Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice
NCT ID: NCT02555839
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
127 participants
OBSERVATIONAL
2015-02-20
2023-06-30
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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
4mg capsule on d1 through 21 of a 28 day cycle
Dexamethasone
40 mg (≤75 years) or 20mg (\>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
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
Pomalidomide
4mg capsule on d1 through 14 of a 21 day cycle
Dexamethasone
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
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,
Interventions
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Pomalidomide
4mg capsule on d1 through 21 of a 28 day cycle
Dexamethasone
40 mg (≤75 years) or 20mg (\>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
Pomalidomide
4mg capsule on d1 through 14 of a 21 day cycle
Dexamethasone
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
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,
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
2. Known hypersensitivity to Imnovid
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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LKH Feldkirch, Intern E, Hämatologie
Feldkirch, , Austria
Medical University Graz
Graz, , Austria
KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie
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
Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog
Vienna, , Austria
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
Vienna, , Austria
Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin
Vöcklabruck, , Austria
Countries
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Related Links
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Expanded Access for CC-4047
Other Identifiers
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CC-4047-MM-017
Identifier Type: -
Identifier Source: org_study_id
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