Myelodysplastic SyndromeMORENCT01347944
MORE - Monitoring Revlimid - Collecting of Patient Information From Myelodysplastic Syndrome (MDS) Italian National Registry
An observational study of Myelodysplastic Syndrome, run by Celgene at 45 sites in Italy.
Trial summary
The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- lenalidomide
- How many people
- 149 participants
- Where
- 45 sitesItaly
- Study dates
- 1 Jan 2011to 30 Jun 2013
- 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: Patients affected by intermediate-1 and low risk MDS associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present.
Who may be able to join
- intermediate 1 and low risk MDS patients associated with:
- transfusion dependency anemia (at least 2 units per 8 weeks before starting of Revlimid treatment )
- 5q31-33 deletion isolated or associated to other chromosomal abnormalities.
Who cannot join
- patients with serum creatinine > 2.5mg/dl
- child bearing potential females who do not use adequate contraceptive methods
Trial locations and contacts
45 sites in 1 country.
45 sites in 1 country
Italy45 sites
Dipartimento Onco - Ematologico Azienda Ospedaliera SS Antonio, Biagio e Cesare Arrigo
Alessandria, 15121
Unità Operativa Clinica di Ematologia Azianda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, 60100
Dipartimento di Oncologia Medica Ospedale Cardinale G. Massaia
Asti, 14100
Ematologia Azienda Ospedaliera Universitaria Policlinico di Bari
Bari, 70124
Dipartimento di Ematologia Ospedale dell'U.L.S.S. n.1 Belluno
Belluno, 32100
Ematologia A.O. Ospedale Riuniti di Bergamo
Bergamo, 24128
Dip. Medicina Interna Ospedale degli Infermi di Biella
Biella, 13900
Dipartimento di Ematologia Spedale Civili di Brescia
Brescia, 25123
Dipartimento Trapianto di Midollo Allogenico Spedale Civili di Brescia
Brescia, 25123
Dipartimento di Ematologia Ospedale R. Binaghi
Cagliari, 09126
Dip. Di Oncoematologia A.O. S.Anna e S. Sebastiano
Caserta, 81100
Dip. Di Ematologia A.O. Istituti Ospedalieri
Cremona, 26100
Dip. Di Ematologia Az. Ospedaliero-Universitaria Careggi
Florence, 50139
Dip. Di Ematologia A.O. Universitaria S. Martino
Genova, 10-1632
Dip. Di Medicina Interna A.O. Universitaria S. Martino
Genova, 10-1632
Dip. Di Ematologia Azienda Ospedaliera V. Fazzi
Lecce, 73100
Centro Trapianti di Midollo Ospedale Maggiore Policlinico
Milan, 20122
Dip. Di Ematologia Policlinico, Az. Ospedaliero- Universitaria
Modena, 41124
Dip. Di Ematologia Azienda Ospedaliera S. Gerardo
Monza, 20052
Dip. Di Oncoematologia A.O. Universitaria Federico II
Naples, 80131
Dip. Di Ematologia Presidio Ospedaliero Umberto I
Nocera Inferiore, 84014
Dip. Di Ematologia Ospedale S. Francesco
Nuoro, 08100
Dip. Di Ematologia Azienda Ospedaliera
Padova, 35127
Dip. di Ematologia Azienda Ospedaliera
Parma, 43100
Dip. Di Ematologia Azienda Ospedaliera - Osp. S. Maria della Misericordia
Perugia, 06156
Dip. Di Ematologia Azienda Ospedaliera s. Salvatore
Pesaro, 61100
Dip. Di Ematologia Az. Ospedaliera Regionale S. Carlo
Potenza, 85100
Servizio di Ematologia - Dip. di Oncologia Az. Ospedaliera di Reggio Emilia - Arcispedale S. Maria Nuova
Reggio Emilia, 42100
Dip. Di Ematologia Ospedale S. Maria delle Croci
Revenna, 48100
U. O. Ematologia Az. Ospedaliero-Universitaria Policlinico Tor Vergata
Roma, 00133
U.O.C Ematologia Ospedale S. Eugenio, Piazzale dell'Umanesimo
Roma, 00144
Dip. di Ematologia Policlinico Umberto I
Roma, 00161
U.O.C. Ematologia Policlinico Universitario Gemelli
Roma, 00168
Dip. di Oncoematologia Ospedale Civile Giannettasio
Rossano, 87068
Dip. di Oncoematologia Az. ULSS 18
Rovigo, 45100
Struttura di Ematologia, Dip. di Oncoematologia IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Dip. di Ematologia Policlinico Universitario di Sassari
Sassari, 07100
Divisione di Ematologia e Trapianti Spedali Riuniti
Siena, 53100
Dip. di Ematologia 1 A.O. Universitaria S.Giovanni Battista
Torino, 10126
Dip. di Ematologia 2 A.O. Universitaria S.Giovanni Battista
Torino, 10126
Dip. di Ematologia e Terapie Cellulari Ospedale Mauriziano Umberto I
Torino, 10128
Unità Operativa Trasfusionale ed Immunologia Centro di riferimento per le malattie rare e centro regionale per le malattie del sangue Ospedale S. Giacomo Apostolo
Treviso, 31033
Ospedale Dell'Angelo USL12 - Venezia (Mestre)
Venezia, 30174
Dip. Funzionale di Terapie Cellulari e Ematologia Azienda Sanitaria ULSS 6 - Osp. di Vicenza
Vicenza, 36100
Dip. Di Ematologia Ospedale di Belcolle
Viterbo, 01100
About this study
Official title: Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With Myelodysplastic Syndromes
The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.
Read the detailed description
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- lenalidomide
- Keywords
- MORE, Monitoring Revlimid, Myelodysplastic Syndrome, Transfusion-dependent anemia, 5q deletion, lenalidomide
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenalidomideDrug
Also called Revlimid®
Patients who were prescribed Revlimid from 31October 2008 to present.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects achieving red blood cell (RBC) transfusion independence
Measured: 14 months
Number of subjects achieving an erythroid response
Measured: 14 months
Number of subjects achieving a cytogenetic response
Measured: 14 months
Secondary outcomes (6)
Number of participants with adverse events
Measured: 14 months
Duration of RBC transfusion independence
Measured: 14 months
Duration of cytogenetic response
Measured: 14 months
Time to RBC transfusion independence
Measured: 14 months
Progression to acute myeloid leukemia (AML)
Measured: 14 months
Number of participants alive
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2011 (estimated)
- Study start1 Jan 2011
- Primary completion30 Jun 2013
- Study completion30 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myelodysplastic SyndromeStudies 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
- Other
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sante Cundari, PhD, MSc, Study director, Celgene s.r.l.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347944
- Sponsor's protocol ID
- NIPMS- Celgene-MDS-ITA-002
- Acronym
- MORE
- Status last verified
- Nov 2019
- First submitted
- 29 Oct 2010
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arcioni F, Roncadori A, Di Battista V, Tura S, Covezzoli A, Cundari S, Mecucci C; MORE Study Centres. Lenalidomide treatment of myelodysplastic syndromes with chromosome 5q deletion: Results from the National Registry of the Italian Drug Agency. Eur J Haematol. 2018 Jul;101(1):78-85. doi: 10.1111/ejh.13067. Epub 2018 May 22.
PubMed 29569278
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Non-interventional, Multicenter Study Aimed at Collecting Retrospective/Prospective 648/96 Italian Registry Data Related to Lenalidomide (Revlimid®) Prescription to Patients With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT01347944
- Acronym / sponsor ID
- MORE / NIPMS- Celgene-MDS-ITA-002
- Conditions
- Myelodysplastic Syndrome
- Keywords
- MORE, Monitoring Revlimid, Myelodysplastic Syndrome, Transfusion-dependent anemia, 5q deletion, lenalidomide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Jun 2013 (actual)
- Study completion
- 30 Jun 2013 (actual)
- First posted
- 5 May 2011 (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.
The purpose of this study is to collect clinical and laboratory data for patients affected by intermediate 1 and low risk Myelodysplastic Syndrome (MDS) associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present. Revlimid is available in Italy for these patients since October 2008 based on a local disposition of the Italian Drug Agency (AIFA) issued according to a National law named 648/96.
Detailed description
There will be retrospective collection and integration of clinical laboratory data as well as prospective data collection on the same patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by intermediate-1 and low risk MDS associated by deletion 5q who were prescribed Revlimid from 31October 2008 to present.
Key inclusion criteria (3 listed)
- intermediate 1 and low risk MDS patients associated with:
Key exclusion criteria (2 listed)
- patients with serum creatinine > 2.5mg/dl
- child bearing potential females who do not use adequate contraceptive methods
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 |
|---|---|---|
| lenalidomideAlso: Revlimid®Patients who were prescribed Revlimid from 31October 2008 to present. | Drug | – |
Primary outcome
Number of subjects achieving red blood cell (RBC) transfusion independence
Time frame: 14 months
Number of subjects achieving an erythroid response
Time frame: 14 months
Number of subjects achieving a cytogenetic response
Time frame: 14 months
6 secondary outcomes
Number of participants with adverse events
Time frame: 14 months
Duration of RBC transfusion independence
Time frame: 14 months
Duration of cytogenetic response
Time frame: 14 months
Time to RBC transfusion independence
Time frame: 14 months
Progression to acute myeloid leukemia (AML)
Time frame: 14 months
Number of participants alive
Time frame: 14 months
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 18 Nov 2019.
- Background: PubMed 29569278Arcioni F, Roncadori A, Di Battista V, Tura S, Covezzoli A, Cundari S, Mecucci C; MORE Study Centres. Lenalidomide treatment of myelodysplastic syndromes with chromosome 5q deletion: Results from the National Registry of the Italian Drug Agency. Eur J Haematol. 2018 Jul;101(1):78-85. doi: 10.1111/ejh.13067. Epub 2018 May 22.
Related trials for Myelodysplastic Syndrome
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 1/2
Omacetaxine + Azacitidine in Untreated Patients With High Grade MDS
High Grade Myelodysplastic Syndromes
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Sante Cundari, PhD, MSc study director
Celgene s.r.l.
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndrome, run by Celgene at 45 sites in Italy.
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 3 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Italy. 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 subjects achieving red blood cell (RBC) transfusion independence (time frame: 14 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01347944, which also lists 1 linked publication.
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 18 Nov 2019.