Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT05986682
- Lead Sponsor
- Duke University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Outcomes: Best Overall Response 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 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 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 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.
Treatment Characteristics: Duration of 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. 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 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 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 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.
Clinical Outcomes: Progression-Free Survival (PFS) 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.
Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy 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: Overall Survival (OS) 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.
- Secondary Outcome Measures
Name Time Method Sources of Distress Using NCCN DT: Frequency of Reported Problems 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 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.
Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems 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 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.
Healthcare Resource Utilization (HCRU) Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. 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.
Ophthalmology: Presence of Ocular Toxicity 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 with specific ocular events of interest during treatment with BLENREP
Ophthalmology: Number of Ocular Toxicity Events Per Participant 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).
Ophthalmology: Treatments for Ocular Toxicity 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 receiving treatment for ocular toxicity during BLENREP therapy, as categorized by type of treatment.
Magnitude of Distress Using National Comprehensive Cancer Network Distress Thermometer (NCCN DT) Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months. 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.
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States