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Completed

NCT Number: NCT02902900

An Efficacy Study of Pomalidomide in Patient With Multiple Myeloma in Routine Clinical Practice

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier General, Albi, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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, 2019,
  • 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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study title

Observational Cohort Study Evaluating the Use and Efficacy of Pomalidomide in Patients With Multiple Myeloma in Routine Clinical Practice

Acronym: MIROIR

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2016
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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