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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259740
First Posted: December 1, 2005
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amgen
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: November 29, 2005
First Posted: December 1, 2005
Results First Submitted: December 9, 2010
Results First Posted: January 6, 2011
Last Update Posted: March 15, 2017
Last Verified: February 2017

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
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs