Study of BHQ880 plus zoledronic acid in relapsed/refractory myeloma

• Research type

  Research Study

• Full title

  A Phase 1b multicentre dose-determination study, with an adaptive randomized, double-blind, phase II, using various repeated i.v. doses of BHQ880 in combination with zoledronic acid in relapsed or refractory myeloma patients with prior skeletal-related event

• IRAS ID

  15578

• Contact name

  Steve Schey

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-000411-15

• 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. In this clinical trial, up to 252 patients with relapsed or refractory MM, who have had at least one skeletal-event, will be randomised to treatment with BHQ880 (given i.v. in various doses not exceeding 40 mg/kg) plus i.v. zoledronic acid or i.v. placebo plus i.v. zoledronic acid, given every 28 days for at least 9 months. The objectives of the study are to assess the efficacy, safety, pharmacokinetics and pharmacodynamics of BHQ880 and determine the doses to use in future studies.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/65

• Date of REC Opinion

  6 Aug 2009

• REC opinion

  Further Information Favourable Opinion