Non-interventional Study With Pomalidomide (Imnovid®)

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT02075996
• Lead Sponsor: iOMEDICO AG

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-11
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Primary Completion: 2021-02-04
• Study Completion: 2021-02-04
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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®

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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®

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	6 years

Secondary Outcome Measures

Name	Time	Method
secondary malignancies	6 years	long term safety is focused on secondary malignancies
adverse reaction profile	3 years
relative dose intensity of pomalidomide and dexamethasone	3 years
explore additional supportive therapies	3 years	To explore additional supportive therapies used on this patient population (e.g. G-CSF, antibiotics, DVT prophylaxis)
Time to Treatment Discontinuation (TTD)	6 years
Time to next treatment (TNT)	6 years
overall Survival (OS)	6 years
Overall Response Rate (ORR)	6 years
assess changes in myeloma-related quality of life	3 years

Trial Locations

Locations (1)

iOMEDICO AG; 🇩🇪 Freiburg, Baden-Wuerttemberg, Germany