Multiple Myeloma
Conditions
Keywords
Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Pomalidomide, Imnovid, Non-interventional
Brief summary
There is a high unmet medical need for an anti-myeloma therapy for RRMM patients previously treated with Lenalidomide and Bortezomib, due to poor prognosis. This observational study focuses on the collection of data concerning the safe and optimal usage of Pomalidomide, a new therapy option for RRMM patients, thereby increasing the knowledge about optimal AE management. Beside this, further analysis of tolerability, dosage and efficacy will be performed. This knowledge could lead to a optimization of Pomalidomide usage and treatment.
Detailed description
There is a high unmet medical need for further anti-myeloma therapy in patients with RRMM who have previously been treated with Lenalidomide and Bortezomib containing regimens that is both active and tolerable, as these patients have a poor prognosis. Hands-on experience with Pomalidomide is very limited in Austria and a non-interventional study enhances the attention paid to safe use and handling of the product as well as increase knowledge about optimal adverse event (AE) management substantially. A detailed record of the medical history including. co-morbidities and pre-treatment regimens will allow analysis of the impact there of on tolerability, dosage and efficacy. Beside the collection of data on efficacy and tolerability this observational drug utilization study could give insight into the clinical practice and the routine use of Pomalidomide.
Interventions
DRUGPomalidomide
4mg capsule on d1 through 21 of a 28 day cycle
DRUGDexamethasone
40 mg (≤75 years) or 20mg (\>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
DRUGBortezomib
cycle 1-8: Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle; from cycle 9 onwards: Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle,
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed IC * age ≥ 18 years * relapsed/refractory MM * cohort A (combination pomalidomide und dexamethasone): ≥2 antimyeloma treatments (including lenalidomide and bortezomib), induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment * cohort B (combination pomalidomide, bortezomib and dexamethasone): ≥1 antimyeloma treatments (including lenalidomide) induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment * refractory to last antimyeloma treatment * adequate contraception according to RMP * adequate thrombosis prophylaxis
Exclusion criteria
1. Pregnant or Lactating Females 2. Known hypersensitivity to Imnovid
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | Up to 2 years | The number of participant adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Up to 2 years | The number of participants who achieve a response |
| Progression Free Survival | Up to 2 years | The number of participants who survive without progression of disease |
| Duration of Response | Up to 2 years | Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression |
Countries
Austria
Outcome results
None listed