Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice

Multiple Myeloma Clinical Trial

Official title:

Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02555839
• Other study ID #: CC-4047-MM-017
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

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

External Links

•   Expanded Access for CC-4047