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NCT02075996 Clinical Trial

Non-interventional Study With Pomalidomide (Imnovid®)

Multiple Myeloma Clinical Trial

— Poseidon  

Official title:
Non-interventional Study of Pomalidomide (Imnovid®) in Combination With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02075996
Other study ID # IOM-10280
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2014
Est. completion date February 4, 2021

Study information
Verified date August 2022
Source iOMEDICO AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 151
Est. completion date February 4, 2021
Est. primary completion date February 4, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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®

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany iOMEDICO AG Freiburg Baden-Wuerttemberg

Sponsors (1)
Lead Sponsor Collaborator
iOMEDICO AG

Country where clinical trial is conducted

Germany, 

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