Clinical trial NCT05986682: Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
Official title: Real-World Analysis of Belantamab Mafodotin Care Patterns in Patients With Relapsed and/or Refractory Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Relapsed
Refractory
Ophthalmology
Keratopathy
Distress
National Comprehensive Cancer Network (NCCN) Distress Thermometer
Retrospective
Patient Reported Outcomes
Belantamab Mafodotin
Blenrep
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2023-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


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

Primary outcomes:
measure: Treatment Characteristics: Duration of Treatment With BLENREP
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Treatment Characteristics: Discontinuation of BLENREP Treatment
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Treatment Characteristics: Dosing Patterns - Number of Cycles of Treatment With BLENREP Therapy
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Treatment Characteristics: Dosing Patterns - Delays in Treatment With BLENREP Therapy
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Treatment Characteristics: Dosing Patterns - Dose Reductions During Treatment With BLENREP Therapy
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Clinical Outcomes: Best Overall Response
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Clinical Outcomes: Time To Response
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Clinical Outcomes: Time To Best Response
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Clinical Outcomes: Duration of Response
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Clinical Outcomes: Progression-Free Survival (PFS)
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Clinical Outcomes: Overall Survival (OS)
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Secondary outcomes:
measure: Ophthalmology: Presence of Ocular Toxicity
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Ophthalmology: Number of Ocular Toxicity Events Per Participant
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Ophthalmology: Treatments for Ocular Toxicity
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Magnitude of Distress Using National Comprehensive Cancer Network Distress Thermometer (NCCN DT)
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Sources of Distress Using NCCN DT: Frequency of Reported Problems
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Sources of Distress Using NCCN DT: Top 5 Most Frequently Reported Problems
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
measure: Healthcare Resource Utilization (HCRU)
timeFrame: Between baseline and earliest of end of BLENREP treatment, death, lost to contact or end of study timeframe, up to 40 months.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas W LeBlanc, MD
role: PRINCIPAL_INVESTIGATOR
References: