TriangleNCT05986682 · REGISTRY CONDITION SEARCH
Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- Not reported
- Status at capture
- COMPLETED
- Registry last update
- 2025-02-03
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 (RRMM) seen in the Duke Cancer Institute (DCI) clinics.
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What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Treatment Characteristics: Duration of Treatment With BLENREP
Treatment Characteristics: Discontinuation of BLENREP Treatment
Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
Clinical Outcomes: Best Overall Response
Clinical Outcomes: Time To Response
Clinical Outcomes: Time To Best Response
Clinical Outcomes: Duration of Response
Clinical Outcomes: Progression-Free Survival (PFS)
Clinical Outcomes: Overall Survival (OS)
Ophthalmology: Presence of Ocular Toxicity
Ophthalmology: Number of Ocular Toxicity Events Per Participant
Ophthalmology: Treatments for Ocular Toxicity
Magnitude of Distress Using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)
Sources of Distress Using NCCN DT: Frequency of Reported Problems
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
Healthcare Resource Utilization (HCRU)
Ophthalmology: Number of Ocular Symptoms Reported
Ophthalmology: Grade of Ocular Toxicities (Corneal Events)
Ophthalmology: Time to Resolution of Clinically Meaningful Ocular Toxicities - Corneal Events
Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)]
Ophthalmology: Time to Resolution of Clinically Meaningful Ocular Toxicities - Best Corrected Visual Acuity
Hospice Care Given Prior to Death
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * 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. Exclusion Criteria: * 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
- maximum Age
- 89 Years
- minimum Age
- 18 Years
- sampling Method
- NON_PROBABILITY_SAMPLE
- sex
- ALL
- std Ages
- 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.
Treatment arms and interventions
- interventions
- description
- Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.
- name
- Blenrep
- type
- DRUG
Study design
- observational Model
- COHORT
- time Perspective
- RETROSPECTIVE
Enrollment
- count
- 30
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- 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.
- description
- Number of participants who discontinued treatment with BLENREP by reason.
- measure
- 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.
- description
- Treatment characteristics: Dosing patterns - Number of cycles of treatment with BLENREP therapy - From Treatment initiation to treatment discontinuation or last dose during study period.
- measure
- 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.
- description
- Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.
- measure
- 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.
- description
- Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.
- measure
- 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.
- description
- 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.
- measure
- 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.
- description
- The time from the start of BLENREP treatment to the date of first occurrence of response (partial response or better).
- measure
- 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.
- description
- The time from the start of BLENREP treatment to the date of the best response achieved (partial response or better).
- measure
- 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.
- description
- 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.
- measure
- 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.
- description
- 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.
- measure
- 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.
- description
- 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.
- measure
- 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.
- secondary Outcomes
- description
- Number of participants with specific ocular events of interest during treatment with BLENREP
- measure
- 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.
- description
- Number of Ocular Toxicity Events (Corneal Event or Best-Corrected Visual Acuity Change) per patient, summarized by median (min, max).
- measure
- 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.
- description
- Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.
- measure
- 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.
- description
- 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.
- measure
- 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.
- description
- 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.
- measure
- 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.
- description
- 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.
- measure
- 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.
- description
- 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.
- measure
- 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.
Full study description
- brief 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 (RRMM) seen in the Duke Cancer Institute (DCI) clinics.
Source references
- references
- citation
- 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.
- pmid
- 40348718
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice