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OpenTrials
Completed

NCT Number: NCT02075996

Non-interventional Study With Pomalidomide (Imnovid®)

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: 6 years

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 6 years

  2. Time to Treatment Discontinuation (TTD)

    Time frame: 6 years

  3. Time to next treatment (TNT)

    Time frame: 6 years

  4. adverse reaction profile

    Time frame: 3 years

  5. secondary malignancies

    Time frame: 6 years

    long term safety is focused on secondary malignancies

  6. overall Survival (OS)

    Time frame: 6 years

  7. relative dose intensity of pomalidomide and dexamethasone

    Time frame: 3 years

  8. assess changes in myeloma-related quality of life

    Time frame: 3 years

  9. 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)

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Registry information

Official study title

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

Acronym: Poseidon

Important dates

Study start
2014
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2014
Registry last updated
Aug 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.