Saimai, Thailand

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

    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.

    Phase

    N/A

    Span

    41 weeks

    Sponsor

    PETHEMA Foundation

    Calahorra

    Recruiting

  • Computerized Registry of Patients With Venous Thromboembolism (RIETE)

    The RIETE Registry pretends the improvement of care of patients with thromboembolic disease. Very often the investigators pose serious doubts on how to manage a specific patient. Sometimes because it is a patient with thrombocytopenia, a pregnant woman, a patient with a recent cerebral bleeding or cerebral metastasis, a patient with gastroduodenal ulcer or hepatic cirrhosis. There is no clinical evidence about how the investigators should manage these patients and the investigators have to individualize its management. The bibliography available is not of much help. Only if the investigators have a database with a sufficient number of cases, they may be able to make evidence based decisions. This database on the Internet will allow the investigators to consult and obtain an immediate response when taking care of a patient who needs an individualized management. After introducing the patient the investigators will automatically obtain the data of all patients with similar clinical profiles. And this will help the investigators to identify high-risk patients and thus facilitate them preventing possible future complications.

    Phase

    N/A

    Span

    1401 weeks

    Sponsor

    Manuel Monreal

    Calahorra, La Rioja

    Recruiting

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