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

Phase 2

Completed

• Conditions: Relapsed or Plateau-Phase Multiple Myeloma
• Interventions: Drug: DENOSUMAB

• Registration Number: NCT00259740
• Lead Sponsor: Amgen

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.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2005-11-29
• Study First Submitted QC: 2005-11-29
• Study First Posted: 2005-12-01
• Primary Completion: 2007-08
• Disposition First Submitted: 2009-11-23
• Disposition First Submitted QC: 2009-11-23
• Disposition First Posted: 2009-11-25
• Results First Submitted: 2010-12-09
• Results First Submitted QC: 2010-12-09
• Results First Posted: 2011-01-06
• Study Completion: 2011-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-07
• Last Update Posted: 2017-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Denosumab	DENOSUMAB	-

Primary Outcome Measures

Name	Time	Method
Complete Response or Partial Response Based on M-Protein Assessments Only	Up to 18 months	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.

Secondary Outcome Measures

Name	Time	Method
Complete Response Based on M-Protein Assessments Only	Up to 18 months	Complete response based on M-protein assessments, as defined for the primary outcome measure.
Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only	Up to 18 months	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.