MEDI4736-MM-003 Phase 2 Relapsed and Refractory Multiple Myeloma

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Open-label, Study to Determine the Safety and Efficacy for the Combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (FUSION MM-003)

• IRAS ID

  206466

• Contact name

  James Cavenagh

• Contact email

  j.d.cavenagh@qmul.ac.uk

• Sponsor organisation

  Celgene International II Sàrl

• Eudract number

  2016-001209-17

• Clinicaltrials.gov Identifier

  30686, NIHR Clinical Research Network reference number

• Duration of Study in the UK

  2 years, 4 months, 22 days

• Research summary

  This is a randomised, multicentre, open-label, Phase 2 study evaluating the safety and efficacy for the combination of Durvalumab (DURVA) and Daratumumab (DARA) (D2) in two separate cohorts.

  • Cohort 1: Durvalumab and Daratumumab (D2)
  • Cohort 2: Durvalumab and Daratumumab plus Pomalidomide and Dexamethasone (PD3)

  Multiple myeloma (MM) is a rare and incurable progressive neoplastic disease (a new and abnormal growth of tissue in a part of the body, especially as a characteristic of cancer) that accounts for 10% of all haematological malignancies (cancer of one or more of the components of blood). It has been estimated that 62,469 new cases and 43,091 deaths from MM occurred globally in 2012.
  Despite the progress in treatment options for MM, the disease follows a relapsing course in the majority of patients, regardless of treatment regimen or initial response to treatment. Multiple myeloma remains incurable using conventional treatments, with an overall 5-year relative survival rate of 45%. New therapies are needed to treat Relapsed and Refractory Multiple Myeloma (RRMM) patients.

  The main purpose of this study to determine how safe and effective the combination of durvalumab and daratumumab is for patients with RRMM.

  Approximately 144 patients with RRMM will be enrolled worldwide into the following cohorts:

  • D2 Cohort 112 patients
  • PD3 Cohort 32 patients

  The total duration of the study is expected to last approximately 28 months, from first patient enrolled until last patient last visit.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  16/LO/1022

• Date of REC Opinion

  28 Jun 2016

• REC opinion

  Further Information Favourable Opinion