This trial is active, not recruiting.

Condition relapsed or plateau-phase multiple myeloma
Treatment denosumab
Phase phase 2
Sponsor Amgen
Start date November 2005
End date August 2007
Trial size 96 participants
Trial identifier NCT00259740, 20050134, NCT00337363


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

Complete Response or Partial Response Based on M-Protein Assessments Only
time frame: Up to 18 months

Secondary Outcomes

Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
time frame: Up to 18 months
Complete Response Based on M-Protein Assessments Only
time frame: Up to 18 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Amgen.