Last updated: 03/07/2025 08:40:52
Qualitative Interviews to Understand the Real World Participant Experience with BLENREP (Belantamab mafodotin)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Qualitative Interviews to Understand the Patient Experience in Participants Who Have Relapsed or Refractory Multiple Myeloma and Have Been Treated with BLENREP TM in the US
Trial description: This study aims to understand the participant experience of BLENREP treatment through open-ended questioning, and to explore the content validity of the Ocular Surface Disease Index (OSDI©) in Relapsed or refractory multiple myeloma (RRMM) population. BLENREP is a registered trademark of GlaxoSmithKline group of companies. OSDI is created by Allergan, Inc.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants reporting specific perceived risks/benefits of treatment with BLENREP
Timeframe: Up to 9 months
Number of participants reporting specific disease-related symptoms while on BLENREP treatment
Timeframe: Up to 9 months
Number of participants reporting specific experiences of treatment-related Adverse events (AEs), including ocular AEs (those affecting the eyes and/or vision)
Timeframe: Up to 9 months
Number of participants reporting specific impacts of disease-related symptoms on their health-related quality of life (HRQoL)
Timeframe: Up to 9 months
Number of participants reporting specific impacts of AEs on their HRQoL
Timeframe: Up to 9 months
Participants’ qualitative evaluations of their understanding of, and the conceptual relevance of, the OSDI while receiving BLENREP treatment
Timeframe: Up to 9 months
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
14
Primary completion date:
2022-23-11
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Multiple Myeloma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2022 to November 2022
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Male or female participants, aged greater than or equal to (>=)18 years.
- Has a diagnosis of RRMM.
- Currently participating in a BLENREP clinical trial.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female participants, aged greater than or equal to (>=)18 years.
- Has a diagnosis of RRMM.
- Currently treated with BLENREP. a) Participants started receiving BLENREP at least three months prior to recruitment (inclusive of any periods of dose delays or modifications); OR
- Participants previously treated with BLENREP and have discontinued their treatment within the past twelve months. a) Participants who have received BLENREP for at least three months prior to discontinuation (inclusive of any periods of dose delays or modifications).
- Participants willing and able to provide informed consent to participate in a 90-minute interview (or two 45-minute interviews, if required).
Exclusion criteria:
- Currently participating in a BLENREP clinical trial.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2022-23-11
Actual study completion date
2022-23-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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