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

Sponsor
iOMEDICO AG (Industry)
Overall Status
Completed
CT.gov ID
NCT02075996
Collaborator
(none)
151
Enrollment
1
Location
83.8
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    151 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Non-interventional Study of Pomalidomide (Imnovid®) in Combination With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
    Actual Study Start Date :
    Feb 11, 2014
    Actual Primary Completion Date :
    Feb 4, 2021
    Actual Study Completion Date :
    Feb 4, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Progression free survival (PFS) [6 years]

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [6 years]

    2. Time to Treatment Discontinuation (TTD) [6 years]

    3. Time to next treatment (TNT) [6 years]

    4. adverse reaction profile [3 years]

    5. secondary malignancies [6 years]

      long term safety is focused on secondary malignancies

    6. overall Survival (OS) [6 years]

    7. relative dose intensity of pomalidomide and dexamethasone [3 years]

    8. assess changes in myeloma-related quality of life [3 years]

    9. explore additional supportive therapies [3 years]

      To explore additional supportive therapies used on this patient population (e.g. G-CSF, antibiotics, DVT prophylaxis)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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®

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 iOMEDICO AG Freiburg Baden-Wuerttemberg Germany 79106

    Sponsors and Collaborators

    • iOMEDICO AG

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    iOMEDICO AG
    ClinicalTrials.gov Identifier:
    NCT02075996
    Other Study ID Numbers:
    • IOM-10280
    First Posted:
    Mar 3, 2014
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    Keywords provided by iOMEDICO AG
    pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,
    Additional relevant MeSH terms:
    Multiple Myeloma
    Neoplasms, Plasma Cell

    Study Results

    No Results Posted as of Aug 12, 2022