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

August 11, 2022 updated by: iOMEDICO AG

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

151

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Wuerttemberg
      • Freiburg, Baden-Wuerttemberg, Germany, 79106
        • iOMEDICO AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with relapsing or refractory multiple myeloma previously treated with at least two prior lines of therapy, including bortezomib and lenalidomide who have progressed under their last therapy regimen

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pomalidomide following lenalidomide
75 patients with pomalidomide directly following lenalidomide treatment
Pomalidomide following other therapy
75 patients with pomalidomide following any other prior therapy. This includes lenalidomide in earlier lines than the most recent line.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression free survival (PFS)
Time Frame: 6 years
6 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iOMEDICO AG

Investigators

  • Principal Investigator: Tobias Dechow, PhD, practice based oncology office Ravensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2014

Primary Completion (Actual)

February 4, 2021

Study Completion (Actual)

February 4, 2021

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

March 3, 2014

Study Record Updates

Last Update Posted (Actual)

August 12, 2022

Last Update Submitted That Met QC Criteria

August 11, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IOM-10280

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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