Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma|
- Complete Response or Partial Response Based on M-Protein Assessments Only [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]Complete response or partial response based on serum M-Protein assessments. Complete response is defined as absence of original M-protein in serum by immunofixation, and partial response is defined as ≥ 50% reduction from baseline in serum M-protein, both maintained for a minimum of 6 weeks.
- Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]Complete response, partial response or minimal response based on serum M-protein assessments. Complete and partial responses are as defined for the primary outcome measure. Minimal response is defined as 25 to 49% reduction from baseline in serum M-protein level, maintained for a minimum of 6 weeks.
- Complete Response Based on M-Protein Assessments Only [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]Complete response based on M-protein assessments, as defined for the primary outcome measure.
|Study Start Date:||November 2005|
|Study Completion Date:||December 2011|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259740