Multiple MyelomaNCT04045561
Development of a Standardized Reference Guide for Tuning Adherence to Dispense During a Initial Pharmaceutical Consulting (CP ) to the Patient With Multiple Myeloma Oral Chemotherapy Primocure
An observational study of Multiple Myeloma, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2015to 31 Dec 2016
- 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: The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.
Who may be able to join
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.
- Criteria for non-inclusion
- The subject is participating in another study
- The subject is in an exclusion period determined by a previous study
Show all 14Show fewer
- The subject is under the protection of justice, guardianship or curatorship
- It is impossible to give informed information about
- The patient is pregnant, parturient, or breastfeeding
- The patient receives a follow-up by a home nurse for the administration of oral medication
- The patient is treated only with oral chemotherapy in the city
- The patient has early dementia.
- Translated with www.DeepL.com/Translator
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Elaboration of a Standardized Referential Guide of the Information to Optimize the Adherence to be Given During an Initial Pharmaceutical Consultation (CP) to the Patient Suffering From Multiple Myeloma in Primocure Chemotherapy Per os
The hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment.
The aim of this study is therefore to develop a standardised reference guide of information to be provided during prostate cancer in order to optimise the compliance of patients treated for multiple myeloma as a first course of chemotherapy per os.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluating the understanding
Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.
Measured: Day 1
evaluating understanding
Questionnaire. qualitative variables: measurement of their number and
Measured: Day 1
evaluating the quality of information
Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.
Measured: Day 1
evaluating quality of information
Questionnaire. qualitative variables: measurement of their number and percentage.
Measured: Day 1
Secondary outcomes (2)
The time required for the pharmaceutical consultation
minutes
Measured: Day 1
satisfaction des patients
by an Analogue Visual Scale (0-10-very satisfied)
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 posted5 Aug 2019
- Study start1 Jun 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045561
- Sponsor's protocol ID
- LOCAL/2015/MF-01
- Status last verified
- Jul 2019
- First submitted
- 23 Jul 2019
- Last updated
- 18 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elaboration of a Standardized Referential Guide of the Information to Optimize the Adherence to be Given During an Initial Pharmaceutical Consultation (CP) to the Patient Suffering From Multiple Myeloma in Primocure Chemotherapy Per os
- ClinicalTrials.gov ID
- NCT04045561
- Acronym / sponsor ID
- LOCAL/2015/MF-01
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 5 Aug 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 hypothesis is that the implementation of an initial Pharmaceutical Consultation (PC) program based on the provision of standardized information to patients treated for multiple myeloma as a first course of chemotherapy, could optimize their compliance with the delivered per os treatment.
The aim of this study is therefore to develop a standardised reference guide of information to be provided during prostate cancer in order to optimise the compliance of patients treated for multiple myeloma as a first course of chemotherapy per os.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.
Key inclusion criteria (14 listed)
- The patient must be a member or beneficiary of a health insurance plan
- The patient is at least 18 years old
- The patient is treated for multiple myeloma, is naive to any treatment and begins a chemotherapy protocol with oral therapy and whose course of care includes a stay in the Day Hospital or retrocessions.
- Criteria for non-inclusion
- The subject is participating in another study
Key exclusion criteria (0 listed)
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
evaluating the understanding
Time frame: Day 1
Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.
evaluating understanding
Time frame: Day 1
Questionnaire. qualitative variables: measurement of their number and
evaluating the quality of information
Time frame: Day 1
Questionnaire. quantitative variables: measurement of the mean and standard deviation or by their median and quartiles according to their distribution.
evaluating quality of information
Time frame: Day 1
Questionnaire. qualitative variables: measurement of their number and percentage.
2 secondary outcomes
The time required for the pharmaceutical consultation
Time frame: Day 1
satisfaction des patients
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 18 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 14 inclusion and 0 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
evaluating the understanding (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 18 Jun 2026.