Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab

An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma

The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

Patients who have relapsed myeloma have failed treatment regimens and have had disease progression following their last treatment regimen. Despite newer salvage therapies, their treatment options are limited and may include best supportive care and investigational therapy. Patients with plateau-phase myeloma have a stabilized serum M-protein level without further tumor regression despite continued treatment. Recent evidence suggests that their prognosis might improve with further reduction in serum M-protein or prolongation of time to disease progression (TTP). These patients are candidates for investigational agents that could further reduce tumor burden or increase TTP.

Inclusion Criteria:

• age ≥ 18 years
• clinical diagnosis of relapsed or plateau-phase multiple myeloma
• measurable disease (>0.5 g/dL) as determined by special blood tests
• ECOG 0 or 1

Exclusion Criteria:

• newly diagnosed myeloma
• non-secretory myeloma
• plasma cell leukemia or plasma cell dyscrasia with POEMS syndrome
• prior allogeneic stem cell transplant
• administration of oral or IV bisphosphonates within 2 weeks of enrollment to study

Other criteria also apply.