Daratumumab with bortezomib and dexamethasone in multiple myeloma

• Research type

  Research Study

• Full title

  An Open label, International, Multicenter, Dose Escalating Phase I/II Trial Investigating the Safety of Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Relapsed or Refractory Multiple Myeloma

• IRAS ID

  103212

• Contact name

  Jamie Cavenagh

• Sponsor organisation

  Genmab A/S

• Eudract number

  2011-005692-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Multiple myeloma (MM) is a cancer of the plasma cells in bone marrow which accounts for approximately 1% of all malignancies. There is no cure available. Treating MM with combination therapy has been more effective than single-agent therapy. In the majority of patients with MM, the malignant plasma cells produce an identical deficient protein. A new human antibody called daratumumab recognises this impaired protein and previous studies combining a direct antitumour agent, such as this, with indirect antitumour agents have shown an improved effect in the treatment of MM. Therefore, daratumumab is being tested with bortezomib, a proteasome inhibitor, and dexamethasone, an anti-inflammatory drug, in patients with relapsed or refractory multiple myeloma. The trial has two parts and patients will participate in either Part 1 or Part 2. Part 1 will test the safety of increasing doses of daratumumab in combination with bortezomib and dexamethasone in 21-day treatment cycles. Part 2 will further explore the safety, effectiveness and action within the body of the maximum tolerated dose of daratumumab. Daratumumab is given by infusion. Overall, subjects could be in the trial for up to 53 weeks (including 8 treatment cycles of 21 days and 6 months of follow up) and visit the study centre 43 times (4-6 visits in cycles 1-8, and monthly during follow up). Blood samples and 24-hour urine collection will be performed throughout the study. Whole body x-rays or computed tomography (CT) scans and bone marrow biopsies will also be performed at the beginning of the study, if not performed recently, and doctors may also decide these are necessary at the beginning of each subsequent cycle and at the end of the trial. The study will include a maximum of 60 patients across the U.S. and Europe. A pharmaceutical company is funding this study.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0594

• Date of REC Opinion

  26 May 2012

• REC opinion

  Further Information Favourable Opinion