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

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT02902900
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-01
• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-16
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2504

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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

Name	Time	Method
Time to Progression (TTP)	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.
Overall Response Rate (ORR)	Up to 2 years	Is defined by at least a partial response (PR) according to IMWG criteria
Duration of Response (DOR)	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)	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 Treatment Failure (TTF)	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)	Up to 3 years	Number of subjects with adverse events

Trial Locations

Locations (120)

Centre Hospitalier General; 🇫🇷 Saint Germain En Laye, France

Groupe Hospitalier Sud; 🇫🇷 Amiens Cedex 1, France

Hotel Dieu; 🇫🇷 Angers Cedex 9, France

Ch D'Arras; 🇫🇷 Arras Cedex, France

Centre Hospitalier Intercommunal Robert Ballanger; 🇫🇷 Aulnay Sous Bois, France

Centre Hospitalier H. Duffaut; 🇫🇷 Avignon Cedex 9, France

Centre Hospitalier Jeanne d'Arc; 🇫🇷 Bar Le Duc Cedex, France

Chic Cote Basque Bayonne; 🇫🇷 Bayonne Cedex, France

Hopital Nord Franche-Comte - Site de Belfort; 🇫🇷 Belfort Cedex, France

Hopital Jean Minjoz; 🇫🇷 Besancon Cedex, France

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