Pomalidomide
Drug4mg capsule on d1 through 21 of a 28 day cycle
Other names: CC-4047, Imnovid
NCT Number: NCT02555839
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.
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Notify Me18 year and older
All sexes
Observational
LKH Feldkirch, Intern E, Hämatologie, Feldkirch, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
≥2 antimyeloma treatments (including lenalidomide and bortezomib), induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment
≥1 antimyeloma treatments (including lenalidomide) induction therapy followed by ASCT and consolidation or maintenance therapy is considered as 1 antimyeloma treatment
Exclusion criteria
4mg capsule on d1 through 21 of a 28 day cycle
Other names: CC-4047, Imnovid
40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
Other names: Fortecortin
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,
Time frame: Up to 2 years
The number of participant adverse events
Time frame: Up to 2 years
The number of participants who achieve a response
Time frame: Up to 2 years
The number of participants who survive without progression of disease
Time frame: Up to 2 years
Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression
Celgene
Industry
Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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