Multiple MyelomaNCT02555839
Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) With Pomalidomide in Clinical Practice
An observational study of Multiple Myeloma, run by Celgene at 13 sites in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Pomalidomide, Dexamethasone and Bortezomib
- Type of treatment
- Pill or oral medicine
- How many people
- 127 participants
- Where
- 13 sitesAustria
- Study dates
- 20 Feb 2015to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Relapsed and/or Refractory Multiple Myeloma
Who may be able to join
- 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):
Show all 10Show fewer
- ≥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
Who cannot join
- Pregnant or Lactating Females
- Known hypersensitivity to Imnovid
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Austria13 sites
LKH Feldkirch, Intern E, Hämatologie
Feldkirch, 6800:
Medical University Graz
Graz, 8036:
KH der Elisabethinen Linz , 1. Interne Hämato-Onkologie
Linz, 4020:
Kepleruniversitätsklinikum GmbH, Hämatologie und Internistische Onkologie
Linz, 4020
Krankenhaus der Barmherzigen Schwestern Ried, Innere Medizin I
Ried, 4910
SCRI-CCCIT gemeinnützige GmbH & Universitätsklinikum der PMU Salzburg Gemeinnützige Salzburger Landeskliniken BetriebsgmbH
Salzburg, 5020:
LKH Steyr, Innere Medizin II
Steyr, 4400
AKH, Innere Medizin I, Klin. Abt. f. Hämatologie
Vienna, 1090:
AKH, Universitätsklinik für Innere Medizin I /Klin. Abteilung für Onkologie
Vienna, 1090:
St. Josef Krankenhaus Wien,1. Abteilung für Innere Medizin Zentrum für Onkologie
Vienna, 1130:
Hanusch Krankenhaus Wien 3. Medizinische Abteilung Hämatolog
Vienna, 1140:
Wilhelminenspital, 1. Med.Abteilung, Zentrum für Onkologie
Vienna, 1160:
Salzkammergut-Klinikum Vöcklabruck, Abteilung Innere Medizin
Vöcklabruck, 4840
About this study
Official title: Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Pomalidomide, Dexamethasone, Bortezomib
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Pomalidomide, Imnovid, Non-interventional
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called CC-4047, Imnovid
4mg capsule on d1 through 21 of a 28 day cycle
DexamethasoneDrug
Also called Fortecortin
40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
PomalidomideDrug
4mg capsule on d1 through 14 of a 21 day cycle
DexamethasoneDrug
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
BortezomibDrug
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,
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Pomalidomide; Drug: Dexamethasone | |
| 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 Receives: Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
The number of participant adverse events
Measured: Up to 2 years
Secondary outcomes (3)
Response Rate
The number of participants who achieve a response
Measured: Up to 2 years
Progression Free Survival
The number of participants who survive without progression of disease
Measured: Up to 2 years
Duration of Response
Duration of response is defined as time from the initial documented response (partial response or better) to confirmed disease progression
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start20 Feb 2015
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by CelgeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02555839
- Sponsor's protocol ID
- CC-4047-MM-017
- Status last verified
- Mar 2025
- First submitted
- 18 Sep 2015
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM)
- ClinicalTrials.gov ID
- NCT02555839
- Acronym / sponsor ID
- CC-4047-MM-017
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma, Pomalidomide, Imnovid, Non-interventional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 20 Feb 2015 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 22 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pomalidomide and Dexamethasone | – | Drug: Pomalidomide, Drug: DexamethasonePomalidomide 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 | – | Drug: Pomalidomide, Drug: Dexamethasone, Drug: BortezomibCycle 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Relapsed and/or Refractory Multiple Myeloma
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant or Lactating Females
- Known hypersensitivity to Imnovid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PomalidomideAlso: CC-4047, Imnovid4mg capsule on d1 through 21 of a 28 day cycle | Drug | Pomalidomide and Dexamethasone |
| DexamethasoneAlso: Fortecortin40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle | Drug | Pomalidomide and Dexamethasone |
| Pomalidomide4mg capsule on d1 through 14 of a 21 day cycle | Drug | Pomalidomide, Bortezomib and Dexamethasone |
| Dexamethasonecycle 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 | Pomalidomide, Bortezomib and Dexamethasone |
| Bortezomibcycle 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, | Drug | Pomalidomide, Bortezomib and Dexamethasone |
Primary outcome
Number of Adverse Events
Time frame: Up to 2 years
The number of participant adverse events
3 secondary outcomes
Response Rate
Time frame: Up to 2 years
Progression Free Survival
Time frame: Up to 2 years
Duration of Response
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Expanded Access for CC-4047Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Celgene at 13 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.