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

NCT00259740 | Completed Phase 2 Results

• 1 other identifier: 20050134
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Relapsed or Plateau-Phase Multiple Myeloma

Keywords

Multiple Myeloma, Relapsed, Plateau-Phase

Outcome Measures

Primary Outcomes (1)

• Complete Response or Partial Response Based on M-Protein Assessments Only

  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.

  Up to 18 months

Secondary Outcomes (2)

• Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only

  Up to 18 months

• Complete Response Based on M-Protein Assessments Only

  Up to 18 months

Study Arms (1)

Denosumab

EXPERIMENTAL

Drug: DENOSUMAB

Interventions

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.

Denosumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Related Publications (1)

• Vij R, Horvath N, Spencer A, Taylor K, Vadhan-Raj S, Vescio R, Smith J, Qian Y, Yeh H, Jun S. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009 Oct;84(10):650-6. doi: 10.1002/ajh.21509.

  PMID: 19714603 BACKGROUND

Related Links

• Notice regarding posted summaries of trial results
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2005
• First Posted: December 1, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: December 1, 2011
• Last Updated: March 15, 2017
• Results First Posted: January 6, 2011

Record last verified: 2017-02