Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma

An observational study of Multiple Myeloma, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to describe the real-world use of Belantamab Mafodotin - blmf (BLENREP) and associated patterns of care, including dosing and dose modification, eye care specialist visits, associated healthcare utilization, and clinical outcomes in patients with relapsed and/or refractory multiple myeloma… Read more about this study

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Multiple Myeloma
What is being tested?: Blenrep
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 18 Sep 2023to 7 Nov 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 89 years
All sexes
Adult, Older adult

Study population: The study will analyze clinical data from adult patients with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023.

Who may be able to join

Age > 18 years of age as of start of treatment with BLENREP
Patients with a corresponding diagnosis code consistent with multiple myeloma seen at Duke.
Patients with a record of starting treatment with BLENREP for RRMM between August 5, 2020 and November 22, 2022.
Patients having healthcare encounters at Duke Cancer Institute (DCI) for at least 1-month after start of Blenrep treatment.

Who cannot join

Patients who were included in any clinical trial for BLENREP including expanded access clinical trials
Age > 89 years of age as of start of index therapy

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

Conditions: Multiple Myeloma
Being tested: Blenrep
Keywords: Relapsed, Refractory, Ophthalmology, Keratopathy, Distress, National Comprehensive Cancer Network (NCCN) Distress Thermometer, Retrospective, Patient Reported Outcomes, Belantamab Mafodotin, Blenrep
Medical subject headings: Multiple Myeloma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BlenrepDrug
Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment Characteristics: Duration of Treatment With BLENREP
Duration of Treatment Duration calculated from first Blenrep dose to either treatment discontinuation (for subjects who discontinued treatment prior to study end date) or last dose (for subjects who were continuing treatment as of study end date). Descriptive statistics consisting of the median (with interquartile range) was used to summarize duration across participants.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Treatment Characteristics: Discontinuation of BLENREP Treatment
Number of participants who discontinued treatment with BLENREP by reason.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
Treatment characteristics: Dosing patterns - Number of cycles of treatment with BLENREP therapy - From Treatment initiation to treatment discontinuation or last dose during study period.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Clinical Outcomes: Best Overall Response
Response categorized using modified IMWG 2016 criteria. Urine testing was not routinely done; only serum M-protein levels were used when determining response. Complete Response(CR)= negative immunofixation on the serum + absence of any soft tissue plasmacytomas + <5% plasma cells in bone marrow aspirates. Very Good Partial Response(VGPR) = serum detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein. Partial Response(PR) = ≥50% reduction of serum M-protein. If the serum is unmeasurable, a > 50% decrease in the difference between involved and uninvolved FLC levels is required. Stable Disease (SD) = not meeting criteria for CR, VGPR, PR, or progressive disease. Progressive Disease (PD) = >25% increase from lowest response value in serum M-protein (the absolute increase must be >0.5 g/dL), or definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Clinical Outcomes: Time To Response
The time from the start of BLENREP treatment to the date of first occurrence of response (partial response or better).
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Clinical Outcomes: Time To Best Response
The time from the start of BLENREP treatment to the date of the best response achieved (partial response or better).
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Clinical Outcomes: Duration of Response
The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Clinical Outcomes: Progression-Free Survival (PFS)
The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Clinical Outcomes: Overall Survival (OS)
Summary report of patient status at the end of the study period. Duration of survival was calculated, however, median survival time for OS has not yet been reached, and therefore is not reported here.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.

Secondary outcomes (7)

Ophthalmology: Presence of Ocular Toxicity
Number of participants with specific ocular events of interest during treatment with BLENREP
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Ophthalmology: Number of Ocular Toxicity Events Per Participant
Number of Ocular Toxicity Events (Corneal Event or Best-Corrected Visual Acuity Change) per patient, summarized by median (min, max).
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Ophthalmology: Treatments for Ocular Toxicity
Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Magnitude of Distress Using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)
Distress is measured on a scale of 0-10 on the National Comprehensive Cancer Network Distress Thermometer (NCCN DT). A score of 0 represents no distress, and a score of 10 represents worst possible distress. Actionable distress is defined as a NCCN DT score of 4 or higher, and is aligned with the medical practice guidelines for management of distress in cancer patients.The median (min, max) distress score across patients is reported.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Sources of distress will be assessed using the NCCN DT Problem List by examining the percentage of visits where types of problems are reported. There are five categories of distress from which patients can report problems (practical, family, emotional, physical and other problems). The categories of problems are reported as a number and % of the total number of visits where problem lists are reported.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Sources of distress will be assessed using the NCCN DT Problem List by examining the percentage of visits where types of problems are reported. The problem list includes 39 possible problems from which patients can choose. The problems are reported as a number and % of the total number of visits where problem lists are reported.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Healthcare Resource Utilization (HCRU)
To the extent that they are available, HCRU [i.e., radiation therapy, transfusions (red blood cells or platelets), inpatient admissions, treatment-related outpatient visits, emergency department visits, palliative care outpatient visits] that occurred during BLENREP treatment will be summarized by the percentage and frequency distribution of patients with any occurrence of the respective outcome.
Measured: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 20237 Nov 2023

First posted14 Aug 2023
Study start18 Sep 2023
Primary completion7 Nov 2023
Study completion7 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
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: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05986682
Sponsor's protocol ID: Pro00110976
Other IDs: 218855
Status last verified: Jan 2025
First submitted: 24 Jul 2023
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Patel MN, Locke SC, Falvey C, Troy JD, Herring KW, Bolgioni-Smith A, Elcock C, Iadeluca L, Costa Chase C, Gasparetto C, Newman MS, LeBlanc TW. Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis. Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):e570-e579.e4. doi: 10.1016/j.clml.2025.04.008. Epub 2025 Apr 15.
PubMed 40348718

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
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RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
ClinicalTrials.gov ID: NCT05986682
Acronym / sponsor ID: Pro00110976
Conditions: Multiple Myeloma
Keywords: Relapsed, Refractory, Ophthalmology, Keratopathy, Distress, National Comprehensive Cancer Network (NCCN) Distress Thermometer, Retrospective, Patient Reported Outcomes
Study type: Observational
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: 18 Sep 2023 (actual)
Primary completion: 7 Nov 2023 (actual)
Study completion: 7 Nov 2023 (actual)
First posted: 14 Aug 2023 (actual)
Results: Posted 3 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Retrospective

Who may qualify

Ages: 18 to 89 years
Sex: All
Age groups: Adult, Older adult
Study population: The study will analyze clinical data from adult patients with relapsed and/or refractory multiple myeloma who were treated with Belantamab Mafodotin - blmf (BLENREP) in the DCI Oncology outpatient clinics between August 5, 2020 and November 7, 2023.

Key inclusion criteria (4 listed)

Age > 18 years of age as of start of treatment with BLENREP
Patients with a corresponding diagnosis code consistent with multiple myeloma seen at Duke.
Patients with a record of starting treatment with BLENREP for RRMM between August 5, 2020 and November 22, 2022.
Patients having healthcare encounters at Duke Cancer Institute (DCI) for at least 1-month after start of Blenrep treatment.

Key exclusion criteria (2 listed)

Patients who were included in any clinical trial for BLENREP including expanded access clinical trials
Age > 89 years of age as of start of index therapy

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
BlenrepBelantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.	Drug	–

Primary outcome

Treatment Characteristics: Duration of Treatment With BLENREP
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Duration of Treatment Duration calculated from first Blenrep dose to either treatment discontinuation (for subjects who discontinued treatment prior to study end date) or last dose (for subjects who were continuing treatment as of study end date). Descriptive statistics consisting of the median (with interquartile range) was used to summarize duration across participants.
Treatment Characteristics: Discontinuation of BLENREP Treatment
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Number of participants who discontinued treatment with BLENREP by reason.
Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Treatment characteristics: Dosing patterns - Number of cycles of treatment with BLENREP therapy - From Treatment initiation to treatment discontinuation or last dose during study period.
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.
Clinical Outcomes: Best Overall Response
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Response categorized using modified IMWG 2016 criteria. Urine testing was not routinely done; only serum M-protein levels were used when determining response. Complete Response(CR)= negative immunofixation on the serum + absence of any soft tissue plasmacytomas + <5% plasma cells in bone marrow aspirates. Very Good Partial Response(VGPR) = serum detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein. Partial Response(PR) = ≥50% reduction of serum M-protein. If the serum is unmeasurable, a > 50% decrease in the difference between involved and uninvolved FLC levels is required. Stable Disease (SD) = not meeting criteria for CR, VGPR, PR, or progressive disease. Progressive Disease (PD) = >25% increase from lowest response value in serum M-protein (the absolute increase must be >0.5 g/dL), or definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas.
Clinical Outcomes: Time To Response
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
The time from the start of BLENREP treatment to the date of first occurrence of response (partial response or better).
Clinical Outcomes: Time To Best Response
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
The time from the start of BLENREP treatment to the date of the best response achieved (partial response or better).
Clinical Outcomes: Duration of Response
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
The time from the first date of PR or better to the earliest of documented disease progression, end of BLENREP treatment, death, lost to followup or end of study timeframe.
Clinical Outcomes: Progression-Free Survival (PFS)
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
The time from the start of BLENREP treatment until the earliest of documented disease progression (according to IMWG response criteria or clinician assessment), end of BLENREP treatment, death, lost to followup or end of study timeframe.
Clinical Outcomes: Overall Survival (OS)
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Summary report of patient status at the end of the study period. Duration of survival was calculated, however, median survival time for OS has not yet been reached, and therefore is not reported here.

7 secondary outcomes

Ophthalmology: Presence of Ocular Toxicity
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Ophthalmology: Number of Ocular Toxicity Events Per Participant
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Ophthalmology: Treatments for Ocular Toxicity
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Magnitude of Distress Using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Healthcare Resource Utilization (HCRU)
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.

Results and safety

Results posted to the registry on 3 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Multiple Myeloma/Blenrep Participants	30	30

Primary outcome: Treatment Characteristics: Duration of Treatment With BLENREP

Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.. Median (Inter-Quartile Range). Unit: Months

Measure	Multiple Myeloma/Blenrep Participants n = 30
Value	9.3 (0.7 to 21.6)

Population analysed: All patients were analyzed.

Primary outcome: Treatment Characteristics: Discontinuation of BLENREP Treatment

Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.. Count of participants. Unit: Participants

Measure	Multiple Myeloma/Blenrep Participants n = 30
Discontinuations for any reason	26
Discontinuation for Disease Progression	22
Discontinuation for Corneal or other ocular toxicity	4
Discontinuation for Physician/Patient choice	3
Discontinuation for other reason	3

Primary outcome: Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy

Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.. Median (Full Range). Unit: Cycles

Measure	Multiple Myeloma/Blenrep Participants n = 30
Total # of cycles	6.5 (2 to 13)
# of cycles at 2.5 mg/kg^2	2 (1 to 11)
# of cycles at 1.9 mg/kg^2	3 (1 to 11)

Primary outcome: Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy

Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.. Count of participants. Unit: Participants

Measure	Multiple Myeloma/Blenrep Participants n = 30
Delay for any reason	27
Delay for Corneal AE	27
Delay for Other Ocular Toxicity	2
Delay for Hematologic Toxicity	3
Delay for Physician/Patient Choice	2
Delay for any other reason	10

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Multiple Myeloma/Blenrep Participants	0 of 0	29 of 30 (96.7%)	10 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40348718Patel MN, Locke SC, Falvey C, Troy JD, Herring KW, Bolgioni-Smith A, Elcock C, Iadeluca L, Costa Chase C, Gasparetto C, Newman MS, LeBlanc TW. Treatment Patterns, Efficacy, and Tolerability of Belantamab Mafodotin in Patients With Relapsed and/or Refractory Multiple Myeloma: A Real-World Analysis. Clin Lymphoma Myeloma Leuk. 2025 Aug;25(8):e570-e579.e4. doi: 10.1016/j.clml.2025.04.008. Epub 2025 Apr 15.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

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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. This study is not recruiting at the moment.

Thomas W LeBlanc, MD principal investigator

Duke 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 Multiple Myeloma, run by Duke University at 1 site in United States.

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 4 inclusion and 2 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: finished, as of the sponsor's last update on 3 Feb 2025. 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 United States. 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?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment Characteristics: Duration of Treatment With BLENREP (time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986682, which also lists 1 linked publication.

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 3 Feb 2025.