JDCG Tabalumab with Bortezomib and Dexamethasone in Multiple Myeloma

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study of Tabalumab in Combination with Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma

• IRAS ID

  99210

• Contact name

  Majid Kazmi

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2011-005103-32

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Despite treatment advances over the past decade, Multiple Myeloma (MM) remains an incurable cancer. Bortezomib is an established therapy used alone and with Dexamethasone. It also shows promise as a treatment with other therapies including Melphalan and Prednisone in a first line setting. Therefore more treatments are needed to increase patient responses and prolong disease control for people with Multiple Myeloma (MM). Tabalumab is a potent and selective fully human antibody which has a neutralizing effect against the cells that cause Multiple Myeloma (MM). Tabalumab has been studied in patients with Rheumatoid Arthritis (RA) and Systematic Lupus Erythematosus (SLE or Lupus)and studies are currently ongoing in these areas. To be eligible for enrollment in this study patients must be at least 18 years old with active Multiple Myeloma (MM) that has been previously treated with at least 1 and no more than 3 therapies. It is estimated that each participant will receive 8 cycles of study treatment lasting between 6 and 8 months. The entire study will last for approximately 36 months. Study assessments will include: Physical examinations, blood tests, urine tests, X-rays, ECGs and Questionnaires.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/0873

• Date of REC Opinion

  13 Aug 2012

• REC opinion

  Further Information Favourable Opinion