RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA
Conditions
Brief summary
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021. The focus of the study will be on the estimation of the magnitude of the treatment effect as assessed by the overall response rate (ORR), duration of response (DOR), progression free survival (PFS), overall survival (OS), and the safety of single agent belantamab mafodotin in patients with RRMM. Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first).
Detailed description
The proposal of this study is to retrospectively analyze the experience with belantamab mafodotin monotherapy in patients with RRMM included in the compassionate use or in the expanded access program in Spain between November 2019 and June 2021. Subjects may receive treatment until progression. Myeloma disease status will be evaluated locally for response and progression per International Myeloma Working Group (IMWG) criteria from cycle 1 day 1 until confirmed progressive disease, death, unacceptable toxicity, or lost to follow-up (whichever occurs first). The study has the following objectives: Primary objective \- The primary objective of this study is to evaluate the efficacy of belantamab mafodotin in terms of overall response, and the different response categories when administered as a single agent in patients with RRMM. Secondary objectives: * Describe the safety and tolerability of single-agent belantamab mafodotin. * The overall incidence of ophthalmologic complications. * Estimate duration of response (DOR). * Estimate time to response (TTR). * Estimate time to next treatment (TTNT). * Estimate progression-free survival (PFS) and overall survival (OS). * Type of treatment administered after single-agent belantamab mafodotin and estimate PFS2.
Interventions
DRUGBelantamab mafodotin
At least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021.
Sponsors
GlaxoSmithKline
PETHEMA Foundation
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Reception of at least one dose of belantamab mafodotin as part of the compassionate use or the expanded access program in Spain between November 2019 and June 2021
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Throughout the study period. Approximately 3 years | The percentage of participants with the best overall confirmed response: partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR). per International Myeloma Working Group (IMWG) uniform response criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ocular events | Throughout the study period. Approximately 3 years | Number and percentage of ocular events |
| Duration of response (DOR) | Throughout the study period. Approximately 3 years | The time from first date of PR or better to date of disease progression or death due to any cause. |
| Time to response (TTR) | Throughout the study period. Approximately 3 years | The time from date of first dose of belantamab mafodotin to date of first occurrence of response. |
| Incidence of treatment-emergent adverse events (AEs) | Throughout the study period. Approximately 3 years | Number and percentage of treatment-emergent adverse events (AEs) |
| Progression free survival (PFS) | Throughout the study period. Approximately 3 years | The time from start of treatment until progression or death from any cause |
| Overall survival (OS) | Throughout the study period. Approximately 3 years | The time from start of treatment until death from any cause. |
| Second progression free survival (PFS2) | Throughout the study period. Approximately 3 years | The time from start of belantamab mafodotin to progression on next-line treatment, or death from any cause, whichever is earlier; otherwise censored at the last time known to be alive and without second objective disease progression. |
| Time to next treatment (TTNT). | Throughout the study period. Approximately 3 years | The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment. |
Countries
Spain
Contacts
Primary ContactCarmen López-Carrero
Backup ContactRoberto Maldonado
Outcome results
None listed