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

NCT05297240 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 170

Last updated 2022-08-05

No results posted yet for this study

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).

Conditions

  • RELAPSED AND/OR REFRACTORY MULTIPLE MYELOMA

Interventions

DRUG

Belantamab 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 & Collaborators

Principal Investigators

  • Javier de la Rubia · HOSPITAL LA FE VALENCIA

  • Adrián Alegre · Hospital La Princesa (Madrid)

  • María Victoria Mateos · Hospital Clínico, Salamanca

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Spain

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05297240 on ClinicalTrials.gov