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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pomalidomide and Dexamethasone | Pomalidomide 4mg capsules by mouth (PO) on days 1 through 21 of a 28 day cycle and Dexamethasone 40mg PO (≤75 years) or 20mg (>75years) on Days 1, 8, 15, 22 of a 28 day cycle until progression or unacceptable toxicity |
| |
| Pomalidomide, Bortezomib and Dexamethasone | Cycle 1-8: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle until progression or unacceptable toxicity; from cycle 9 onwards: Pomalidomide 4mg capsules by mouth (PO) on days 1 through 14 of a 21 day cycle, Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle, and Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle until progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug | 4mg capsule on d1 through 21 of a 28 day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | The number of participant adverse events | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Response Rate | The number of participants who achieve a response | Up to 2 years |
| Progression Free Survival | The number of participants who survive without progression of disease |
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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:
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Relapsed and/or Refractory Multiple Myeloma
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LKH Feldkirch, Intern E, Hämatologie | Feldkirch | 6800: | Austria | |||
| Medical University Graz |
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| Label | URL |
|---|---|
| Expanded Access for CC-4047 | View source |
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| Dexamethasone | Drug | 40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle |
|
|
| Pomalidomide | Drug | 4mg capsule on d1 through 14 of a 21 day cycle |
|
| Dexamethasone | Drug | 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 |
|
| Bortezomib | Drug | 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, |
|
| 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 | Up to 2 years |
| Graz |
| 8036: |
| Austria |
| KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie | Linz | 4020: | Austria |
| Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie | Linz | 4020 | Austria |
| Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I | Ried | 4910 | Austria |
| SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH | Salzburg | 5020: | Austria |
| LKH Steyr, Innere Medizin II | Steyr | 4400 | Austria |
| AKH, Innere Medizin I, Klin. Abt. f. Hämatologie | Vienna | 1090: | Austria |
| AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie | Vienna | 1090: | Austria |
| St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie | Vienna | 1130: | Austria |
| Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog | Vienna | 1140: | Austria |
| Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie | Vienna | 1160: | Austria |
| Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin | Vöcklabruck | 4840 | Austria |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| C018038 | dexamethasone acetate |
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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