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A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00928486
First received: June 9, 2009
Last updated: May 6, 2016
Last verified: May 2016
Results First Received: May 6, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Drug: Lenalidomide
Drug: Dexamethasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Lenalidomide and Dexamethasone Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.

Participant Flow:   Overall Study
    Lenalidomide and Dexamethasone  
STARTED     25  
Efficacy Evaluable (EE)     24 [1]
COMPLETED     15 [2]
NOT COMPLETED     10  
Adverse Event                 2  
Disease Progression                 7  
Withdrawal by Subject                 1  
[1] EE population = given at least 1 dose of study drug, evaluated for efficacy and met eligibility
[2] Completed = those who continued responding to treatment; upon marketing approval, given lenalidomide



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety Population = includes all participants who received at least one dose of study drug

Reporting Groups
  Description
Lenalidomide and Dexamethasone Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.

Baseline Measures
    Lenalidomide and Dexamethasone  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Mean (Standard Deviation)
  62.1  (9.99)  
Gender  
[units: participants]
 
Female     13  
Male     12  
Region of Enrollment  
[units: participants]
 
Japan     25  



  Outcome Measures
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1.  Primary:   Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)   [ Time Frame: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks ]

2.  Secondary:   Myeloma Response Rate   [ Time Frame: From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeks ]

3.  Secondary:   Kaplan-Meier Estimates of Duration of Response (DoR)   [ Time Frame: From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Anne McClain, Senior Manager, Clinical Trial Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: ClinicalTrialDisclosure@celgene.com



Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00928486     History of Changes
Other Study ID Numbers: CC-5013-MM-022
Study First Received: June 9, 2009
Results First Received: May 6, 2016
Last Updated: May 6, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency