A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: IMNOVID

• Registration Number: NCT02164955
• Lead Sponsor: Celgene

Brief Summary

This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care.

The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Study Start: 2014-06-26
• Status Verified: 2022-10
• Primary Completion: 2022-10-10
• Study Completion: 2022-10-10
• Last Update Submitted: 2022-10-18
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 775

Inclusion Criteria

Understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the Registry.

Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment.

Exclusion Criteria

Refusal to participate in the Registry or currently participating in the treatment phase of an interventional clinical trial.

Pregnancy.

Women of childbearing potential, unless all the conditions of the pregnancy prevention program are met.

Male patients unable to follow or comply with the required contraceptive measures.

Hypersensitivity to the active substance or to any of the excipients.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Relapsed and Refractory Multiple Myeloma Patients	IMNOVID	Single Cohort of Relapsed and Refractory Multiple Myeloma Patients treated with IMNOVID (pomalidomide)

Primary Outcome Measures

Name	Time	Method
Determine incidence of risks as outlined in the Risk Management Plan	Up to 3 years	To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated multiple myeloma patients who are currently being treated with IMNOVID (pomalidomide) in a post-marketing setting.

Secondary Outcome Measures

Name	Time	Method
Pregnancy Prevention Programme Effectiveness	Up to 3 years	To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry
Previous Treatments	Approximately 6 months	To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide).

Trial Locations

Locations (122)

Cliniques Universitaires Saint Luc; 🇧🇪 Bruxelles, Avenue Hippocrate 10, Belgium

Ziekenhuis Netwerk Antwerpen- Campus Middelheim; 🇧🇪 Antwerpen, Lindendreef 1, Belgium

Az Nikolaas; 🇧🇪 Sint-Niklaas, Lodewijk De Meesterstraat 5, Belgium

Centre Hospitalier Peltzer-La Tourelle; 🇧🇪 Verviers, Rue Du Parc 29, Belgium

Centre hospitalier de Jolimont; 🇧🇪 La Louviere, Rue Ferrer 159, Belgium

Les Cliniques Du Sud Luxembourg- Clinique Saint-Joseph; 🇧🇪 Arlon, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

CHC; 🇧🇪 Liege, Belgium

Clinique Saint-Pierre; 🇧🇪 Ottignies, Belgium

Odense Hospital; 🇩🇰 Odense, Kloevervanget 10, Denmark

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