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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

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.


Condition or disease
Multiple Myeloma

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice
Actual Study Start Date : September 25, 2015
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Group/Cohort
Imnovid
Patients relapse/ refractory multiple myeloma who initiated pomalidomide in routine clinical practice



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 2 years ]
    Is defined by at least a partial response (PR) according to IMWG criteria

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Adverse Events (AEs) [ Time Frame: Up to 3 years ]
    Number of subjects with adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902900


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

  Show 126 Study Locations
Sponsors and Collaborators
Celgene
Investigators
Study Director: Pierre Lauvray Celgene France

Additional Information:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02902900     History of Changes
Other Study ID Numbers: CC-4047-MM-018
First Posted: September 16, 2016    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018

Keywords provided by Celgene:
Multiple Myeloma
Pomalidomide
Efficacy

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Pomalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents