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

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib

• Registration Number: NCT02555839
• Lead Sponsor: Celgene

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.

Study Timeline

• Study Start: 2015-02-20
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pomalidomide and Dexamethasone	Pomalidomide	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 and Dexamethasone	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, Bortezomib and Dexamethasone	Pomalidomide	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, Bortezomib and Dexamethasone	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, Bortezomib and Dexamethasone	Bortezomib	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

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Up to 2 years	The number of participant adverse events

Secondary Outcome Measures

Name	Time	Method
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
Response Rate	Up to 2 years	The number of participants who achieve a response

Trial Locations

Locations (13)

AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie; 🇦🇹 Vienna, Austria

LKH Feldkirch, Intern E, Hämatologie; 🇦🇹 Feldkirch, Austria

SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH; 🇦🇹 Salzburg, Austria

Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog; 🇦🇹 Vienna, Austria

Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I; 🇦🇹 Ried, Austria

Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie; 🇦🇹 Vienna, Austria

Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin; 🇦🇹 Vöcklabruck, Austria

Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie; 🇦🇹 Linz, Austria

LKH Steyr, Innere Medizin II; 🇦🇹 Steyr, Austria

Medical University Graz; 🇦🇹 Graz, Austria

KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie; 🇦🇹 Linz, Austria

St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie; 🇦🇹 Vienna, Austria

AKH, Innere Medizin I, Klin. Abt. f. Hämatologie; 🇦🇹 Vienna, Austria