Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 218855 | Other Grant/Funding Number | GlaxoSmithKline |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blenrep | Drug | Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ophthalmology: Presence of Ocular Toxicity | Number of participants with specific ocular events of interest during treatment with BLENREP | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Thomas W LeBlanc, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40348718 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
57 Duke patients were identified with RRMM who began treatment with Blenrep between Aug 5, 2020 and Nov 22, 2022. 25 patients were excluded (9 concurrently receiving other therapies, 8 being followed by a local oncologist or without Blenrep Risk Evaluation and Mitigation Strategies [REMS] documentation, 5 with <1 mo. of follow-up, and 3 receiving Blenrep as part of an expanded access pathway). Of the 32 remaining patients, 30 patients were randomly selected for chart abstraction.
This was a single-site, retrospective, observational study examining longitudinal care patterns for belantamab mafodotin among relapsed and/or refractory multiple myeloma (RRMM) patients seen at Duke Cancer Institute (DCI).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Multiple Myeloma/Blenrep Participants | Participants 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Multiple Myeloma/Blenrep Participants | Participants 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at Treatment Initiation (Baseline) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients were analyzed. | Posted | Median | Inter-Quartile Range | Months | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
Between baseline and earliest death, lost to contact or end of study timeframe, up to 40 months.
Ocular AEs were collected per participant, not per eye. Hematologic toxicity was collected if it was a reason for change to treatment. No other AEs were collected. Ocular toxicity was collected systematically through optometrist visits; measured per the Keratopathy Visual Acuity scale, using belantamab mafodotin REMS guidelines. Ocular symptoms were reported ad hoc by patients at individual clinic visits, as a non-systematic assessment. Serious AEs were not monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multiple Myeloma/Blenrep Participants | Participants 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Keratopathy | Eye disorders | MedDRA v. 25.1 | Systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas W. LeBlanc | Duke University School of Medicine | 919-668-2115 | thomas.leblanc@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 6, 2023 | May 20, 2024 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | 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). | 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). | 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. | 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. | 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. | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
Number of Ocular Toxicity Events (Corneal Event or Best-Corrected Visual Acuity Change) per patient, summarized by median (min, max). |
| 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. | 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. | 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. | 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. | 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. | 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 |
| years |
|
| Age, Continuous | Age at Multiple Myeloma Diagnosis | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Current Payer type | Count of Participants | Participants |
|
| Diagnosis Location | Count of Participants | Participants |
|
| Multiple Myeloma (MM) Diagnostic Characteristics | Participants may have more than one diagnostic characteristic of MM. | Count of Participants | Participants |
|
| MM Subtype - Immunoglobulin (Ig) | Subtype of MM by Immunoglobulin - as determined at Diagnosis | Count of Participants | Participants |
|
| MM Subtype - Involved Serum Free Light Chain | Subtype of MM by involved serum free light chain - as determined at Diagnosis | Count of Participants | Participants |
|
| R-ISS Score | The Revised International Staging System (R-ISS) is a prognostic staging system used to stratify patients with MM based on genetic risk as assessed by fluorescence in-situ hybridization (FISH) and routinely used lab values. The R-ISS system consists of stage I: serum beta2-microglobulin < 3.5 milligram per liter (mg/L), albumin >= 3.5 gram per deciliter (g/dL), standard-risk chromosomal abnormalities (CA) by FISH and normal lactate dehydrogenase level (LDH); stage II: neither R-ISS stage I nor stage III; and stage III: beta2-microglobulin >= 5.5mg/L and either high-risk CA by FISH or high LDH. | Count of Participants | Participants |
|
| High Risk Abnormalities at Diagnosis | High-Risk abnormalities identified by cytogenetic testing at diagnosis. International Myeloma Working Group (IMWG)- defined High Risk is the percentage of patients who had any of the following high risk traits: t(4;14), t(14;16), del(17p). | Count of Participants | Participants |
|
| Standard-Risk Abnormalities at Diagnosis | Standard-Risk abnormalities identified by cytogenetic testing at diagnosis | Count of Participants | Participants |
|
| Median Number of Lines of Therapy prior to Baseline | Median | Full Range | Lines of therapy |
|
| Number of Prior Lines of Therapy - categorical | Count of Participants | Participants |
|
| Types of Prior Therapy | Count of Participants | Participants |
|
| Type of Refractory MM | Represents the number of lines patients were refractory to - Double (2 lines), Triple (3), Quad (4) or Penta (5) | Count of Participants | Participants |
|
| History of Prior Malignancy | Count of Participants | Participants |
|
| Baseline ECOG | Eastern Cooperative Oncology Group (ECOG) Performance Status as graded by clinician using the following Grades: 0: Fully active, able to carry on all pre-disease performance without restriction. 1: Restricted in physically strenuous activity but ambulatory, able to carry out work of light nature. 2: Ambulatory, capable of self-care, unable to carry out work activities. Up and about more than 50% waking hours. 3: Capable of limited self-care, confined to bed/chair more than 50% waking hours. 4: Completely disabled. Cannot carry on any self-care. Totally confined to bed/chair. 5: Dead. | Count of Participants | Participants |
|
| Baseline Renal Impairment | Baseline Renal Impairment - Estimated Glomerular Filtration Rate (eGFR) | Count of Participants | Participants |
|
| Baseline Renal Impairment (as measured by Serum Creatinine levels) | Serum Creatinine levels are used here as a measure of renal function. For this study, renal insufficiency is defined as a baseline serum creatinine level of >= 2.0 mg/dL. | Count of Participants | Participants |
|
|
|
| Primary | Treatment Characteristics: Discontinuation of BLENREP Treatment | Number of participants who discontinued treatment with BLENREP by reason. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Posted | Median | Full Range | Cycles | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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). | Posted | Median | Full Range | Months | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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). | Posted | Median | Full Range | Months | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Analyzed only for the 20 patients who achieved PR or better | Posted | Median | Full Range | Months | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Posted | Median | 95% Confidence Interval | Months | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Secondary | Ophthalmology: Presence of Ocular Toxicity | Number of participants with specific ocular events of interest during treatment with BLENREP | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Secondary | 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). | Posted | Median | Full Range | Events | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Secondary | Ophthalmology: Treatments for Ocular Toxicity | Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Secondary | 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. | Posted | Median | Full Range | DT Score | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Scores | Scores |
|
|
|
| Secondary | 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. | Posted | Count of Units | Visits | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Visits | Visits |
|
|
|
| Secondary | 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. | Posted | Count of Units | Visits | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Visits | Visits |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| Post-Hoc | Ophthalmology: Number of Ocular Symptoms Reported | Study procedures included recording ocular symptoms reported by patients documented in the clinic notes. These were categorized into blurry vision, dry eyes, photophobia and other symptoms (including foreign-body sensation, "grittiness", "itch/scratchiness", irritation, and tearing). This Data table reports the total number of Ocular Symptoms reported by patients, along with counts and percentage by type of symptom. | The 30 patients in the study reported specific symptoms a total of 192 times at clinic visits. The analysis population is the 192 symptoms reported. | Posted | Count of Units | Ocular Symptoms | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Ocular Symptoms | Ocular Symptoms |
|
|
|
| Post-Hoc | Ophthalmology: Grade of Ocular Toxicities (Corneal Events) | Ocular toxicity as measured by corneal events per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS [Risk Evaluation and Mitigation Strategies] guidelines. Corneal examination changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: Cornea clear/No change from baseline. Grade 1: Mild superficial keratopathy with or without symptoms. Grade 2: Moderate superficial keratopathy. Grade 3: Severe superficial keratopathy. Moderate/Severe keratopathy could be with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity. Grade 4: Corneal epithelial defect (such as corneal ulcer). The Data table reports the total number of corneal events experienced, along with counts and percentage by grade of event. | The 30 patients in the study experienced ocular toxicity (corneal events) a total of 323 times as reported during clinic visits. The analysis population is the 323 events reported. | Posted | Count of Units | Corneal Events | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Corneal Events | Corneal Events |
|
|
|
| Post-Hoc | Ophthalmology: Time to Resolution of Clinically Meaningful Ocular Toxicities - Corneal Events | Clinically Meaningful Event is defined as an event that is grade >= 2 for which BLENREP administration is halted until the event resolves to grade <= 1. Time to resolution is calculated for events that resolved. Unresolved events are those that had not returned to grade <=1 at last contact due to either end of study or lost to ophthalmologic follow-up. There were 64 resolved events for Corneal Events that were analyzed | Posted | Median | Full Range | Weeks | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Resolved Events | Resolved Events |
|
|
|
| Post-Hoc | Ophthalmology: Grade of Ocular Toxicities [Changes to Best-Corrected Visual Acuity (BCVA)] | Ocular toxicity as measured by changes to BVCA as measured per the Keratopathy Visual Acuity scale, and graded using belantamab mafodotin REMS [Risk Evaluation and Mitigation Strategies] guidelines. BVCA changes from baseline are categorized as normal or grade 1, 2, 3, or 4 and are based on the worst overall finding. Normal: No decline from baseline on Snellen Visual Acuity. Grade 1: Decline from baseline of 1 line on Snellen Visual Acuity. Grade 2: Decline from baseline of 2 or 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 3: Decline from baseline of more than 3 lines on Snellen Visual Acuity, and not worse than 20/200. Grade 4: Snellen Visual Acuity worse than 20/200. The Data table reports the total number of BVCA changes experienced, along with counts and percentage by grade of change. | The 30 patients in the study experienced ocular toxicity (changes to BVCA) a total of 244 times as reported during clinic visits. The analysis population is the 244 BVCA changes reported. | Posted | Count of Units | BVCA Changes | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | BVCA Changes | BVCA Changes |
|
|
|
| Post-Hoc | Ophthalmology: Time to Resolution of Clinically Meaningful Ocular Toxicities - Best Corrected Visual Acuity | Clinically Meaningful Event is defined as an event that is grade >= 2 for which BLENREP administration is halted until the event resolves to grade <= 1. Time to resolution is calculated for events that resolved. Unresolved events are those that had not returned to grade <=1 at last contact due to either end of study or lost to ophthalmologic follow-up. There were 44 Resolved events for changes in Best Corrected Visual Acuity that were analyzed. | Posted | Median | Full Range | Weeks | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. | Resolved Events | Resolved Events |
|
|
|
| Post-Hoc | Hospice Care Given Prior to Death | The number and percentage of patients who were in Hospice Care prior to death. Analyzed for the 10 patients who died as of last follow-up Dec. 1st 2023. | Posted | Count of Participants | Participants | Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. |
|
|
|
| 10 |
| 30 |
| 0 |
| 0 |
| 29 |
| 30 |
|
| Corneal epithelium defect | Eye disorders | MedDRA v. 25.1 | Systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Visual acuity reduced | Eye disorders | MedDRA v. 25.1 | Systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Blurred vision | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Dry eye | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Photophobia | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Foreign body sensation in the eye | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Eye pruritus | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Eye pain | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Eye irritation | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Lacrimation increased | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Ocular discomfort | Eye disorders | MedDRA v. 25.1 | Non-systematic Assessment | Ocular adverse events were collected per participant, not per eye. |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v. 25.1 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA v. 25.1 | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | MedDRA v. 25.1 | Systematic Assessment |
|
| Abnormal LFT (liver function test) | Investigations | MedDRA v. 25.1 | Systematic Assessment |
|
Not provided
Not provided
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Discontinuation for Physician/Patient choice |
|
| Discontinuation for other reason |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Delay for Hematologic Toxicity |
|
| Delay for Physician/Patient Choice |
|
| Delay for any other reason |
|
| Title | Measurements |
|---|---|
|
| Dose Reduction for Other Reason |
|
| Title | Measurements |
|---|
|
| SD |
|
| PD |
|
| Title | Measurements |
|---|---|
|
| Received a new prescription - Eye drops/ointment |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Physical Problems |
|
| Other Problems |
|
| Title | Measurements |
|---|---|
|
| Worry |
|
| Getting Around |
|
| Title | Measurements |
|---|---|
|
| Treatment-Related Outpatient Visits |
|
| Emergency Department Visits |
|
| Palliative Care Outpatient Visit |
|
| Title | Measurements |
|---|---|
|
| Photophobia |
|
| Other |
|
| Title | Measurements |
|---|---|
|
| Grade 3 |
|
| Grade 4 |
|
| Title | Measurements |
|---|---|
|
| Grade 3 |
|
| Grade 4 |
|
| Title | Measurements |
|---|
|