Multiple MyelomaRETRONCT03602755
A Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma in Spain
An observational study of Multiple Myeloma, run by Celgene at 20 sites in Spain.
Trial summary
This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 706 participants
- Where
- 20 sitesSpain
- Study dates
- 19 Jul 2018to 18 Jan 2019
- 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: In total, 400 patients with a de novo diagnosis of multiple myeloma who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive, in a routine clinical practice setting in Spain, will be included.
Who may be able to join
- Patients aged ≥ 18 years
- Patients with newly diagnosed MM who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive.
- Patients who give informed consent before data collection begins.
Who cannot join
- Patients who participated in a clinical trial for first-line treatment of MM during the study period.
- Patients who are alive, but do not give their IC.
- Patients with MM who did not receive treatment.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
H. del Mar
Barcelona, 0 8003
H. Cabueñes
Gijón, Principality of Asturias, 33394
H. Josep Trueta
Girona, 17007
H. Jerez
Jerez de la Frontera, Cadiz, 11408
ICO Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
H. Arnau de Villanova
Lleida, 25198
H- Virgen de la Victoria
Málaga, 29010
H. Carlos Haya
Málaga, 29010
H. Althaia
Manresa, Barcelona, 08243
H. Ourense (CHOU)
Ourense, 32005
H. Central de Asturias
Oviedo, Principality of Asturias, 33011
H. Son Espases
Palma, Balearic Islands, 07120
H. Santiago (CHUS)
Santiago de Compostela, A Coruña, 15706
H. Virgen Macarena
Seville, 41009
H. Joan XXIII
Tarragona, 43005
H. Mutua de Terrassa
Terrassa, Barcelona, 08221
H. Dr. Peset
Valencia, 46017
H. La Fe
Valencia, 46026
H. Alvaro Cunqueiro
Vigo, Pontevedra, 36312
H. Txagorritxu
Vitoria-Gasteiz, Alava, 01009
About this study
Official title: Retrospective Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma Between 2012 and 2016, Treated According to Routine Clinical Practice in Spain
This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding any influence on the physician's clinical practice.
- Conditions
- Multiple Myeloma
- Keywords
- Transplant, Multiple Myeloma, Spain
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with newly diagnosed transplant-ineligible MM | Adult Patients with newly diagnosed MM who were not suitable candidates for ASCT who started first-line treatment for the study disease in a routine clinical practice setting between 2012 and 2016, inclusive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the first-line treatment regimens
Number of patients in the different first-line treatment regimens, in terms of the main drug used in patients diagnosed de novo with MM who were not candidates for autologous stem cell transplantation (ASCT)
Measured: Up to approximately 5 months
Secondary outcomes (9)
Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain
Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each staging group: Stage I, II and III (ISS) and ISS R
Measured: Up to approximately 5 months
Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain
Number of patients with a diagnosis of MM who were not candidates for ASCT in Spain in each MM subtype group
Measured: Up to approximately 5 months
Progression-free survival (PFS)
Is described as time from start of treatment until disease progression or death
Measured: Up to approximately 5 months
Overall survival (OS)
Is described as time from start of the treatment until death
Measured: Up to approximately 5 months
Overall response rate
Is based on IMWG criteria
Measured: Up to approximately 5 months
Duration of response
Is described as time from start of the treatment until end of first line treatment
Measured: Up to approximately 5 months
Patients who receive second-line treatment
Proportion of patients who receive second-line treatment
Measured: Up to approximately 5 months
Patients who underwent dose adjustment or switched treatment
Proportion of patients who underwent dose adjustment or switched treatment
Measured: Up to approximately 5 months
Patients who discontinued treatment
Proportion of patients who discontinued treatment
Measured: Up to approximately 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start19 Jul 2018
- Primary completion18 Jan 2019
- Study completion18 Jan 2019
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 706 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giselle Lostaunau, MD, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03602755
- Sponsor's protocol ID
- NDS-MM-002
- Other IDs
- U1111-1215-4398
- Acronym
- RETRO
- Status last verified
- Jan 2019
- First submitted
- 26 Jun 2018
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the First-line Treatment of Patients With Newly Diagnosed Transplant-ineligible Multiple Myeloma Between 2012 and 2016, Treated According to Routine Clinical Practice in Spain
- ClinicalTrials.gov ID
- NCT03602755
- Acronym / sponsor ID
- RETRO / NDS-MM-002
- Conditions
- Multiple Myeloma
- Keywords
- Transplant, Multiple Myeloma, Spain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 706 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2018 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 18 Jan 2019 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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.
This is an observational, post-authorization, retrospective, multicenter study (PAS-OD) that will be conducted in approximately 20 centers in Spain. In all cases, only data recorded prior to the date of study start will be collected to ensure its retrospective nature, thus reflecting real clinical practice, avoiding any influence on the physician's clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with newly diagnosed transplant-ineligible MM | – | –Adult Patients with newly diagnosed MM who were not suitable candidates for ASCT who started first-line treatment for the study disease in a routine clinical practice setting between 2012 and 2016, inclusive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In total, 400 patients with a de novo diagnosis of multiple myeloma who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive, in a routine clinical practice setting in Spain, will be included.
Key inclusion criteria (3 listed)
- Patients aged ≥ 18 years
- Patients with newly diagnosed MM who were not suitable candidates for ASCT who started anti-myeloma treatment between 2012 and 2016, inclusive.
- Patients who give informed consent before data collection begins.
Key exclusion criteria (3 listed)
- Patients who participated in a clinical trial for first-line treatment of MM during the study period.
- Patients who are alive, but do not give their IC.
- Patients with MM who did not receive treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the first-line treatment regimens
Time frame: Up to approximately 5 months
Number of patients in the different first-line treatment regimens, in terms of the main drug used in patients diagnosed de novo with MM who were not candidates for autologous stem cell transplantation (ASCT)
9 secondary outcomes
Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain
Time frame: Up to approximately 5 months
Description of the characteristics of patients with a diagnosis of MM who were not candidates for ASCT in Spain
Time frame: Up to approximately 5 months
Progression-free survival (PFS)
Time frame: Up to approximately 5 months
Overall survival (OS)
Time frame: Up to approximately 5 months
Overall response rate
Time frame: Up to approximately 5 months
Duration of response
Time frame: Up to approximately 5 months
Patients who receive second-line treatment
Time frame: Up to approximately 5 months
Patients who underwent dose adjustment or switched treatment
Time frame: Up to approximately 5 months
Patients who discontinued treatment
Time frame: Up to approximately 5 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 4 Feb 2019.
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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.
Giselle Lostaunau, MD study director
Celgene
20 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 20 sites in Spain.
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 3 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. 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?
Description of the first-line treatment regimens (time frame: Up to approximately 5 months). 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 4 Feb 2019.