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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02555839
Other study ID # CC-4047-MM-017
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 20, 2015
Est. completion date December 31, 2023

Study information

Verified date November 2023
Source Celgene
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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: 1. Pregnant or Lactating Females 2. Known hypersensitivity to Imnovid

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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,

Locations

Country Name City State
Austria LKH Feldkirch, Intern E, Hämatologie Feldkirch
Austria Medical University Graz Graz
Austria Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie Linz
Austria KH der Elisabethinen Linz , 1. Interne Hämato-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 Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog Vienna
Austria St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie Vienna
Austria Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie Vienna
Austria Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin Vöcklabruck

Sponsors (1)

Lead Sponsor Collaborator
Celgene

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Adverse Events The number of participant adverse events Up to 2 years
Secondary Response Rate The number of participants who achieve a response Up to 2 years
Secondary Progression Free Survival The number of participants who survive without progression of disease Up to 2 years
Secondary 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
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