Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice
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|ClinicalTrials.gov Identifier: NCT02555839|
Recruitment Status : Recruiting
First Posted : September 22, 2015
Last Update Posted : March 2, 2018
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.
|Condition or disease||Intervention/treatment|
|Multiple Myeloma||Drug: Pomalidomide Drug: Dexamethasone|
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|
|Estimated Enrollment :||70 participants|
|Official Title:||Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)|
|Actual Study Start Date :||March 1, 2015|
|Estimated Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Pomalidomide and Dexamethasone
Pomalidomide 4mg capsules by mouth (PO) on days 1 though 21 of a 28 day cycle and Dexamethasone 40mg PO on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicty
4mg capsules on Days 1 through 21 of a 28 day cycle
Other Names:Drug: Dexamethasone
40mg by mouth on Days 1, 8, 15, 22 of a 28 day cycle
Other Name: Fortecortin
- Number of Adverse Events [ Time Frame: Up to 2 years ]The number of participant adverse events
- Response Rate [ Time Frame: Up to 2 years ]The number of participants who achieve a response
- Progression Free Survival [ Time Frame: Up to 2 years ]The number of participants who survive without progression of disease
- Duration of Response [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555839
|Contact: Associate Director Clinical Trial Disclosurefirstname.lastname@example.org|
|LKH Feldkirch, Intern E, Hämatologie||Recruiting|
|Feldkirch, Austria, 6800:|
|Medical University Graz||Recruiting|
|Graz, Austria, 8036:|
|KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie||Recruiting|
|Linz, Austria, 4020:|
|SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH||Recruiting|
|Salzburg, Austria, 5020:|
|LKH Steyr, Innere Medizin II||Recruiting|
|Steyr, Austria, 4400|
|AKH, Innere Medizin I, Klin. Abt. f. Hämatologie||Recruiting|
|Vienna, Austria, 1090:|
|AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie||Recruiting|
|Vienna, Austria, 1090:|
|St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie||Recruiting|
|Vienna, Austria, 1130:|
|Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog||Not yet recruiting|
|Vienna, Austria, 1140:|
|Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie||Not yet recruiting|
|Vienna, Austria, 1160:|
|Study Chair:||Guenter Voraberger, MD||Celgene|