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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05986682

Enrollment

Registered

2023-08-14

Start date

2023-09-18

Completion date

2023-11-07

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Relapsed, Refractory, Ophthalmology, Keratopathy, Distress, National Comprehensive Cancer Network (NCCN) Distress Thermometer, Retrospective, Patient Reported Outcomes, Belantamab Mafodotin, Blenrep

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.

Interventions

DRUGBlenrep

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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.
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.
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.
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.

Secondary

Measure	Time frame	Description
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.
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.

Countries

United States

Participant flow

Recruitment details

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).

Pre-assignment details

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.

Participants by arm

Arm	Count
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.	30
Total	30

Baseline characteristics

Characteristic	Multiple Myeloma/Blenrep Participants
Age, Continuous	68 years
Baseline ECOG 1	11 Participants
Baseline ECOG 2	3 Participants
Baseline ECOG 3	1 Participants
Baseline ECOG Unknown	15 Participants
Baseline Renal Impairment Mild	16 Participants
Baseline Renal Impairment Moderate	10 Participants
Baseline Renal Impairment Normal	2 Participants
Baseline Renal Impairment Severe	2 Participants
Baseline Renal Impairment (as measured by Serum Creatinine levels) Serum Creatinine < 2.0 mg/dL	27 Participants
Baseline Renal Impairment (as measured by Serum Creatinine levels) Serum Creatinine ≥ 2.0 mg/dL	3 Participants
Current Payer type Commercial Alone	6 Participants
Current Payer type Medicaid Alone	1 Participants
Current Payer type Medicare + Commercial	19 Participants
Current Payer type Medicare + Medicaid	1 Participants
Current Payer type Medicare + Military	3 Participants
Diagnosis Location At Duke	15 Participants
Diagnosis Location External Location	15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
High Risk Abnormalities at Diagnosis 1q21 gain/amplification	12 Participants
High Risk Abnormalities at Diagnosis del(17p)/monosomy 17	4 Participants
High Risk Abnormalities at Diagnosis High Risk by IMWG	7 Participants
High Risk Abnormalities at Diagnosis t(14;16)	2 Participants
High Risk Abnormalities at Diagnosis t(14;20)	1 Participants
High Risk Abnormalities at Diagnosis t(4;14)	1 Participants
History of Prior Malignancy Bladder	1 Participants
History of Prior Malignancy Brain and Spinal Cord	1 Participants
History of Prior Malignancy Breast	1 Participants
History of Prior Malignancy Kidney	1 Participants
History of Prior Malignancy monoclonalgammopathy of unknown significance	2 Participants
History of Prior Malignancy Prostate	1 Participants
History of Prior Malignancy Skin Melanoma	1 Participants
History of Prior Malignancy Smoldering MM	5 Participants
History of Prior Malignancy Uterine	1 Participants
Median Number of Lines of Therapy prior to Baseline	4 Lines of therapy
MM Subtype - Immunoglobulin (Ig) IgA	9 Participants
MM Subtype - Immunoglobulin (Ig) IgD	0 Participants
MM Subtype - Immunoglobulin (Ig) IgE	0 Participants
MM Subtype - Immunoglobulin (Ig) IgG	16 Participants
MM Subtype - Immunoglobulin (Ig) IgM	0 Participants
MM Subtype - Immunoglobulin (Ig) Light Chain Only	0 Participants
MM Subtype - Immunoglobulin (Ig) Non-secretory	5 Participants
MM Subtype - Involved Serum Free Light Chain Kappa	18 Participants
MM Subtype - Involved Serum Free Light Chain Lambda	12 Participants
Multiple Myeloma (MM) Diagnostic Characteristics ≥ 100 serum free light chain (FLC) ratio	14 Participants
Multiple Myeloma (MM) Diagnostic Characteristics >= 10% Bone Marrow Plasma Cells	29 Participants
Multiple Myeloma (MM) Diagnostic Characteristics ≥ 1 Bone lesion (X-ray, CT, PET)	21 Participants
Multiple Myeloma (MM) Diagnostic Characteristics >1 focal lesion on MRI	5 Participants
Multiple Myeloma (MM) Diagnostic Characteristics >60% Bone Marrow plasma cells	17 Participants
Multiple Myeloma (MM) Diagnostic Characteristics Anemia	17 Participants
Multiple Myeloma (MM) Diagnostic Characteristics Bone Plasmacytoma	8 Participants
Multiple Myeloma (MM) Diagnostic Characteristics Extramedullary Plasmacytoma	1 Participants
Multiple Myeloma (MM) Diagnostic Characteristics Hypercalcemia	6 Participants
Multiple Myeloma (MM) Diagnostic Characteristics Plasmacytoma (Total)	9 Participants
Multiple Myeloma (MM) Diagnostic Characteristics Renal Insufficiency	5 Participants
Number of Prior Lines of Therapy - categorical < 4 Lines of Therapy	10 Participants
Number of Prior Lines of Therapy - categorical ≥ 4 Lines of Therapy	30 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	14 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants
Race (NIH/OMB) White	14 Participants
Region of Enrollment United States	30 Participants
R-ISS Score R-ISS I	2 Participants
R-ISS Score R-ISS II	5 Participants
R-ISS Score Unknown	23 Participants
Sex: Female, Male Female	16 Participants
Sex: Female, Male Male	14 Participants
Standard-Risk Abnormalities at Diagnosis Complex karyotype (when done) or karyotypic del(13)	14 Participants
Standard-Risk Abnormalities at Diagnosis MYC translocation	3 Participants
Standard-Risk Abnormalities at Diagnosis t(11;14)	3 Participants
Standard-Risk Abnormalities at Diagnosis t(6;14)	0 Participants
Standard-Risk Abnormalities at Diagnosis TP53 mutation	0 Participants
Standard-Risk Abnormalities at Diagnosis trisomies/tetrasomies	12 Participants
Type of Refractory MM Double	4 Participants
Type of Refractory MM Penta	13 Participants
Type of Refractory MM Quad	1 Participants
Type of Refractory MM Triple	12 Participants
Types of Prior Therapy Clinical Trials	6 Participants
Types of Prior Therapy Conventional Chemotherapy	20 Participants
Types of Prior Therapy Immunomodulatory Agents	30 Participants
Types of Prior Therapy Monoclonal Antibodies	29 Participants
Types of Prior Therapy Novel Agents	13 Participants
Types of Prior Therapy Other	2 Participants
Types of Prior Therapy Proteasome Inhibitors	30 Participants
Types of Prior Therapy Stem Cell Transplant	19 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	10 / 30
other Total, other adverse events	29 / 30
serious Total, serious adverse events	0 / 0

Outcome results

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.