Pomalidomide in Relapsed and/or Refractory Multiple Myeloma Patients

• Research type

  Research Study

• Full title

  A MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY WITH POMALIDOMIDE IN COMBINATION WITH LOW DOSE DEXAMETHASONE IN SUBJECTS WITH REFRACTORY OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA

• IRAS ID

  109141

• Contact name

  Gordon Cook

• Sponsor organisation

  Celgene Corporation

• Eudract number

  2012-001888-78

• Research summary

  Multiple Myeloma is a rare incurable cancer of plasma cells (type of white blood cells in the bone marrow). The cause of the disease is unknown. Multiple Myeloma affects about 4,000 people in the UK each year. Most cases occur in people aged 50 and older, and very rarely in younger adults. The sponsor of this study, Celgene, wishes to further study their developed drug Pomalidomide (POM) in combination with a low dose of the drug Dexamethasone (LD-DEX) in patients who suffer from Multiple Myeloma, and who??s disease has worsened after initial treatment, or has returned and worsened. This is an international study involving approximately 500 people and will consist of screening, treatment and a follow up phase which can last up to 5 years. Patients may receive the following medication: ?½ oral (per mouth) POM at starting dose of 4mg on Days 1-21 of a 28 day cycle in combination with?½ oral LD-DEX at starting dose of 40mg/day for patients age 75 and younger and or 20mg/day for patients older than age 75 on Days 1, 8, 15 and 22 of a 28-day cycle. Tests to be performed during the study include evaluation of the disease stage within the bone marrow (mandatory) and a skeletal survey (X-ray review of the bony body parts affected by the disease). Patients will receive treatment as long as they benefit from the study drug or do not suffer severe side effects. The safety of Pomalidomide was already tested in previous studies and will be further evaluated in this third stage study in combination with LD-DEX, including the efficacy of this particular combination therapy. Celgene also aims to study the individual patient??s response to the study drug and genetic disease relations and reactions in this particular patient group.

• REC name

  HSC REC B

• REC reference

  12/NI/0154

• Date of REC Opinion

  19 Dec 2012

• REC opinion

  Further Information Favourable Opinion