Multiple Myeloma
Conditions
Keywords
pomalidomide, Imnovid, dexamethasone, Poseidon, multiple myeloma, daily routine, secondary malignancies, Germany, non-interventional study, safety,
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
Interventions
None listed
Sponsors
iOMEDICO AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | 6 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Treatment Discontinuation (TTD) | 6 years | — |
| Time to next treatment (TNT) | 6 years | — |
| adverse reaction profile | 3 years | — |
| secondary malignancies | 6 years | long term safety is focused on secondary malignancies |
| Overall Response Rate (ORR) | 6 years | — |
| relative dose intensity of pomalidomide and dexamethasone | 3 years | — |
| assess changes in myeloma-related quality of life | 3 years | — |
| explore additional supportive therapies | 3 years | To explore additional supportive therapies used on this patient population (e.g. G-CSF, antibiotics, DVT prophylaxis) |
| overall Survival (OS) | 6 years | — |
Countries
Germany
Outcome results
None listed