Multiple MyelomaPoseidonNCT02075996
Non-interventional Study With Pomalidomide (Imnovid®)
An observational study of Multiple Myeloma, run by iOMEDICO AG at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 151 participants
- Where
- 1 siteGermany
- Study dates
- 11 Feb 2014to 4 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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®
Who cannot join
- 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®
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Multiple Myeloma
- Keywords
- pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,
- Medical subject headings
- Multiple Myeloma, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
Measured: 6 years
Secondary outcomes (9)
Overall Response Rate (ORR)
Measured: 6 years
Time to Treatment Discontinuation (TTD)
Measured: 6 years
Time to next treatment (TNT)
Measured: 6 years
adverse reaction profile
Measured: 3 years
secondary malignancies
long term safety is focused on secondary malignancies
Measured: 6 years
overall Survival (OS)
Measured: 6 years
relative dose intensity of pomalidomide and dexamethasone
Measured: 3 years
assess changes in myeloma-related quality of life
Measured: 3 years
explore additional supportive therapies
To explore additional supportive therapies used on this patient population (e.g. G-CSF, antibiotics, DVT prophylaxis)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study start11 Feb 2014
- Primary completion4 Feb 2021
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- iOMEDICO AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Dechow, PhD, Principal investigator, practice based oncology office Ravensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075996
- Sponsor's protocol ID
- IOM-10280
- Acronym
- Poseidon
- Status last verified
- Aug 2022
- First submitted
- 27 Feb 2014
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34714555
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study of Pomalidomide (Imnovid®) in Combination With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT02075996
- Acronym / sponsor ID
- Poseidon / IOM-10280
- Conditions
- Multiple Myeloma
- Keywords
- pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- iOMEDICO AGIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2014 (actual)
- Primary completion
- 4 Feb 2021 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 3 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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®
Key exclusion criteria (4 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression free survival (PFS)
Time frame: 6 years
9 secondary outcomes
Overall Response Rate (ORR)
Time frame: 6 years
Time to Treatment Discontinuation (TTD)
Time frame: 6 years
Time to next treatment (TNT)
Time frame: 6 years
adverse reaction profile
Time frame: 3 years
secondary malignancies
Time frame: 6 years
overall Survival (OS)
Time frame: 6 years
relative dose intensity of pomalidomide and dexamethasone
Time frame: 3 years
assess changes in myeloma-related quality of life
Time frame: 3 years
explore additional supportive therapies
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Derived from this study: PubMed 34714555Dechow 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Dechow, PhD principal investigator
practice based oncology office Ravensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by iOMEDICO AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (PFS) (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02075996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2022.