Conditions: Relapsed or Plateau-Phase Multiple Myeloma
Keywords: Multiple Myeloma, Relapsed, Plateau-Phase
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 96
Healthy volunteers: no

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.

Arms:
arm 1: None

Interventions: intervention 1: DENOSUMAB
Intervention descriptions: intervention 1: 120 mg administered subcutaneously on study days 1, 8, 15, and 29 and every 28 days thereafter. Each dose will be administered in two separate injections of 60 mg (1.0 mL) each.

Protocol document: