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.
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.
Study Type
OBSERVATIONAL
Enrollment
127
4mg capsule on d1 through 21 of a 28 day cycle
40 mg (≤75 years) or 20mg (\>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
4mg capsule on d1 through 14 of a 21 day cycle
LKH Feldkirch, Intern E, Hämatologie
Feldkirch, Austria
Medical University Graz
Graz, Austria
KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie
Number of Adverse Events
The number of participant adverse events
Time frame: Up to 2 years
Response Rate
The number of participants who achieve a response
Time frame: Up to 2 years
Progression Free Survival
The number of participants who survive without progression of disease
Time frame: Up to 2 years
Duration of Response
Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression
Time frame: Up to 2 years
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cycle 1-8: 20mg PO (≤75 years) or 10mg (\>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle; from cycle 9 onwards: Dexamethasone 20mg PO (≤75 years) or 10mg (\>75years) on Days 1, 2, 8, 9 of a 21 day cycle
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,
Linz, Austria
Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
Linz, Austria
Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I
Ried, Austria
SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH
Salzburg, Austria
LKH Steyr, Innere Medizin II
Steyr, Austria
AKH, Innere Medizin I, Klin. Abt. f. Hämatologie
Vienna, Austria
AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie
Vienna, Austria
St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie
Vienna, Austria
...and 3 more locations