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Trial record 2 of 7 for:    Xgeva | myeloma

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

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ClinicalTrials.gov Identifier: NCT00259740
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : January 6, 2011
Last Update Posted : March 15, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Relapsed or Plateau-Phase Multiple Myeloma Drug: DENOSUMAB Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : November 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Denosumab

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.


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

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00259740     History of Changes
Obsolete Identifiers: NCT00337363
Other Study ID Numbers: 20050134
First Posted: December 1, 2005    Key Record Dates
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
Denosumab
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
Bone Density Conservation Agents
Physiological Effects of Drugs