Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Amgen.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00259740
First received: November 29, 2005
Last updated: January 20, 2011
Last verified: January 2011
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Purpose
The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Relapsed or Plateau-Phase Multiple Myeloma |
Drug: DENOSUMAB |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Multiple Myeloma
Drug Information available for:
Denosumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 96 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | February 2012 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Denosumab |
Drug: DENOSUMAB
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00259740 History of Changes |
| Obsolete Identifiers: | NCT00337363 |
| Other Study ID Numbers: | 20050134 |
| Study First Received: | November 29, 2005 |
| Results First Received: | December 9, 2010 |
| Last Updated: | January 20, 2011 |
| Health Authority: | Australia: Therapeutic Goods Administration United States: Food and Drug Administration |
Keywords provided by Amgen:
|
Multiple Myeloma, Relapsed, Plateau-Phase |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013