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

Sponsor

Celgene (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02555839

Collaborator

(none)

150

Enrollment

Locations

106.3

Anticipated Duration (Months)

11.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: Pomalidomide Drug: Dexamethasone Drug: Pomalidomide Drug: Dexamethasone Drug: Bortezomib

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 20, 2015

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
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	Drug: Pomalidomide 4mg capsule on d1 through 21 of a 28 day cycle Other Names: CC-4047 Imnovid Drug: Dexamethasone 40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle Other Names: Fortecortin
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	Drug: Pomalidomide 4mg capsule on d1 through 14 of a 21 day cycle Drug: 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 Drug: 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,

Arm

Intervention/Treatment

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

Drug: Pomalidomide

4mg capsule on d1 through 21 of a 28 day cycle

Other Names:

CC-4047

Imnovid

Drug: Dexamethasone

40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle

Other Names:

Fortecortin

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

Drug: Pomalidomide

4mg capsule on d1 through 14 of a 21 day cycle

Drug: 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

Drug: 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,

Outcome Measures

Primary Outcome Measures

Number of Adverse Events [Up to 2 years]
The number of participant adverse events

Secondary Outcome Measures

Response Rate [Up to 2 years]
The number of participants who achieve a response
Progression Free Survival [Up to 2 years]
The number of participants who survive without progression of disease
Duration of Response [Up to 2 years]
Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Pregnant or Lactating Females
Known hypersensitivity to Imnovid

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	LKH Feldkirch, Intern E, Hämatologie	Feldkirch	Austria	6800:
2	Medical University Graz	Graz	Austria	8036:
3	KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie	Linz	Austria	4020:
4	Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie	Linz	Austria	4020
5	Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I	Ried	Austria	4910
6	SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH	Salzburg	Austria	5020:
7	LKH Steyr, Innere Medizin II	Steyr	Austria	4400
8	AKH, Innere Medizin I, Klin. Abt. f. Hämatologie	Vienna	Austria	1090:
9	AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie	Vienna	Austria	1090:
10	St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie	Vienna	Austria	1130:
11	Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog	Vienna	Austria	1140:
12	Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie	Vienna	Austria	1160:
13	Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin	Vöcklabruck	Austria	4840