Multiple MyelomaNCT03779555
Lenalidomide Adherence in Older Adults
An observational study of Multiple Myeloma, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Medication Event Monitoring System
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 31 Aug 2020
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who are taking lenalidomide.
Who may be able to join
- Age ≥65
- Receiving lenalidomide for treatment of multiple myeloma.
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Able to read and understand English.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Who cannot join
- Estimated life expectancy <6 months.
- Anticipated duration of lenalidomide therapy <3 months.
- Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma
To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Medication Event Monitoring System
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Event Monitoring SystemOther
Also called MEMS
-Microchipped bottle cap
| Study group | Role | What they receive |
|---|---|---|
| Patients taking lenalidomide for multiple myeloma | -Patients will be seen at baseline, 1 month (+/- 1 week), 2 months (3-5 weeks following 1-month assessment), and 3 months (3-5 weeks after 2-month follow-up) Receives: Other: Medication Event Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open
-Participants will be given a pill diary in which they will record if they opened the pill bottle without taking a medication (e.g. to ascertain remaining supply) to adjust the adherence rate accordingly
Measured: Through completion of study (estimated to be 3 months)
Secondary outcomes (1)
Adherence rate as measured by a modified Brief Adherence Rating Scale
- Participants will fill out a brief survey about taking lenalidomide and an estimate of their adherence using a visual analog scale
- Scored 0-100%, 0% = lenalidomide not taken on any days and 100% = lenalidomide taken every day
Measured: Through completion of study (estimated to be 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start13 Dec 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Why it stopped: Principal Investigator left the university
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 Washington University School of MedicineThe 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Responsible party
- Sponsor
- Investigators
- Mark A Fiala, MSW, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779555
- Sponsor's protocol ID
- 201812141
- Status last verified
- Oct 2020
- First submitted
- 17 Dec 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Silberstein AE, Fiala MA, Loh KP, Cordner T, Mian H, Wildes TM. A pilot study of adherence to lenalidomide among older patients with multiple myeloma. J Geriatr Oncol. 2023 Sep;14(7):101560. doi: 10.1016/j.jgo.2023.101560. Epub 2023 Jun 27. No abstract available.
PubMed 37380519
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma
- ClinicalTrials.gov ID
- NCT03779555
- Acronym / sponsor ID
- 201812141
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Principal Investigator left the university
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Alliance for Clinical Trials in Oncology
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 19 Dec 2018 (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.
To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients taking lenalidomide for multiple myeloma | – | Other: Medication Event Monitoring System-Patients will be seen at baseline, 1 month (+/- 1 week), 2 months (3-5 weeks following 1-month assessment), and 3 months (3-5 weeks after 2-month follow-up) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Participants from Siteman Cancer Center and its satellite sites with multiple myeloma who are taking lenalidomide.
Key inclusion criteria (5 listed)
- Age ≥65
- Receiving lenalidomide for treatment of multiple myeloma.
- Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
- Able to read and understand English.
- Able to understand and willing to sign an IRB-approved written informed consent document.
Key exclusion criteria (3 listed)
- Estimated life expectancy <6 months.
- Anticipated duration of lenalidomide therapy <3 months.
- Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.
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 |
|---|---|---|
| Medication Event Monitoring SystemAlso: MEMS-Microchipped bottle cap | Other | Patients taking lenalidomide for multiple myeloma |
Primary outcome
Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open
Time frame: Through completion of study (estimated to be 3 months)
-Participants will be given a pill diary in which they will record if they opened the pill bottle without taking a medication (e.g. to ascertain remaining supply) to adjust the adherence rate accordingly
1 secondary outcome
Adherence rate as measured by a modified Brief Adherence Rating Scale
Time frame: Through completion of study (estimated to be 3 months)
Results and safety
The study was stopped early (reason given: Principal Investigator left the university). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 37380519Silberstein AE, Fiala MA, Loh KP, Cordner T, Mian H, Wildes TM. A pilot study of adherence to lenalidomide among older patients with multiple myeloma. J Geriatr Oncol. 2023 Sep;14(7):101560. doi: 10.1016/j.jgo.2023.101560. Epub 2023 Jun 27. No abstract available.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Mark A Fiala, MSW principal investigator
Washington University School of Medicine
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 Washington University School of Medicine at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 22 Oct 2020. 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 United States. 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 was stopped early (reason given: Principal Investigator left the university). Results are not available in the source record.
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?
Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open (time frame: Through completion of study (estimated to be 3 months)). 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 NCT03779555, 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 Oct 2020.