Clinical trial NCT02555839: Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice
Official title: Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Pomalidomide
Imnovid
Non-interventional
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2015-09-22
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Relapsed and/or Refractory Multiple Myeloma

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse Events
timeFrame: Up to 2 years
Secondary outcomes:
measure: Response Rate
timeFrame: Up to 2 years
measure: Progression Free Survival
timeFrame: Up to 2 years
measure: Duration of Response
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch, Intern E, Hämatologie
city: Graz
country: Austria
facility: Medical University Graz
city: Linz
country: Austria
facility: KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie
city: Linz
country: Austria
facility: Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
city: Ried
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I
city: Salzburg
country: Austria
facility: SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH
city: Steyr
country: Austria
facility: LKH Steyr, Innere Medizin II
city: Vienna
country: Austria
facility: AKH, Innere Medizin I, Klin. Abt. f. Hämatologie
city: Vienna
country: Austria
facility: AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie
city: Vienna
country: Austria
facility: St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie
city: Vienna
country: Austria
facility: Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog
city: Vienna
country: Austria
facility: Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
city: Vöcklabruck
country: Austria
facility: Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: