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A Phase Ib multicenter dose-determination study, with an adaptive, randomized, placebo-controlled, double-blind phase II, using various repeated IV doses of BHQ880 in combination with zoledronic acid ...

Mise à jour : Il y a 4 ans
Référence : EUCTR2008-000411-15

A Phase Ib multicenter dose-determination study, with an adaptive, randomized, placebo-controlled, double-blind phase II, using various repeated IV doses of BHQ880 in combination with zoledronic acid in relapsed or refractory myeloma patients with prior skeletal-related event

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Extrait

Escalation phase (Phase I): 1. To determine the maximum-tolerated dose (MTD) and to characterize dose limiting toxicity (DLT) of escalating doses of BHQ880 (up to a maximum dose of 20 mg/kg) in combination with standard anti-myeloma therapy and zoledronic acid. Expansion phase (Phase II): 1. To determine one or more doses of BHQ880 for further development based on dose-efficacy modeling, where efficacy is relative to placebo in terms of time to first SRE from randomization and change in bone markers for bone resorption and formation in combination with zoledronic acid plus standard anti-myeloma therapy.

Critère d'inclusion

  • Relapsed or refractory multiple myeloma patients with at least one prior SRE scheduled for standard anti-myeloma therapy and bisphosphonates

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