Relapse and/or Refractory Multiple MyelomaNCT04135963
A Study of People With Multiple Myeloma (MM) in Portugal (CharisMMa-Portugal)
An observational study of Relapse and/or Refractory Multiple Myeloma, run by Takeda at 8 sites in Portugal.
Trial summary
The main aim of this study is to see how people with MM respond to previous or current treatment. Participants will be treated according to their clinic's standard practice. Each participant will fill out a study questionnaire during a routine doctor visit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapse and/or Refractory Multiple Myeloma
- How many people
- 62 participants
- Where
- 8 sitesPortugal
- Study dates
- 31 Jul 2020to 30 Sep 2022
- 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: Participants with a diagnosis of MM with symptomatic R/R disease receiving treatment in Portugal.
Who may be able to join
- At least one previous treatment line.
- Symptomatic R/R disease in the previous 6 months to study enrolment.
- Receiving treatment with an accurate and thorough data fulfilled in their participant's medical records available at the study site.
- On regular follow-up for relapse and/or refractory disease during the recruitment period at the study site.
- Capable of understanding and completing both QoL questionnaires (EORTC QLQ-C30 and EORTC QLQ-MY20).
Who cannot join
- Diagnosed with MM more than 5 years previous to inclusion in this study.
- Diagnosed with any malignancy other than MM or its complications within the past 5 years.
- Currently participating in a clinical trial for his MM or having participated in a clinical trial within 5 years before inclusion.
- Diagnosed with any hematological disease other than MM or its complications.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Portugal8 sites
Centro Clinico Academico Hospital de Braga
Braga, 4710-243
Centro Hospitalar e Universitario de Coimbra. EPE
Coimbra, 3004-561
Instituto Portugues de Oncologia de Lisboa Francisco Gentil (IPO)
Lisbon, 1099-023
Centro Hospitalar Lisboa Norte EPE - Hospital de Santa Maria
Lisbon, 1649-028
Centro Hospitalar Universitario do Porto, E.P.E.
Porto, 4099-001
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
Porto, 4200-072
Centro Hospitalar Universitario de Sao Joao, EPE,
Porto, 4200-319
Centro Hospitalar de Vila Nova de Gaia/Espinho, EPE,
Vila Nova de Gaia, 4434-502
About this study
Official title: Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Portugal: an Observational, Multicenter Study
The main aim of this study is to see how people with MM respond to previous or current treatment.
Participants will be treated according to their clinic's standard practice. Each participant will fill out a study questionnaire during a routine doctor visit. Information collected from past medical records will also be used.
Read the detailed description
This is a non- interventional, retrospective epidemiological study of participants with MM. The study will characterize MM participants with symptomatic relapse and/or refractory (R/R) disease.
The study will enroll approximately 151 participants. The study will have a retrospective data collection referring to previous 5 years from participants' records and medical charts regarding diagnosis, disease activity, treatment patterns, and healthcare resources while quality of life (QoL) will be obtained from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC QLQ-MY20 questionnaires. All participants will be enrolled in one observational group.
This multi-center trial will be conducted in Portugal. The overall time to participate in this study is limited to completion of a questionnaire at the time of joining the study.
- Keywords
- Multiple Myeloma
- 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 |
|---|---|---|
| Participants with MM | Participants diagnosed with MM from 8 investigative sites will be observed retrospectively for previous 5 years before enrollment until Day 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MM Participants Categorized by Sociodemographic Variables
The sociodemographic variables will include age (in years), sex (male or female), body mass index (BMI), area of residence (rural or urban), educational level (illiterate, no studies (can only read/write), primary studies, secondary studies, or university studies), cohabitation (lives alone, lives with the family, lives alone with help from a caregiver, daily, 2-3 times/week, permanent or night-time), degree of dependence (independent, dependent grade I- requires help to perform instrumental activities of daily living (IADL) at least once a day, dependent grade II- needs help to perform IADLs 2 or 3 times a day or dependent grade III- needs help to perform IADLs several times a day),working situation (unemployed, in active employment, temporarily/permanently disabled, retired, student, other, need for financial assistance (yes/no), physical activity (high, moderate/low, inactive), smoking habit (yes/no), alcohol use (yes/no).
Measured: Day 1
Number of MM Participants Categorized by Clinical Variables on Diagnosis and During Previous Relapses
Clinical variables will include age (at diagnosis); MM type; international staging system (ISS) disease stage; Revised-ISS (R-ISS) disease stage; SliMCRAB signs at time of diagnosis: plasma cell bone marrow infiltration greater than or equal to (>=) 60 percent (%), serum free light chain (FLC) ratio >=100, >1 focal lesion visible on magnetic resonance imaging (MRI) with 5 millimeter (mm) or greater, increased blood calcium, renal failure, anemia, bone lesions: one or more osteolytic lesion on standard radiograph, computed tomography (CT) or Positron emission tomography-CT (PET-CT); cytogenetic abnormalities at time of diagnosis (t[4;14], t[11;14], t[14;16], t[14;20], t[6;14], trisomies, d[17p], g[1q]/ others); risk according to cytogenetic profile at diagnosis (mSMART v2 and mSMART v3); previous relapses (before the latest); stem cell transplant (yes/no); eastern cooperative oncology group (ECOG: 0-4) on diagnosis.
Measured: Day 1
Number of MM Participants Categorized by Clinical Variables at Last R/R Episode
Clinical variables include date of latest symptomatic relapse and/or refractory episode; ISS disease stage, CRAB signs; other clinical variables (plasmacytomas: medullary or extramedullary, diffuse osteopenia, fractures, neurological symptoms, infections, lactate dehydrogenase levels, paraprotein levels, free light chain levels); concomitant diseases (diabetes, neuropathy, chronic obstructive pulmonary disease, cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders); cytogenetic abnormalities at diagnosis; risk according to cytogenetic profile at relapse; treatment started after latest symptomatic relapse and/or refractory episode.
Measured: Day 1
Number of Participants Categorized by Current Treatment
Type of treatment will include therapeutic group.
Measured: Day 1
Secondary outcomes (3)
Number of Participants Categorized by Sociodemographic Characteristics at the Latest Symptomatic R/R Episode per Type of Treatment
Sociodemographic variables will include age (in years), sex (male or female), BMI, area of residence (rural or urban), educational level (illiterate, no studies (can only read/write), primary studies, secondary studies, or university studies), cohabitation (lives alone, lives with the family, lives alone with help from a caregiver, daily, 2-3 times/week, permanent or night-time), degree of dependence (independent, dependent grade I - requires help to perform IADL at least once a day, dependent grade II - needs help to perform IADLs 2 or 3 times a day or dependent grade III - needs help to perform IADLs several times a day), need for financial assistance (yes/no), smoking habit (yes/no), alcohol use (yes/no).
Measured: Day 1
Number of MM Participants Categorized by Clinical Variables at Latest Symptomatic R/R Episode per Type of MM
Clinical variables will include- date of latest symptomatic R/R episode; SLiMCRAB signs at latest symptomatic R/R episode: plasma cell bone marrow infiltration >=60 %, serum FLC ratio >=100, >1 focal lesion visible on MRI with 5 mm or greater, increased blood calcium, renal failure, anemia, bone lesions: one or more osteolytic lesion on standard radiograph, CT or PET-CT; other clinical variables at latest symptomatic R/R episode include- plasmacytomas (medullary/extramedullary); diffuse osteopenia; fractures; neurological symptoms (MM related); infections; lactose dehydrogenase (LDH); paraprotein levels (gram per liter [g/L]) (serum and urine) free light chain levels (g/L) (serum and urine).
Measured: Day 1
Number of Participants Categorized by Relevant Variables that are not Currently Collected in Clinical Record and Could Influence in the Disease Management at Relapse
New relevant variables will include factors mentioned by the participant as relevant to the disease management (example, family support, employment status); type of transportation used to receive treatment; mean cost in Euros per month with transportation to receive treatment, mean of hospital visits per month since last treatment was initiated, mean scheduled and non-scheduled participant's visits to the hospital, days of hospitalization, and specialists consulted; consultations, days of hospitalization, medical appointments and specialists consulted by type of treatment.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start31 Jul 2020
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapse and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04135963
- Sponsor's protocol ID
- RRMM-5017
- Other IDs
- U1111-1234-4861
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2019
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Sociodemographic Characterization of Multiple Myeloma Patients With Symptomatic Relapse and/or Refractory Disease in Portugal: an Observational, Multicenter Study
- ClinicalTrials.gov ID
- NCT04135963
- Acronym / sponsor ID
- RRMM-5017
- Keywords
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 23 Oct 2019 (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.
The main aim of this study is to see how people with MM respond to previous or current treatment.
Participants will be treated according to their clinic's standard practice. Each participant will fill out a study questionnaire during a routine doctor visit. Information collected from past medical records will also be used.
Detailed description
This is a non- interventional, retrospective epidemiological study of participants with MM. The study will characterize MM participants with symptomatic relapse and/or refractory (R/R) disease.
The study will enroll approximately 151 participants. The study will have a retrospective data collection referring to previous 5 years from participants' records and medical charts regarding diagnosis, disease activity, treatment patterns, and healthcare resources while quality of life (QoL) will be obtained from European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-C30 and EORTC QLQ-MY20 questionnaires. All participants will be enrolled in one observational group.
This multi-center trial will be conducted in Portugal. The overall time to participate in this study is limited to completion of a questionnaire at the time of joining the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with MM | – | –Participants diagnosed with MM from 8 investigative sites will be observed retrospectively for previous 5 years before enrollment until Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a diagnosis of MM with symptomatic R/R disease receiving treatment in Portugal.
Key inclusion criteria (5 listed)
- At least one previous treatment line.
- Symptomatic R/R disease in the previous 6 months to study enrolment.
- Receiving treatment with an accurate and thorough data fulfilled in their participant's medical records available at the study site.
- On regular follow-up for relapse and/or refractory disease during the recruitment period at the study site.
- Capable of understanding and completing both QoL questionnaires (EORTC QLQ-C30 and EORTC QLQ-MY20).
Key exclusion criteria (4 listed)
- Diagnosed with MM more than 5 years previous to inclusion in this study.
- Diagnosed with any malignancy other than MM or its complications within the past 5 years.
- Currently participating in a clinical trial for his MM or having participated in a clinical trial within 5 years before inclusion.
- Diagnosed with any hematological disease other than MM or its complications.
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
Number of MM Participants Categorized by Sociodemographic Variables
Time frame: Day 1
The sociodemographic variables will include age (in years), sex (male or female), body mass index (BMI), area of residence (rural or urban), educational level (illiterate, no studies (can only read/write), primary studies, secondary studies, or university studies), cohabitation (lives alone, lives with the family, lives alone with help from a caregiver, daily, 2-3 times/week, permanent or night-time), degree of dependence (independent, dependent grade I- requires help to perform instrumental activities of daily living (IADL) at least once a day, dependent grade II- needs help to perform IADLs 2 or 3 times a day or dependent grade III- needs help to perform IADLs several times a day),working situation (unemployed, in active employment, temporarily/permanently disabled, retired, student, other, need for financial assistance (yes/no), physical activity (high, moderate/low, inactive), smoking habit (yes/no), alcohol use (yes/no).
Number of MM Participants Categorized by Clinical Variables on Diagnosis and During Previous Relapses
Time frame: Day 1
Clinical variables will include age (at diagnosis); MM type; international staging system (ISS) disease stage; Revised-ISS (R-ISS) disease stage; SliMCRAB signs at time of diagnosis: plasma cell bone marrow infiltration greater than or equal to (>=) 60 percent (%), serum free light chain (FLC) ratio >=100, >1 focal lesion visible on magnetic resonance imaging (MRI) with 5 millimeter (mm) or greater, increased blood calcium, renal failure, anemia, bone lesions: one or more osteolytic lesion on standard radiograph, computed tomography (CT) or Positron emission tomography-CT (PET-CT); cytogenetic abnormalities at time of diagnosis (t[4;14], t[11;14], t[14;16], t[14;20], t[6;14], trisomies, d[17p], g[1q]/ others); risk according to cytogenetic profile at diagnosis (mSMART v2 and mSMART v3); previous relapses (before the latest); stem cell transplant (yes/no); eastern cooperative oncology group (ECOG: 0-4) on diagnosis.
Number of MM Participants Categorized by Clinical Variables at Last R/R Episode
Time frame: Day 1
Clinical variables include date of latest symptomatic relapse and/or refractory episode; ISS disease stage, CRAB signs; other clinical variables (plasmacytomas: medullary or extramedullary, diffuse osteopenia, fractures, neurological symptoms, infections, lactate dehydrogenase levels, paraprotein levels, free light chain levels); concomitant diseases (diabetes, neuropathy, chronic obstructive pulmonary disease, cardiovascular disease, liver failure, psychiatric and/or neurological disorders, any other secondary disorders); cytogenetic abnormalities at diagnosis; risk according to cytogenetic profile at relapse; treatment started after latest symptomatic relapse and/or refractory episode.
Number of Participants Categorized by Current Treatment
Time frame: Day 1
Type of treatment will include therapeutic group.
3 secondary outcomes
Number of Participants Categorized by Sociodemographic Characteristics at the Latest Symptomatic R/R Episode per Type of Treatment
Time frame: Day 1
Number of MM Participants Categorized by Clinical Variables at Latest Symptomatic R/R Episode per Type of MM
Time frame: Day 1
Number of Participants Categorized by Relevant Variables that are not Currently Collected in Clinical Record and Could Influence in the Disease Management at Relapse
Time frame: Day 1
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 23 Oct 2023.
- To obtain more information about this study, click this link.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapse and/or Refractory Multiple Myeloma, run by Takeda at 8 sites in Portugal.
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 5 inclusion and 4 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 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Portugal. 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 MM Participants Categorized by Sociodemographic Variables (time frame: Day 1). The study lists 4 primary outcomes in all. 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 23 Oct 2023.