Non-interventional Study With Pomalidomide (Imnovid®) (Poseidon)

iOMEDICO

Status: Completed

Conditions: Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT02075996

IOM-10280

Details and patient eligibility

About

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

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®

Trial design

151 participants in 2 patient groups

Pomalidomide following lenalidomide

Description:

75 patients with pomalidomide directly following lenalidomide treatment

Pomalidomide following other therapy

Description:

75 patients with pomalidomide following any other prior therapy. This includes lenalidomide in earlier lines than the most recent line.