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

Relapsed or Plateau-Phase Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259740
• Other study ID #: 20050134
• Status: Completed
• Phase: Phase 2
• First received: November 29, 2005
• Last updated: September 12, 2014
• Start date: November 2005
• Est. completion date: December 2011

Study information

• Verified date: September 2014
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Other known NCT identifiers

• NCT00337363

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Plateau-Phase Multiple Myeloma

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & 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.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Complete Response, Partial Response or Minimal Response Based on M-Protein Assessments Only	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.	Up to 18 months	No
Secondary	Complete Response Based on M-Protein Assessments Only	Complete response based on M-protein assessments, as defined for the primary outcome measure.	Up to 18 months	No

External Links

•   AmgenTrials clinical trials website