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

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

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.

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

Conditions
-----------------
Relapsed or Plateau-Phase Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: DENOSUMAB


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br> | Drug: DENOSUMAB<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma, Relapsed, Plateau-Phase