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

Celgene2,504 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,504

Conditions

Multiple Myeloma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (126)

Outcomes

Primary Outcomes

Progression Free Survival (PFS)

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.

Time frame: Up to approximately 6 months

Secondary Outcomes

Overall Response Rate (ORR)

Is defined by at least a partial response (PR) according to IMWG criteria

Time frame: Up to 2 years

Duration of Response (DOR)

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.

Time frame: Up to 2 years

Overall Survival (OS)

Is defined as the duration between the date of the start of treatment and the date of death whatever the cause.

Time frame: Up to 2 years

Time to Progression (TTP)

Is defined as the time between the start of pomalidomide treatment and disease progression according to IMWG criteria, or death due to progression.

Time frame: Up to 2 years

Time to Treatment Failure (TTF)

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.

Time frame: Up to 2 Years

Adverse Events (AEs)

Number of subjects with adverse events

Data from ClinicalTrials.gov

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Centre Hospitalier General

Albi, France

Groupe Hospitalier Sud

Amiens, France

Hotel Dieu

Angers, France

Ch D'Arras

Arras, France

Centre Hospitalier Intercommunal Robert Ballanger

Aulnay-sous-Bois, France

Centre Hospitalier H. Duffaut

Avignon, France

Centre Hospitalier Jeanne d'Arc

Bar-le-Duc, France

Chic Cote Basque Bayonne

Bayonne, France

Hopital Nord Franche-Comte - Site de Belfort

Belfort, France

Hopital Jean Minjoz

Besançon, France

...and 116 more locations