Multiple MyelomaCPS MYELOMENCT04309942
Evaluation Study on Performance of Guided Clinical Pharmacy Consultation in Patients With Multiple Myeloma on First Oral Anticancer Treatment
A study testing Guided Clinical Pharmacy Consultation in people with Multiple Myeloma, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
Trial summary
Nowadays, more and more patients are receiving anticancer treatment by mouth and oral chemotherapy is a challenge for our health system as patients become autonomous and responsible for following their oral anti-cancer treatment at home. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Guided Clinical Pharmacy Consultation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Mar 2020to 30 May 2023
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients being treated for multiple myeloma receiving their first oral anticancer treatment.
- All patients being treated for multiple myeloma by autologous peripheral stem cell graft following the Revlimid - Velcade - Dexamethazone protocol
- All patients who cannot be treated for multiple myeloma by autologous peripheral stem cell graft and who are following the Revlimid - Dexamethazone protocol
- All patients who have given written informed consent.
- All patients who have signed the consent form.
- All patients covered by a health insurance scheme
Who cannot join
- All patients requiring help at home from a nurse for taking their oral treatment
- All patients participating in another category 1 research project.
- All patients in an exclusion period determined by another study.
- All patients for whom it is impossible to give enlightened information.
- All patients who are pregnant or breastfeeding
Trial locations and contacts
3 sites in 1 country.
France3 sites
Dijon University Hospital Pharmacy
Dijon, 21000
Nîmes University Hospital
Nîmes, Occitanie, 30029
Perpignan Hospital Center
Perpignan, 66000
About this study
Official title: An Evaluation Study on the Performance of a Guided Clinical Pharmacy Consultation for Patients With Multiple Myeloma Following Their First Oral Anticancer Treatment
Nowadays, more and more patients are receiving anticancer treatment by mouth and oral chemotherapy is a challenge for our health system as patients become autonomous and responsible for following their oral anti-cancer treatment at home.
According to the French National Cancer Institute around 5.000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase. It is more common in people aged over 70. The patterns of oral anticancer medication for multiple myeloma are complex and these patients do not always follow their treatment correctly. A clinical pharmaceutical consultation guide was designed to overcome this problem.Our hypothesis is that the guided consultation would minimize the rate of discrepancies observed compared with the usual, standard type of management.
The main objective is therefore to evaluate the performance of this guided consultation (interventional group) in comparison with a control group (standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.
Read the detailed description
Nowadays, more and more patients are receiving anticancer treatment by mouth. In this context, the development of oral chemotherapy represents a challenge to our health system as it means adapting the hospital's organization and making it safer to manage patients who are becoming autonomous and responsible for following their oral anti-cancer treatment at home.
According to the French National Cancer Institute, around 5,000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase year by year. It is more common in people aged over 70. Patients treated have several risk factors for not respecting medication adherence such as age, polypharmacy related to the presence of other chronic pathologies, and associated comorbidities. Furthermore, the patterns of administering oral anticancer medication for multiple myeloma are complex.
In a previous study we designed a clinical pharmaceutical consultation guide with a view to improving patients' adherence to their oral anticancer treatment. This guide was designed and validated by a multidisciplinary workgroup to ensure that it was readable, understandable and easy to memorize for the patients being treated for multiple myeloma. The guide was designed so that the information given was reproducible from one patient to another, whoever the pharmacist might be, by standardizing the information given. Our hypothesis is that the guided consultation would make it possible to minimize the rate of discordance observed compared with the usual, standard type of management.
The main objective of this study is to evaluate the performance of the guided consultation (Intervention) by evaluating the rate of discrepancies observed compared with the theoretical therapeutic pattern prescribed, compared with a control group(standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.
Secondary objectives are:
- For both groups in the study, evaluate the patients' level of knowledge and understanding of their treatment.
- In the interventional group, evaluate the acceptability of the intervention by the patient.
- For both groups in the study, evaluate the attitude of the patients when faced with intercurrent events (foreseeable with oral anticancer treatment) for example : fever over 38.5°C, nosebleeds and /or bleeding gums, breathlessness, respiratory difficulties, chest pain, swelling, pain or redness in the legs, digestive difficulties, insomnia, fatigue, tingling, numb fingers or toes.
- For both groups in the study, evaluate the adherence to treatment (adherence rate in percentages).
- Evaluate the rate of discrepancies per item : treatment started in due time, right molecule taken at the right moment, respect of days when no medication is to be taken, day when treatment is to be stopped.
- Conditions
- Multiple Myeloma
- Being tested
- Guided Clinical Pharmacy Consultation
- Keywords
- Multiple Myeloma, Oral anticancer treatment, Observance
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided Clinical Pharmacy ConsultationOther
These patients will have the benefit of a Guided Clinical Pharmacy Consultation
| Study group | Role | What they receive |
|---|---|---|
| Guided Clinical Pharmacy Consultation group | Experimental | Patients following either Revlimid - Velcade - Dexamethasone or Revlimid - Dexamethasone protocols with the benefit of a Guided Clinical Pharmacy Consultation before beginning oral anticancer treatment for multiple myeloma. Receives: Other: Guided Clinical Pharmacy Consultation |
| Standard group | No intervention | Patients following either Revlimid - Velcade - Dexamethazone or Revlimid - Dexamethazone protocols but without the benefit of a Guided Clinical Pharmacy Consultation before beginning oral anticancer treatment for multiple myeloma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who had the benefit of a Guided Clinical Pharmacy Consultation
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Measured: End of treatment. Day 21 +/- 5 days
Observance of treatment by patients following Revlimid - Dexamethazone protocol who had the benefit of the Guided Clinical Pharmacy Consultation
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Measured: End of treatment. Day 28 +/- 5 days
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who did not not have the benefit of a Guided Clinical Pharmacy Consultation
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Measured: End of treatment. Day 21 +/- 5 days
Observance of treatment by patients following Revlimid - Dexamethazone protocol who did not have the benefit of the Guided Clinical Pharmacy Consultation
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage
Measured: End of treatment. Day 28 +/- 5 days
Secondary outcomes (20)
Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment as explained in the guide given at the time of the consultation for patients benefitting from the guided clinical pharmacy consultation
Measured: End of treatment. Day 21 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment.
Measured: End of treatment. Day 21 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment as explained in the guide given at the time of the consultation for patients benefitting from the guided clinical pharmacy consultation
Measured: End of treatment. Day 28 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation
Percentage of right answers to the self-questionnaire testing patient's knowledge and understanding of treatment.
Measured: End of treatment. Day 28 +/- 5 days
System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
Measured: End of treatment. Day 21 +/- 5 days
System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
Measured: End of treatment. Day 21 +/- 5 days
System Usability Score for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
Measured: End of treatment. Day 28 +/- 5 days
System Usability Score for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
The System Usability Score is a set of 10 questions with a 5-point Lickert scale ranging from "I disagree" to "I completely agree". The satisfaction score ranges from 0 to 100.
Measured: End of treatment. Day 28 +/- 5 days
Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
The following events are that may have affected treatment observance are noted:
fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
Measured: End of treatment. Day 21 +/- 5 days
Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
The following events are that may have affected treatment observance are noted:
fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
Measured: End of treatment. Day 21 +/- 5 days
Semi-directive interview for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
The following events are that may have affected treatment observance are noted:
fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
Measured: End of treatment. Day 28 +/- 5 days
Semi-directive interview for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
The following events are that may have affected treatment observance are noted:
fever over 38.5°, Nosebleeds or bleeding gums, Breathlessness, respiratory difficulties, Chest pain, Swelling, pain or redness in the legs, Digestive difficulties, Insomnia, Fatigue, Tingling, Numb fingers or toes
Measured: End of treatment. Day 28 +/- 5 days
Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
Measured: End of treatment. Day 21 +/- 5 days
Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who did not benefit from the guided clinical pharmacy consultation.
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
Measured: End of treatment. Day 21 +/- 5 days
Pill-count for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
Measured: End of treatment. Day 28 +/- 5 days
Pill-count for patients following Revlimid - Dexamethazone protocol who did not benefit from the guided clinical pharmacy consultation.
Treatment observance rate as a percentage deduced from the number of pills prescribed and the number of pills taken.
Measured: End of treatment. Day 28 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who benefitted from the Guided Clinical Pharmacy Consultation
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
Measured: End of treatment. Day 21 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
Measured: End of treatment. Day 21 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who benefitted from the Guided Clinical Pharmacy Consultation
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
Measured: End of treatment. Day 28 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
The following items recorded on the patient's journal - treatment begun in due time, right molecule taken at the right time, respect for days without medication, day when treatment was stopped - will be converted into a percentage rate of discrepancies.
Measured: End of treatment. Day 28 +/- 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Mar 2020
- Primary completion30 May 2023
- Study completion30 May 2023
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 Centre Hospitalier Universitaire de NīmesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentric, prospective, randomized controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- Perpignan Hospital Center, Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309942
- Sponsor's protocol ID
- NIMAO/2018-01/MF
- Acronym
- CPS MYELOME
- Status last verified
- Sep 2023
- First submitted
- 12 Mar 2020
- Last updated
- 8 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation Study on the Performance of a Guided Clinical Pharmacy Consultation for Patients With Multiple Myeloma Following Their First Oral Anticancer Treatment
- ClinicalTrials.gov ID
- NCT04309942
- Acronym / sponsor ID
- CPS MYELOME / NIMAO/2018-01/MF
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Oral anticancer treatment, Observance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- Perpignan Hospital Center, Centre Hospitalier Universitaire Dijon
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 17 Mar 2020 (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.
Nowadays, more and more patients are receiving anticancer treatment by mouth and oral chemotherapy is a challenge for our health system as patients become autonomous and responsible for following their oral anti-cancer treatment at home.
According to the French National Cancer Institute around 5.000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase. It is more common in people aged over 70. The patterns of oral anticancer medication for multiple myeloma are complex and these patients do not always follow their treatment correctly. A clinical pharmaceutical consultation guide was designed to overcome this problem.Our hypothesis is that the guided consultation would minimize the rate of discrepancies observed compared with the usual, standard type of management.
The main objective is therefore to evaluate the performance of this guided consultation (interventional group) in comparison with a control group (standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.
Detailed description
Nowadays, more and more patients are receiving anticancer treatment by mouth. In this context, the development of oral chemotherapy represents a challenge to our health system as it means adapting the hospital's organization and making it safer to manage patients who are becoming autonomous and responsible for following their oral anti-cancer treatment at home.
According to the French National Cancer Institute, around 5,000 new cases of multiple myeloma (MM) are detected each year, and this figure is on the increase year by year. It is more common in people aged over 70. Patients treated have several risk factors for not respecting medication adherence such as age, polypharmacy related to the presence of other chronic pathologies, and associated comorbidities. Furthermore, the patterns of administering oral anticancer medication for multiple myeloma are complex.
In a previous study we designed a clinical pharmaceutical consultation guide with a view to improving patients' adherence to their oral anticancer treatment. This guide was designed and validated by a multidisciplinary workgroup to ensure that it was readable, understandable and easy to memorize for the patients being treated for multiple myeloma. The guide was designed so that the information given was reproducible from one patient to another, whoever the pharmacist might be, by standardizing the information given. Our hypothesis is that the guided consultation would make it possible to minimize the rate of discordance observed compared with the usual, standard type of management.
The main objective of this study is to evaluate the performance of the guided consultation (Intervention) by evaluating the rate of discrepancies observed compared with the theoretical therapeutic pattern prescribed, compared with a control group(standard management) for patients with multiple myeloma on their first cure of oral anticancer medication.
Secondary objectives are:
- For both groups in the study, evaluate the patients' level of knowledge and understanding of their treatment.
- In the interventional group, evaluate the acceptability of the intervention by the patient.
- For both groups in the study, evaluate the attitude of the patients when faced with intercurrent events (foreseeable with oral anticancer treatment) for example : fever over 38.5°C, nosebleeds and /or bleeding gums, breathlessness, respiratory difficulties, chest pain, swelling, pain or redness in the legs, digestive difficulties, insomnia, fatigue, tingling, numb fingers or toes.
- For both groups in the study, evaluate the adherence to treatment (adherence rate in percentages).
- Evaluate the rate of discrepancies per item : treatment started in due time, right molecule taken at the right moment, respect of days when no medication is to be taken, day when treatment is to be stopped.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicentric, prospective, randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Guided Clinical Pharmacy Consultation group | Experimental | Other: Guided Clinical Pharmacy ConsultationPatients following either Revlimid - Velcade - Dexamethasone or Revlimid - Dexamethasone protocols with the benefit of a Guided Clinical Pharmacy Consultation before beginning oral anticancer treatment for multiple myeloma. |
| Standard group | No intervention | –Patients following either Revlimid - Velcade - Dexamethazone or Revlimid - Dexamethazone protocols but without the benefit of a Guided Clinical Pharmacy Consultation before beginning oral anticancer treatment for multiple myeloma. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- All patients being treated for multiple myeloma receiving their first oral anticancer treatment.
- All patients being treated for multiple myeloma by autologous peripheral stem cell graft following the Revlimid - Velcade - Dexamethazone protocol
- All patients who cannot be treated for multiple myeloma by autologous peripheral stem cell graft and who are following the Revlimid - Dexamethazone protocol
- All patients who have given written informed consent.
- All patients who have signed the consent form.
Key exclusion criteria (5 listed)
- All patients requiring help at home from a nurse for taking their oral treatment
- All patients participating in another category 1 research project.
- All patients in an exclusion period determined by another study.
- All patients for whom it is impossible to give enlightened information.
- All patients who are pregnant or breastfeeding
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 |
|---|---|---|
| Guided Clinical Pharmacy ConsultationThese patients will have the benefit of a Guided Clinical Pharmacy Consultation | Other | Guided Clinical Pharmacy Consultation group |
Primary outcome
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who had the benefit of a Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 21 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Observance of treatment by patients following Revlimid - Dexamethazone protocol who had the benefit of the Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 28 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who did not not have the benefit of a Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 21 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage.
Observance of treatment by patients following Revlimid - Dexamethazone protocol who did not have the benefit of the Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 28 +/- 5 days
The rate of discrepancies between the actual prescription and what the patient has noted on the daily report will be measured as a percentage
20 secondary outcomes
Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation
Time frame: End of treatment. Day 21 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation
Time frame: End of treatment. Day 28 +/- 5 days
Results of the self-questionnaire for patients following the Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation
Time frame: End of treatment. Day 28 +/- 5 days
System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
System Usability Score for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
System Usability Score for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 28 +/- 5 days
System Usability Score for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 28 +/- 5 days
Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
Semi-directive interview for patients following Revlimid - Velcade - Dexamethasone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
Semi-directive interview for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 28 +/- 5 days
Semi-directive interview for patients following Revlimid - Dexamethazone protocol who did not have the benefit of the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 28 +/- 5 days
Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
Pill-count for patients following Revlimid - Velcade - Dexamethasone protocol who did not benefit from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 21 +/- 5 days
Pill-count for patients following Revlimid - Dexamethazone protocol who benefitted from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 28 +/- 5 days
Pill-count for patients following Revlimid - Dexamethazone protocol who did not benefit from the guided clinical pharmacy consultation.
Time frame: End of treatment. Day 28 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who benefitted from the Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 21 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Velcade - Dexamethasone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 21 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who benefitted from the Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 28 +/- 5 days
Rate of discrepancies per item in patients on Revlimid - Dexamethazone protocol who did not benefit from the Guided Clinical Pharmacy Consultation
Time frame: End of treatment. Day 28 +/- 5 days
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 8 Sep 2023.
- Individual participant dataSharing planned: No
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided Clinical Pharmacy Consultation in people with Multiple Myeloma, run by Centre Hospitalier Universitaire de Nīmes at 3 sites 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 6 inclusion and 5 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Observance of treatment by patients following Revlimid - Velcade - Dexamethasone protocol who had the benefit of a Guided Clinical Pharmacy Consultation (time frame: End of treatment. Day 21 +/- 5 days). 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 8 Sep 2023.