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OpenTrials
Completed

NCT Number: NCT00259740

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

The purpose of this study is to determine if denosumab is effective in the treatment of relapsed or plateau-phase multiple myeloma.

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Key information

Conditions

Relapsed or Plateau-Phase Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Denosumab

Drug

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

An Open-Label, Multi-Center Phase 2 Trial of Denosumab in the Treatment of Relapsed or Plateau-Phase Multiple Myeloma

Important dates

Study start
2005
Primary completion
2007
Study completion
2011
First posted
Dec 1, 2005
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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