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Trial record 1 of 1 for:    NCT02902900
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An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice (MIROIR)

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ClinicalTrials.gov Identifier: NCT02902900
Recruitment Status : Recruiting
First Posted : September 16, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

Tracking Information
First Submitted Date September 13, 2016
First Posted Date September 16, 2016
Last Update Posted Date November 15, 2018
Actual Study Start Date September 25, 2015
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2016)
Progression Free Survival (PFS) [ Time Frame: Up to approximately 6 months ]
Is defined as the time between the date of treatment initiation with pomalidomide and the date of the first progression according to the International Myeloma Working Group (IMWG) criteria or death whatever the cause.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02902900 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 13, 2016)
  • Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    Is defined by at least a partial response (PR) according to IMWG criteria
  • Duration of Response (DOR) [ Time Frame: Up to 2 years ]
    Is calculated for responders with at least partial response (PR) as the time between the first observation of response and the time of the first event such as disease progression or death due to progression.
  • Overall Survival (OS) [ Time Frame: Up to 2 years ]
    Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.
  • Time to Progression (TTP) [ Time Frame: Up to 2 years ]
    Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.
  • Time to Treatment Failure (TTF) [ Time Frame: Up to 2 Years ]
    Is defined as the duration between the date of the start of pomalidomide treatment and the first progression according to IMWG criteria, second cancer, toxicity requiring treatment discontinuation or death of the patient.
  • Adverse Events (AEs) [ Time Frame: Up to 3 years ]
    Number of subjects with adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice
Official Title Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
Brief Summary

This study, a national, multicenter, observational, ambispective, non-interventional study, will be conducted in French hospitals prescribing pomalidomide and already participating in the ongoing Imnovid registry.

This study will add to the registry. Indeed, pomalidomide-prescribing physicians and pharmacists dispensing pomalidomide have to enter into the Imnovid registry all patients who have been prescribed this drug since the date on which it was marketed regardless of the initiation date of pomalidomide or the indication for which it was prescribed.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The MIROIR study focuses on multiple myeloma patients treated with pomalidomide in France whose treatment was initiated between October 1, 2014, and September 30, 2017. Patients having initiated pomalidomide outside of this period or having received pomalidomide in a previous treatment line will not be included.
Condition Multiple Myeloma
Intervention Not Provided
Study Groups/Cohorts Imnovid
Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2016)
3000
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2020
Estimated Primary Completion Date September 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patient (age ≥ 18 yrs),
  • Diagnosed with multiple myeloma (measurable or not),
  • In whom pomalidomide treatment was first initiated between October 1, 2014, and September 30, 2017,
  • Patient already included in the Imnovid registry,
  • Having received oral and written information about the study, and having given their consent to participate.

Exclusion Criteria:

  • Previous participation in a clinical trial with pomalidomide,
  • Treatment with pomalidomide in a previous line,
  • Simultaneous participation in a clinical trial.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02902900
Other Study ID Numbers CC-4047-MM-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Celgene
Study Sponsor Celgene
Collaborators Not Provided
Investigators
Study Director: Pierre Lauvray Celgene France
PRS Account Celgene
Verification Date November 2018