Non-interventional Study With Pomalidomide (Imnovid®)

NCT ID: NCT02075996

Last Updated: 2022-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

151 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-11

Study Completion Date

2021-02-04

Brief Summary

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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

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Conditions

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Multiple Myeloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pomalidomide following lenalidomide

75 patients with pomalidomide directly following lenalidomide treatment

No interventions assigned to this group

Pomalidomide following other therapy

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

No interventions assigned to this group

Eligibility Criteria

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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®
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tobias Dechow, PhD

Role: PRINCIPAL_INVESTIGATOR

practice based oncology office Ravensburg

Locations

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iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

References

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Dechow T, Aldaoud A, Behlendorf T, Knauf W, Eschenburg H, Groschek M, Hansen R, Soling U, Grebhardt S, Siebenbach HU, Vannier C, Potthoff K. Pomalidomide plus dexamethasone for patients with relapsed or refractory multiple myeloma: Final results of the non-interventional study POSEIDON and comparison with the pivotal phase 3 clinical trials. Eur J Haematol. 2022 Feb;108(2):133-144. doi: 10.1111/ejh.13719. Epub 2021 Nov 15.

Reference Type DERIVED
PMID: 34714555 (View on PubMed)

Other Identifiers

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IOM-10280

Identifier Type: -

Identifier Source: org_study_id

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