Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice
Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
1 other identifier
observational
127
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2015
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 20, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedMarch 28, 2025
March 1, 2025
8.4 years
September 18, 2015
March 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Events
The number of participant adverse events
Up to 2 years
Secondary Outcomes (3)
Response Rate
Up to 2 years
Progression Free Survival
Up to 2 years
Duration of Response
Up to 2 years
Study Arms (2)
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
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
Interventions
4mg capsule on d1 through 21 of a 28 day cycle
40 mg (≤75 years) or 20mg (\>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
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,
Eligibility Criteria
Relapsed and/or Refractory Multiple Myeloma
You may qualify if:
- 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
You may not qualify if:
- Pregnant or Lactating Females
- Known hypersensitivity to Imnovid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (13)
LKH Feldkirch, Intern E, Hämatologie
Feldkirch, 6800:, Austria
Medical University Graz
Graz, 8036:, Austria
KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie
Linz, 4020:, Austria
Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
Linz, 4020, Austria
Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I
Ried, 4910, Austria
SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH
Salzburg, 5020:, Austria
LKH Steyr, Innere Medizin II
Steyr, 4400, Austria
AKH, Innere Medizin I, Klin. Abt. f. Hämatologie
Vienna, 1090:, Austria
AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie
Vienna, 1090:, Austria
St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie
Vienna, 1130:, Austria
Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog
Vienna, 1140:, Austria
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
Vienna, 1160:, Austria
Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin
Vöcklabruck, 4840, Austria
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2015
First Posted
September 22, 2015
Study Start
February 20, 2015
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
March 28, 2025
Record last verified: 2025-03