Myeloma MultipleNCT06245629
Bortezomib-bendamustine-melphalan vs Melphalan for Multiple Myeloma
An observational study of Myeloma Multiple, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma Multiple
- What is being tested?
- Bortezomib-bendamustine-melphalan
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 24 Nov 2024to 30 Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Akademiska sjukhuset
Uppsala
Kristina Carlson, MD, PhD
Thomas Silfverberg, MD
About this study
Official title: Bortezomib-bendamustine-melphalan vs High-dose Melphalan in Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma - a Single Center Retrospective Cohort Study
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.
Read the detailed description
Study design This is a retrospective single center cohort study comparing the new conditioning regimen bortezomib-bendamustine-melphalan to standard high-dose melphalan. The data sources will be electronic medical records and prospectively collected data from the Swedish Cancer Registry. The comparison will be analyzed in two parts. First, each patient will be its own control, comparing time to next treatment (TNT) for the first ASCT (always HDM, referred to as ASCT1) and second ASCT (BBM or HDM, referred to as ASCT2), and compare the mean difference between the two cohorts. Secondly, the difference in efficacy and severe adverse events between BBM and HDM at ASCT2 will be compared.
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
- Myeloma Multiple
- Being tested
- Bortezomib-bendamustine-melphalan
- Keywords
- Autologous hematopoietic stem cell transplantation, Melphalan, Bendamustine, Bortezomib
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bortezomib-bendamustine-melphalanDrug
Also called High-dose 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 group | Role | What they receive |
|---|---|---|
| Bortezomib-bendamustine-melphalan | Myeloma patients receiving bortezomib-bendamustine-melphalan at autologous hematopoietic stem cell transplantation first relapse. Receives: Drug: Bortezomib-bendamustine-melphalan | |
| high-dose melphalan | Myeloma patients receiving high-dose melphalan at autologous hematopoietic stem cell transplantation at first relapse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0.2-18 years
Secondary outcomes (9)
Median time to next treatment after ASCT2
Time to start of next myeloma treatment after ASCT2
Measured: 0-18 years
Median progression free survival (PFS) after ASCT2
Time to progression or death after ASCT2
Measured: 0-18 years
Median overall survival after ASCT2
Survival until death from any cause
Measured: 0-18 years
Depth of best response after ASCT2
Best result after given treatment for myeloma
Measured: 0-24 months
Treatment related mortality
Death due to any transplantation-related cause other than disease progression.
Measured: 0-12 months
Mean duration of neutropenia at ASCT2
Absolute neutrophil count (ANC) <0.5 x10^9
Measured: 7-50 days
Mean time until engraftment at ASCT2
Days from ASCT until ANC of 0.5 x 109/L or higher and total platelet count of 20 x 109/L and rising, without transfusion of thrombocytes.
Measured: 5-50 days
Mean duration of hospitalization at ASCT2
Days from ASCT until discharge
Measured: 7-50 days
Frequency of severe adverse events at ASCT2
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.
Measured: 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start24 Nov 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloma MultipleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala County Council, Sweden, Dalarna County Council, Sweden
- Responsible party
- Sponsor
- Investigators
- Honar Cherif, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245629
- Sponsor's protocol ID
- 2023-04134-01
- Other IDs
- 2023
- Status last verified
- Nov 2024
- First submitted
- 26 Sep 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, (text, tables, figures and appendices), will be available together with the study protocol after de-identification beginning 9 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal. To gain access, data requestors will need to sign a data access agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bortezomib-bendamustine-melphalan vs High-dose Melphalan in Autologous Hematopoietic Stem Cell Transplantation for Relapsed Multiple Myeloma - a Single Center Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06245629
- Acronym / sponsor ID
- 2023-04134-01
- Conditions
- Myeloma Multiple
- Keywords
- Autologous hematopoietic stem cell transplantation, Melphalan, Bendamustine, Bortezomib
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala County Council, Sweden, Dalarna County Council, Sweden
- Study start
- 24 Nov 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design This is a retrospective single center cohort study comparing the new conditioning regimen bortezomib-bendamustine-melphalan to standard high-dose melphalan. The data sources will be electronic medical records and prospectively collected data from the Swedish Cancer Registry. The comparison will be analyzed in two parts. First, each patient will be its own control, comparing time to next treatment (TNT) for the first ASCT (always HDM, referred to as ASCT1) and second ASCT (BBM or HDM, referred to as ASCT2), and compare the mean difference between the two cohorts. Secondly, the difference in efficacy and severe adverse events between BBM and HDM at ASCT2 will be compared.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bortezomib-bendamustine-melphalan | – | Drug: Bortezomib-bendamustine-melphalanMyeloma patients receiving bortezomib-bendamustine-melphalan at autologous hematopoietic stem cell transplantation first relapse. |
| high-dose melphalan | – | –Myeloma patients receiving high-dose melphalan at autologous hematopoietic stem cell transplantation at first relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bortezomib-bendamustine-melphalanAlso: High-dose melphalanThe 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. | Drug | Bortezomib-bendamustine-melphalan |
Primary outcome
Mean difference in time to next treatment (TNT) after ASCT1 and ASCT2 for each individual patient
Time frame: 0.2-18 years
Average time to next myeloma treatment within each individual patient making each patient as its' own control
9 secondary outcomes
Median time to next treatment after ASCT2
Time frame: 0-18 years
Median progression free survival (PFS) after ASCT2
Time frame: 0-18 years
Median overall survival after ASCT2
Time frame: 0-18 years
Depth of best response after ASCT2
Time frame: 0-24 months
Treatment related mortality
Time frame: 0-12 months
Mean duration of neutropenia at ASCT2
Time frame: 7-50 days
Mean time until engraftment at ASCT2
Time frame: 5-50 days
Mean duration of hospitalization at ASCT2
Time frame: 7-50 days
Frequency of severe adverse events at ASCT2
Time frame: 100 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, (text, tables, figures and appendices), will be available together with the study protocol after de-identification beginning 9 months and ending 5 years following article publication to researchers who provide a methodologically sound proposal. To gain access, data requestors will need to sign a data access agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Honar Cherif, MD, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloma Multiple, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Silfverberg, MD (+4623492000, thomas.silfverberg@regiondalarna.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean difference in time to next treatment (TNT) after ASCT1 and ASCT2 for each individual patient (time frame: 0.2-18 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.