Multiple MyelomaQoLMMBuSNCT02946333
A Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
An observational study of Multiple Myeloma, run by Celgene at 65 sites in Spain.
Trial summary
Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this protocol can participate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 355 participants
- Where
- 65 sitesSpain
- Study dates
- 25 Dec 2016to 31 Oct 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: At least 450 patients with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start drug treatment for the study disease will be enrolled.
Who may be able to join
- Patient ≥ 18 years of age.
- Patient with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start treatment for the study disease.
- Patient who is capable of understanding and filling in the study questionnaires.
- Patient who has granted his or her informed consent in writing.
Who cannot join
- Patient who is participating in the active phase of treatment of any clinical trial during the study period.
Trial locations and contacts
65 sites in 1 country.
65 sites in 1 country
Spain65 sites
Complexo Hospitalario Universitario de A Coruña
A Coruña, Galicia, 15006
Hospital Punta de Europa
Algeciras, Andalusia, 11207
Hospital de La Ribera
Alzira, Valencia, 46600
Hospital de Antequera
Antequera, Andalusia, 29200
Complejo Hospitalario de Ávila
Ávila, 05004
Hospital del Mar
Barcelona, Catalonia, 08003
Hospital Santa Creu i Sant Pau
Barcelona, Catalonia, 08026
Hospital Vall Hebrón
Barcelona, Catalonia, 08035
Hospital de Basurto
Bilbao, Basque Country, 48013
Hospital Universitario de Burgos
Burgos, Castille and León, 09006
Hospital General Castellón
Castellon, Valencia, 12004
Hospital Reina Sofía
Córdoba, Andalusia, 14004
Hospital Universitario de Getafe
Getafe, Madrid, 28905
Hospital General de Granollers
Granollers, Catalonia, 08402
Hospital Huercal Olvera
Huercal Olvera, Andalusia, 04600
Hospital General Jaén
Jaén, Andalusia, 23007
Hospital Jerez de la Frontera
Jerez de la Frontera, Andalusia, 11407
Hospital ICO Durán y Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
ICO Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 35010
Hospital Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, 38010
Hospital Arnau Vilanova de Lleida
Lleida, Catalonia, 25198
Complejo Hospitalario Llerena-Zafra
Llerena, Extremadura, 06900
Hospital Lucus Augustí
Lugo, Galicia, 27003
Hospital de la Princesa
Madrid, Madrid, 28006
Hospital General Universitario Gregorio Marañon
Madrid, Madrid, 28007
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital Infanta Leonor
Madrid, 28031
Hospital Ramón y Cajal
Madrid, 28031
Hospital La Paz
Madrid, 28046
Clinico Univ. Virgen de la Victoria
Málaga, Andalusia, 29010
Hospital Carlos Haya
Málaga, Andalusia, 29010
Hospital de Costa del Sol
Málaga, Andalusia, 29603
Fundació Althaia
Manresa, Catalonia, 08243
Hospital de Mérida
Mérida, Extremadura, 06800
Hospital de Motril
Motril, Andalusia, 18600
Complejo Hospitalario de Navarra
Navarra, Navarre, 31008
Complexo Hospitalario Universitario de Ourense
Ourense, Galicia, 32005
Hospital Son Espases
Palma de Mallorca, Balearic Islands, 07120
Hospital Son Llàtzer
Palma de Mallorca, Balearic Islands, 07198
Complejo Hospitalario Navarra
Pamplona, Navarre, 31008
Complexo Hospitalario de Pontevedra
Pontevedra, Galicia, 36071
Hospital Valle de los Pedroches Pozoblanco
Pozoblanco, Andalusia, 14400
Hospital Quirón
Pozuelo de Alarcón, Madrid, 28223
Hospital Puerto Real
Puerto Real, Andalusia, 11510
Parc Taulí
Sabadell, Catalonia, 08208
Hospital Clínico Universitario de Salamanca
Salamanca, Castille and León, 37007
Hospital Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Canary Islands, 38010
Hospital Universitario Canarias
Santa Cruz de Tenerife, Islas Canaria, 38320
Hospital de Macarena
Seville, Andalusia, 29200
Mutua Terrassa
Terrassa, Catalonia, 08221
Hospital de Galadakao
Usansolo, Basque Country, 48960
Hospital Arnau Vilanova Valencia
Valencia, Valencia, 46015
Hospital Doctor Peset
Valencia, Valencia, 46017
Hospital La Fe Valencia
Valencia, Valencia, 46026
Hospital La Ribera
Valencia, Valencia, 46600
Hospital Universitario La Fe
Valencia, 46026
Hospital Clínico de Valladolid
Valladolid, Castille and León, 47003
Complexo Hospitalario Universitario de Vigo
Vigo, Galicia, 36312
Hospital de Txagorritxu
Vitoria-Gasteiz, Basque Country, 01009
Hospital Miguel Servet
Zaragoza, Aragon, 50009
Hospital Miguel Servet
Zaragoza, 50009
About this study
Official title: Observational Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this protocol can participate. The participating patients must sign an informed consent, which the investigator who will collect the study variables in an electronic case report form (eCRF) will provide to them. The investigators must recruit at least 450 patients in a 24-month period.
Read the detailed description
Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:
- Recruitment period: data collection at the baseline visit, every 4 months +/- 15 days in the first year (month 4, 8 and 12) and every 6 months +/- 1 month in the second year (month 18 and 24).
- Follow-up period: (study will end at 4 years following enrolment of the first patient)
- From month 24 until up to 4 years from enrolment of the first patient, follow-ups will be performed with semi-annual data collections coinciding with the patient's routine clinical practice visits.
- In case of progression, suspension or unexpected termination of treatment (for example due to toxicity), or death, a data collection coinciding with the visit in which any of the cases presented occurs will be performed.
- If a new line of treatment is started, the follow-up model will be started with the same frequency of follow-ups described in point 1 above (month 4, 8, 12, 18 and 24 and semi-annually according to routine clinical practice until up to 4 years from enrolment of the first patient in the study).
- Observation period: Following this 4-year period, an additional 5-year follow-up will be performed only to evaluate the onset of second primary malignant neoplasms. This follow-up during the 5-year observational period will be performed semi-annually (± 1 month) according to routine clinical practice at each site.
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, autologous stem cell transplant (ASCT), QoLMMBuS, healthcare costs
- 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 |
|---|---|---|
| Patient with MM who are not candidates for ASCT | Patients with newly diagnosed MM who are not candidates for ASCT and who are going to start drug treatment for the study disease and patient who is capable of understanding and filling in the study questionnaires At least 450 patients will be enrolled in a 2-year period. Patients must meet all of the inclusion criteria and none of the exclusion criteria and must have previously granted their informed consent in writing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL)
This questionnaire consists of 30 items grouped into 8 dimensions: number of drugs, gait velocity, mood, activities of daily living, health status, nutrition, mental state and comorbidity/habits. It is an instrument that was developed and validated to assess the health status of elderly patients diagnosed with different hematological diseases, including MM. This scale may be a useful instrument in clinical practice as a support tool to predict tolerance to treatment in advanced age. The time required to complete the questionnaire is approximately 10-12 minutes. It will be provided only at the baseline visit for the patient to fill in before starting treatment. The patient must fill it in again each time he or she starts a new line. The questionnaire will be provided by the physician during the visit.
Measured: 4 years
EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)
This is a generic HRQoL questionnaire that contains a descriptive system and a visual analogue scale (VAS) for self-assessment of health status. The EQ-5D-5L's descriptive system contains a description of health state in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 possible responses. The respondent must mark the level of problems, within each dimension, that best describes his or her health state "today". It will be provided at each visit for the patient to fill in before starting treatment: at the baseline visit, approximately every 4 months in the first year (the visits must coincide with the patient's routine clinical practice visit) and after the first year every 6 months to progression. In case of progression and start of a second line of treatment, the questionnaire will start to be filled in with the same frequency initially described (baseline, every 4 months, etc.).
Measured: 4 years
Quality of Life Questionnaire (QLQ-C30)
This is a cancer-specific questionnaire that consists of 30 items structured into 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status scale and, finally, 6 independent items (dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). Values from 1 to 4 are assigned depending on the patient's responses to the item. Only items 29 and 30 are evaluated with scoring from 1 to 7. Scores are standardised to obtain a score from 0 to 100, which determines the level of impact of the cancer on the patient for each scale. High scores on the overall health and functional status scales indicate a better QoL, while high scores on the symptoms scale would indicate a decrease in QoL since they indicate the presence of cancer-related symptoms.
Measured: 4 years
Quality of Life Questionnaire - Multiple Myeloma Module 20 (QLQ-MY20)
This is a specific questionnaire used in combination with the QLQ-C30 generic questionnaire to evaluate quality of life in patients with MM. It consists of 20 items that address four specific domains - disease symptoms, side effects of treatment, future perspective and body image - and analyses various aspects of each dimension. Three of the four domains of the QLQ-MY20 are multi-item scales: Disease symptoms , side effects of treatment and future perspective (includes worry about death and health in the future and thinking about illness). The body image scale is a single-item scale that addresses physical attractiveness. The scores obtained are transformed linearly to a scale from 0 to 100. A high score in the disease symptoms and side effects domains represents a high level of symptoms or problems, while a high score in the future perspective and body image domains represents better outcomes.
Measured: 4 years
Health care cost for Multiple Myeloma (MM) patients
MM-related direct healthcare resources and costs will be evaluated in each line MM treatment will be evaluated. The questionnaire will be provided by the physician during the visit. The resources used since the previous study visit will be collected at each visit.
Measured: 4 years
Secondary outcomes (6)
Time to progression (TTP)
Time that elapses from the start of a treatment up to disease progression.
Measured: 4 years
Progression-free survival (PFS)
Time that elapses from the start of a treatment to disease progression or death, whichever occurs first.
Measured: 4 years
Overall survival (OS)
Time that elapses from the diagnosis of the disease up to the death of the patient for any reason.
Measured: 9 years
Overall response rate
Response measured through the IMWG criteria: Stringent complete response; complete response (CR); very good partial response; partial response (PR); stable disease (SD); progression (P)
Measured: 4 years
Response duration
For each line of treatment for multiple myeloma (MM) during the study period
Measured: 4 years
Treatment-free interval [TFI]
Time between relapse and start of a new treatment (second/third lines)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2016 (estimated)
- Study start25 Dec 2016
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 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
- Prospective
- Enrolment
- 355 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giselle Lostaunau, Senior Medical Advisor MM, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02946333
- Sponsor's protocol ID
- CEL-MIE-2016-01
- Acronym
- QoLMMBuS
- Status last verified
- Nov 2022
- First submitted
- 30 Sep 2016
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
PubMed 33218965
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess Disease Burden, in Terms of Health-related Quality of Life and Direct Healthcare Costs, in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Autologous Stem Cell Transplant (ASCT) in Spain
- ClinicalTrials.gov ID
- NCT02946333
- Acronym / sponsor ID
- QoLMMBuS / CEL-MIE-2016-01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, autologous stem cell transplant (ASCT), QoLMMBuS, healthcare costs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 355 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 25 Dec 2016 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 27 Oct 2016 (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.
Those patients with newly diagnosed Multiple Myeloma (MM) who are not candidates for Autologous Stem Cell Transplant (ASCT) and who meet the screening criteria described in this protocol can participate. The participating patients must sign an informed consent, which the investigator who will collect the study variables in an electronic case report form (eCRF) will provide to them. The investigators must recruit at least 450 patients in a 24-month period.
Detailed description
Following the baseline enrolment visit, the following data corresponding to the patient's visits scheduled according to routine clinical practice will be collected in accordance with the following model:
- Recruitment period: data collection at the baseline visit, every 4 months +/- 15 days in the first year (month 4, 8 and 12) and every 6 months +/- 1 month in the second year (month 18 and 24).
- Follow-up period: (study will end at 4 years following enrolment of the first patient)
- From month 24 until up to 4 years from enrolment of the first patient, follow-ups will be performed with semi-annual data collections coinciding with the patient's routine clinical practice visits.
- In case of progression, suspension or unexpected termination of treatment (for example due to toxicity), or death, a data collection coinciding with the visit in which any of the cases presented occurs will be performed.
- If a new line of treatment is started, the follow-up model will be started with the same frequency of follow-ups described in point 1 above (month 4, 8, 12, 18 and 24 and semi-annually according to routine clinical practice until up to 4 years from enrolment of the first patient in the study).
- Observation period: Following this 4-year period, an additional 5-year follow-up will be performed only to evaluate the onset of second primary malignant neoplasms. This follow-up during the 5-year observational period will be performed semi-annually (± 1 month) according to routine clinical practice at each site.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with MM who are not candidates for ASCT | – | –Patients with newly diagnosed MM who are not candidates for ASCT and who are going to start drug treatment for the study disease and patient who is capable of understanding and filling in the study questionnaires At least 450 patients will be enrolled in a 2-year period. Patients must meet all of the inclusion criteria and none of the exclusion criteria and must have previously granted their informed consent in writing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At least 450 patients with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start drug treatment for the study disease will be enrolled.
Key inclusion criteria (4 listed)
- Patient ≥ 18 years of age.
- Patient with newly diagnosed multiple myeloma (MM) according to IMWG criteria who are not candidates for ASCT and who start treatment for the study disease.
- Patient who is capable of understanding and filling in the study questionnaires.
- Patient who has granted his or her informed consent in writing.
Key exclusion criteria (1 listed)
- Patient who is participating in the active phase of treatment of any clinical trial during the study period.
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
Health-related quality of life (HRQoL)
Time frame: 4 years
This questionnaire consists of 30 items grouped into 8 dimensions: number of drugs, gait velocity, mood, activities of daily living, health status, nutrition, mental state and comorbidity/habits. It is an instrument that was developed and validated to assess the health status of elderly patients diagnosed with different hematological diseases, including MM. This scale may be a useful instrument in clinical practice as a support tool to predict tolerance to treatment in advanced age. The time required to complete the questionnaire is approximately 10-12 minutes. It will be provided only at the baseline visit for the patient to fill in before starting treatment. The patient must fill it in again each time he or she starts a new line. The questionnaire will be provided by the physician during the visit.
EuroQoL 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)
Time frame: 4 years
This is a generic HRQoL questionnaire that contains a descriptive system and a visual analogue scale (VAS) for self-assessment of health status. The EQ-5D-5L's descriptive system contains a description of health state in five dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 possible responses. The respondent must mark the level of problems, within each dimension, that best describes his or her health state "today". It will be provided at each visit for the patient to fill in before starting treatment: at the baseline visit, approximately every 4 months in the first year (the visits must coincide with the patient's routine clinical practice visit) and after the first year every 6 months to progression. In case of progression and start of a second line of treatment, the questionnaire will start to be filled in with the same frequency initially described (baseline, every 4 months, etc.).
Quality of Life Questionnaire (QLQ-C30)
Time frame: 4 years
This is a cancer-specific questionnaire that consists of 30 items structured into 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, nausea and vomiting, pain), a global health status scale and, finally, 6 independent items (dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). Values from 1 to 4 are assigned depending on the patient's responses to the item. Only items 29 and 30 are evaluated with scoring from 1 to 7. Scores are standardised to obtain a score from 0 to 100, which determines the level of impact of the cancer on the patient for each scale. High scores on the overall health and functional status scales indicate a better QoL, while high scores on the symptoms scale would indicate a decrease in QoL since they indicate the presence of cancer-related symptoms.
Quality of Life Questionnaire - Multiple Myeloma Module 20 (QLQ-MY20)
Time frame: 4 years
This is a specific questionnaire used in combination with the QLQ-C30 generic questionnaire to evaluate quality of life in patients with MM. It consists of 20 items that address four specific domains - disease symptoms, side effects of treatment, future perspective and body image - and analyses various aspects of each dimension. Three of the four domains of the QLQ-MY20 are multi-item scales: Disease symptoms , side effects of treatment and future perspective (includes worry about death and health in the future and thinking about illness). The body image scale is a single-item scale that addresses physical attractiveness. The scores obtained are transformed linearly to a scale from 0 to 100. A high score in the disease symptoms and side effects domains represents a high level of symptoms or problems, while a high score in the future perspective and body image domains represents better outcomes.
Health care cost for Multiple Myeloma (MM) patients
Time frame: 4 years
MM-related direct healthcare resources and costs will be evaluated in each line MM treatment will be evaluated. The questionnaire will be provided by the physician during the visit. The resources used since the previous study visit will be collected at each visit.
6 secondary outcomes
Time to progression (TTP)
Time frame: 4 years
Progression-free survival (PFS)
Time frame: 4 years
Overall survival (OS)
Time frame: 9 years
Overall response rate
Time frame: 4 years
Response duration
Time frame: 4 years
Treatment-free interval [TFI]
Time frame: 4 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 22 Nov 2022.
- Derived from this study: PubMed 33218965Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
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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, Senior Medical Advisor MM study director
Celgene
65 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 65 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 4 inclusion and 1 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 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 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?
Health-related quality of life (HRQoL) (time frame: 4 years). The study lists 5 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 NCT02946333, 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 22 Nov 2022.