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

NCT05986682 | Completed Results

• 2 other identifiers: Pro00110976218855
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

  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.

Secondary Outcomes (7)

• 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.

• 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.

• 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.

• 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.

• 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.

Interventions

Blenrep DRUG

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 40348718 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Thomas W. LeBlanc
• Organization: Duke University School of Medicine

thomas.leblanc@duke.edu

919-668-2115

Study Officials

• Thomas W LeBlanc, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 14, 2023
• Study Start: September 18, 2023
• Primary Completion: November 7, 2023
• Study Completion: November 7, 2023
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)