A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
Pomalidomide, Multiple Myeloma, Relapsed, Refractory, Observational, Imnovid, Registry, Post-approval, Safety
Study Type
Observational [Patient Registry]
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: IMNOVID
Type: Drug
Overall Status
Recruiting
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 up prospectively for up to 3 years following the end of pomalidomide treatment. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Locations
Vejle Hospital, Dep of hema Kabbeltoft, Kabbeltoft 25
Vejle, Denmark
Status: Not yet recruiting
Medizinische Klinik II, DIAKO Ev., Diakonie-Krankenhausgemeinnützige
Bremen, Germany
Status: Not yet recruiting
Klinikum Frankfurt Höchst, Klinik für Innere Medizin 3
Frankfurt, Germany
Status: Recruiting
GP Dres. Verpoort
Hamburg, Germany
Status: Not yet recruiting
Klinik für Hämatologie, Onkologie und Palliativmedizin Mühlenkreiskliniken, Johannes Wesling Klinikum Minden
Minden, Germany
Status: Not yet recruiting
Gemeinschaftspraxis für, Hämato-Onkologie am St. Josef, Krankenhaus Moers
Moers, Germany
Status: Not yet recruiting
Zentrum für Innere Medizin
Mutlangen, Germany
Status: Not yet recruiting
Onkologische Schwerpunktpraxis Speyer
Speyer, Germany
Status: Not yet recruiting
Start Date
June 2014
Completion Date
November 2019
Sponsors
Celgene Corporation
Source
Celgene Corporation
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page