CEPHEUS

• Research type

  Research Study

• Full title

  A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) with VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects with Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

• IRAS ID

  251477

• Contact name

  Hannah Hunter

• Contact email

  hannahhunter@nhs.net

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2018-001545-13

• Duration of Study in the UK

  6 years, 2 months, 31 days

• Research summary

  This is a research study in 360 adults with multiple myeloma. Multiple myeloma is a rare type of bone marrow cancer that can be controlled by some current
  treatments, but there is currently no cure. Multiple myeloma affects the plasma
  cells inside the bone marrow, causing these to grow out of control. This damages the bones and affects the production of healthy blood cells. Treatments for multiple myeloma currently include combination chemotherapy,proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs), high-dose chemotherapy, and stem cell support.

  The purpose of this study is to find out how well Daratumumab works when it is given along with three other drugs called Velcade (Bortezomib), Lenalidomide and Dexamethasone compared to the drug combination of Velcade (Bortezomib), Lenalidomide and Dexamethasone (VRd) in newly diagnosed multiple myeloma patients who are not suitable for stem cell transplant.
  
  Velcade (Bortezomib), Lenalidomide, and Dexamethasone (VRd) is a combination of drugs already used to treat Multiple Myeloma and is considered a Standard of Care for treating some Multiple Myeloma patients in some countries although it is not currently available on the NHS for UK patients.

  The study is conducted in three phases: screening, treatment and follow-up. Screening will last up to four weeks, to check whether the patient is eligible. Treatment period will comprise 21 or 28 day cycles – half of the patients will receive daratumumab subcutaneously in combination with VRd, and half will receive VRd. Patients will be treated until their disease progresses and will after this followed-up will continue until the end of the study which is planned to be roughly 7 years.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  18/EM/0336

• Date of REC Opinion

  3 Dec 2018

• REC opinion

  Further Information Favourable Opinion