An observational study in RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA, sponsored by PETHEMA Foundation. Status unknown at 62 sites in Spain. Per ClinicalTrials.gov, last updated 2022-08-05.
Sponsored by PETHEMA Foundation · Observational
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).
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
Secondary objectives:
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's planned enrollment of 170 is above the median of 140 across 468 observational studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →PETHEMA Foundation is the lead sponsor of 104 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Every patient receiving 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 will be included in the study.
Inclusion Criteria:
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.
Overall response rate (ORR)
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.
Time frame: Throughout the study period. Approximately 3 years
Incidence of treatment-emergent adverse events (AEs)
Number and percentage of treatment-emergent adverse events (AEs)
Time frame: Throughout the study period. Approximately 3 years
Incidence of ocular events
Number and percentage of ocular events
Time frame: Throughout the study period. Approximately 3 years
Duration of response (DOR)
The time from first date of PR or better to date of disease progression or death due to any cause.
Time frame: Throughout the study period. Approximately 3 years
Time to response (TTR)
The time from date of first dose of belantamab mafodotin to date of first occurrence of response.
Time frame: Throughout the study period. Approximately 3 years
Time to next treatment (TTNT).
The time from first dose of belantamab mafodotin to first day when subject receives another myeloma treatment.
Time frame: Throughout the study period. Approximately 3 years
Progression free survival (PFS)
The time from start of treatment until progression or death from any cause
Time frame: Throughout the study period. Approximately 3 years
Overall survival (OS)
The time from start of treatment until death from any cause.
Time frame: Throughout the study period. Approximately 3 years
Second progression free survival (PFS2)
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 frame: Throughout the study period. Approximately 3 years
Plan to share: No
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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PETHEMA Foundation