Non-interventional Study With Pomalidomide (Imnovid®)
Conditions
Multiple Myeloma
Conditions: official terms
Multiple Myeloma - Neoplasms, Plasma Cell
Conditions: Keywords
pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Overall Status
Recruiting
Summary
The purpose of this non-interventional study is to collect data on the efficiency and safety of pomalidomide in combination with dexamethasone in the routine application
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patients with relapsed or refractory multiple myeloma Patients must have received at least two prior lines of treatment (induction therapy followed by stem cell transplantation ± maintenance therapy is considered one prior therapy) and must have progressed under the most recent therapy regimen

- Adult male and female patients (at least 18 years with no upper age limit)

- Written informed consent to data collection and pseudonymized data transfer

- The conditions of the Pregnancy Prevention Programme must be fulfilled for all patients unless there is reliable evidence that the patient does not have childbearing potential (see summary of product characteristics Imnovid®)

- Other criteria according to summary of product characteristics Imnovid®

Exclusion Criteria:

- Missing patient's informed consent

- Pregnant or breast-feeding women

- Male patients, not capable of complying the required preventive measures (see summary of product characteristics Imnovid®)

- Other criteria according to summary of product characteristics Imnovid®
Location
iOMEDICO AG
Freiburg, Baden-Wuerttemberg, Germany
Status: Recruiting
Contact: Sina Grebhardt, PhD - 076115242 - sina.grebhardt@iomedico.com
Start Date
January 2014
Completion Date
January 2021
Sponsors
iOMEDICO AG
Source
iOMEDICO AG
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page