NCT02075996

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 11, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

7 years

First QC Date

February 27, 2014

Last Update Submit

August 11, 2022

Conditions

Multiple Myeloma

Keywords

pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,

Outcome Measures

Primary Outcomes (1)

  • Progression free survival (PFS)

    6 years

Secondary Outcomes (9)

  • Overall Response Rate (ORR)

    6 years

  • Time to Treatment Discontinuation (TTD)

    6 years

  • Time to next treatment (TNT)

    6 years

  • adverse reaction profile

    3 years

  • secondary malignancies

    6 years

  • +4 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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®

You may not qualify if:

  • 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®

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

iOMEDICO AG

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Related Publications (1)

  • 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.

    PMID: 34714555DERIVED

MeSH Terms

Conditions

Multiple MyelomaNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tobias Dechow, PhD

    practice based oncology office Ravensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2014

First Posted

March 3, 2014

Study Start

February 11, 2014

Primary Completion

February 4, 2021

Study Completion

February 4, 2021

Last Updated

August 12, 2022

Record last verified: 2022-08

Locations

DE(1)