier Source: org_study_id