Study of a new drug for untreated multiple myeloma patients - V00

• Research type

  Research Study

• Full title

  A double-blind, placebo-controlled, randomized Phase 2 study of BHQ880, an anti-Dickkopf1 (DKK1) monoclonal antibody (mAb), in patients with untreated multiple myeloma and renal insufficiency

• IRAS ID

  80013

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009-010875-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Bone pain, hypercalcaemia and pathological fractures are important causes of morbidity and mortality in patients with multiple myeloma (MM). Bisphosphonates, including zoledronic acid, are used to prevent loss of bone and, thereby, limit these problems. However, it has been estimated that, even with bisphophonate treatment, at the time of relapse,approximately 50% of MM patients have the signs and symptoms of bone disease. BHQ880, works differently from bisphosphonates, stimulating the production of normal bone-making cells (osteoclasts)and has the potential for ameliorating MM-associated bone disease. In-vitro studies demonstrate that BHQ880 may also possess anti-myeloma activity.This study will evaluate the effects of BHQ880 in upto 144 patients patients with previously untreated multiple myeloma and renal insufficiency with a creatinine clearance less than 30 ml/min who are not considered candidates for bisphosphonate therapy. This will enable direct evaluation of the potential anabolic bone (bone adding) effects of BHQ880 in the absence of agents, like bisphosphonates,that can indirectly modulate osteoblast activity. The primary objective of the study will be to evaluate the effect of BHQ880 in combination with bortezomib and dexamethasone,considered first-line standard of care, compared to placebo administered with the combination on the time to first SRE on study, defined as a pathologic fracture, spinal cord compression, or radiation or surgery to the bone.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  11/SC/0273

• Date of REC Opinion

  27 Jul 2011

• REC opinion

  Favourable Opinion