Open-Label, Phase 2, Proof of Concept Study in Multiple Myeloma - Denosumab
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00259740|
Recruitment Status : Completed
First Posted : December 1, 2005
Results First Posted : January 6, 2011
Last Update Posted : March 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Relapsed or Plateau-Phase Multiple Myeloma||Drug: DENOSUMAB||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||96 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||August 2007|
|Study Completion Date :||December 2011|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259740