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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00259740
First received: November 29, 2005
Last updated: September 12, 2014
Last verified: September 2014
  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: 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:


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
Study Completion Date: December 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259740

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
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: September 12, 2014
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014