LTS17704

• Research type

  Research Study

• Full title

  International, multi-center, open-label, treatment extension study in patients with multiple myeloma who are still benefitting from study.-based therapy following completion of a Phase 1, 2, or 3 parental study

• IRAS ID

  1006805

• Contact name

  Kwee Yong

• Contact email

  kwee.yong@ucl.ac.uk

• Sponsor organisation

  Sanofi-aventis recherche & développement

• Eudract number

  2022-002253-26

• Clinicaltrials.gov Identifier

  NCT05669989

• Research summary

  The sponsor is going to run an international treatment-extension study in adults with multiple myeloma and who have derived clinical benefits from Isatuximab in Isatuximab phase 1, 2, and 3 study parental studies. Only ICARIA EFC14335 study is applicable to the UK. The rationale for this study, is to provide continued access to Isatuximab to patients for which study objectives are completed and who, in the opinion of the treating physician, would benefit from continuation of therapy with Isatuximab. The primary objective of this study is to assess the long-term safety of Isatuximab administered as a monotherapy or in combination regimens in patients previously treated with Isatuximab. One subject that previously participated in the parental study is expected to be enrolled in the study intervention at a UK NHS oncology site 8260001 Dr Kwee Young, at UCL, Huntley Street, London WC1E6AG.
  The study entails 3 stages that includes: The screening period that is within 14 days prior to the first dose in the treatment extension study and starts with ICF signature. Treatment period is defined as the period from the first study intervention administration to the last study intervention administration +30 days. Post period is defined as the time starting 31 days after the last study intervention is administered to the end of study or death, whichever comes first. No follow-up visits are planned except when deemed necessary by the investigator, especially in case a related AE (serious or not) or a serious AE (related or not) is still ongoing 30 days after the last study intervention administration. Such AEs will be followed until recovery or stabilization.

• REC name

  South Central - Oxford B Research Ethics Committee

• REC reference

  23/SC/0078

• Date of REC Opinion

  14 Aug 2023

• REC opinion

  Further Information Favourable Opinion