Clinical trial NCT02075996: Non-interventional Study With Pomalidomide (Imnovid®)
Official title: Non-interventional Study of Pomalidomide (Imnovid®) in Combination With Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2014-03-03
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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®

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 6 years
Secondary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 6 years
measure: Time to Treatment Discontinuation (TTD)
timeFrame: 6 years
measure: Time to next treatment (TNT)
timeFrame: 6 years
measure: adverse reaction profile
timeFrame: 3 years
measure: secondary malignancies
timeFrame: 6 years
measure: overall Survival (OS)
timeFrame: 6 years
measure: relative dose intensity of pomalidomide and dexamethasone
timeFrame: 3 years
measure: assess changes in myeloma-related quality of life
timeFrame: 3 years
measure: explore additional supportive therapies
timeFrame: 3 years
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: iOMEDICO AG
state: Baden-Wuerttemberg
Study officials:
affiliation: practice based oncology office Ravensburg
name: Tobias Dechow, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.