Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
Primary Purpose
Relapsed or Plateau-Phase Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
DENOSUMAB
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed or Plateau-Phase Multiple Myeloma focused on measuring Multiple Myeloma, Relapsed, Plateau-Phase
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Denosumab
Arm Description
Outcomes
Primary Outcome Measures
Complete Response or Partial Response Based on M-Protein Assessments Only
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
Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
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
Complete response based on M-protein assessments, as defined for the primary outcome measure.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00259740
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Plateau-Phase Multiple Myeloma
Keywords
Multiple Myeloma, Relapsed, Plateau-Phase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Denosumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
DENOSUMAB
Intervention Description
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 Outcome Measure Information:
Title
Complete Response or Partial Response Based on M-Protein Assessments Only
Description
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.
Time Frame
Up to 18 months
Secondary Outcome Measure Information:
Title
Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only
Description
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.
Time Frame
Up to 18 months
Title
Complete Response Based on M-Protein Assessments Only
Description
Complete response based on M-protein assessments, as defined for the primary outcome measure.
Time Frame
Up to 18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19714603
Citation
Vij R, Horvath N, Spencer A, Taylor K, Vadhan-Raj S, Vescio R, Smith J, Qian Y, Yeh H, Jun S. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009 Oct;84(10):650-6. doi: 10.1002/ajh.21509.
Results Reference
background
Links:
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
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