Retrospective Study of the Use of Belantamab Mafodotin (Blenrep®) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) in Spain.

Sponsor
PETHEMA Foundation
Study ID
NCT05297240
Status
Unknown

Conditions

  • RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belantamab mafodotin — DRUG
    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.

Study Details

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).

Key Dates

Start date
Mar 24, 2022
Status verified
Aug 2022
Primary completion
Dec 31, 2022
Completion
Dec 31, 2022

Study Design

Enrollment
170 participants (estimated)

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: Throughout the study period. Approximately 3 years ]

Central Contacts

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