NCT04309942

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-myeloma

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable multiple-myeloma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

3.2 years

First QC Date

March 12, 2020

Last Update Submit

September 7, 2023

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaOral anticancer treatmentObservance

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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

    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.

    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

    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

    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

    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.

    End of treatment. Day 21 +/- 5 days

  • +15 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Guided Clinical Pharmacy ConsultationOTHER

These patients will have the benefit of a Guided Clinical Pharmacy Consultation

Guided Clinical Pharmacy Consultation group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 for whom it is impossible to give enlightened information.
  • All patients who are pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nîmes University Hospital

Nîmes, Occitanie, 30029, France

Location

Dijon University Hospital Pharmacy

Dijon, 21000, France

Location

Perpignan Hospital Center

Perpignan, 66000, France

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Multicentric, prospective, randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2020

First Posted

March 17, 2020

Study Start

March 1, 2020

Primary Completion

May 30, 2023

Study Completion

May 30, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)