Spots Global Cancer Trial Database for Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab

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Trial Identification

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

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

Study ID: NCT00259740

Conditions

Relapsed or Plateau-Phase Multiple Myeloma

Interventions

DENOSUMAB

Study Description

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

Detailed Description: 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.