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.
Study Type
OBSERVATIONAL
Enrollment
30
Belantamab Mafodotin - blmf (BLENREP) given for the treatment of relapsed and/or refractory multiple myeloma.
Duke University Medical Center
Durham, North Carolina, United States
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.
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: Discontinuation of BLENREP Treatment
Number of participants who discontinued treatment with BLENREP by reason.
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
Treatment characteristics: Dosing patterns - Number of cycles of treatment with BLENREP therapy - From Treatment initiation to treatment discontinuation or last dose during study period.
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 - Delays in Treatment With BLENREP Therapy
Number of participants for whom BLENREP dosing was delayed during treatment as categorized by reason.
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 - Dose Reductions During Treatment With BLENREP Therapy
Number of participants for whom BLENREP dosing was dose reduced during treatment as categorized by reason.
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
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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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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: Presence of Ocular Toxicity
Number of participants with specific ocular events of interest during 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.
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).
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
Number of participants receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of 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.
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.
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
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.
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
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.
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)
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.
Time frame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.