Medication ComplianceNCT04835220
Trial of Oral Lenalidomide Stewardship Program for Veterans
A study testing Telehealth Calls in people with Medication Compliance, run by W.G. Bill Hefner Medical Center at 1 site in United States.
Trial summary
To address the challenge of oral chemotherapy stewardship in the Veteran population, this study outlines the implementation and evaluation of a pilot program for the delivery and management of lenalidomide to increase the adherence rates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Compliance
- What is being tested?
- Telehealth Calls
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2021to 20 Jun 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
- Newly diagnosed with myeloma or Initiating lenalidomide maintenance therapy after transplant or transplant ineligible patients that are started on lenalidomide until progression or intolerance.
- Myeloma diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] codes:vC90.00 or associated diagnosis )
- Prescription for lenalidomide
- Planned or Currently treated with lenalidomide as part of a treatment regimen for newly diagnosed myeloma
- Renal function assessed by calculated creatinine clearance as follows (see Appendix: Cockcroft-Gault estimation of CrCl):
- Subjects must have calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula. (See Appendix C). Dosing for patients with creatinine clearance between 30ml/min-60ml/min will be based on lenalidomide package insert.
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- Total bilirubin 1.5 x ULN
- AST (SGOT) and ALT (SGPT) 3 x ULN.
- All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
- Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
- Able to take prophylactic anticoagulation such as aspirin, warfarin, low molecular weight heparin or direct oral anticoagulant.
- Personal Computer with internet Capability.
Who cannot join
- < 18 years of age as of the index date
- Newly diagnosed with myeloma and not started on lenalidomide
- Known hypersensitivity to thalidomide or lenalidomide (if applicable).
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
- Females who are pregnant.
Trial locations and contacts
1 site in 1 country.
United States1 site
W.G. Bill Hefner VAMC
Salisbury, North Carolina, 28144
About this study
To address the challenge of oral chemotherapy stewardship in the Veteran population, this study outlines the implementation and evaluation of a pilot program for the delivery and management of lenalidomide to increase the adherence rates. Our goal is to utilize a team-based multi-disciplinary approach using existing technological resources such as the tele-oncology program at the Salisbury VA and other VA medical centers to provide cancer care that is safe, effective, compassionate, and cost-effective. Subject will be prescribed a Lenalidomide based therapy per standard of care. Eligibility is based only on a prescription for Lenalidomide and is independent of any other concurrent treatments for myeloma. The objectives are as followed: 1. To describe the demographics and baseline clinical characteristics of veterans with newly diagnosed multiple myeloma treated with oral lenalidomide. 2. To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide.
- Conditions
- Medication Compliance
- Being tested
- Telehealth Calls
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth CallsOther
The telehealth nurse will record data in a case report form within the VA REDCap electronic data capture system that is stored within the VA firewall.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Electronic pill bottle cap (MEMs bottle cap) with no Telehealth calls |
| Telehealth intervention group | Other | Electronic pill bottle cap (MEMs bottle cap) with regular telehealth visits to the veterans at the VAMCs on the stewardship program. These visits will involve contacting the veterans by telephone, administering a questionnaire to review their medication-taking behavior for oral chemotherapy, and potentially contacting the treating oncologist in the event that the veterans are at risk of non-adherence (based on their responses). Receives: Other: Telehealth Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence of medication compliance
To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide. Adherence of veterans to their prescribed lenalidomide treatment will be measured based on MEMs bottle cap data. A descriptive analysis using data from the MGL Scale (asked during the telehealth call) will be conducted to describe adherence in the stewardship assistance program cohort. Of note, patients in the intervention arm who stop attending telehealth calls prior to the completion of the patient stewardship program will still be considered as part of the intervention arm (i.e., an "intent-to-treat analysis"). However, data on the participation in the patient stewardship program (e.g., number of telehealth visits attended), will be collected and may be used in sensitivity analyses if appropriate.
Measured: 12 Months
Secondary outcomes (1)
Clinical Characteristics
Describe the demographics and baseline clinical characteristics of veterans with newly diagnosed multiple myeloma treated with oral lenalidomide.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start26 Mar 2021
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Why it stopped: withdrawn due to funding and poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication ComplianceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Telehealth intervention group and a control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.G. Bill Hefner Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835220
- Sponsor's protocol ID
- 17-42
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2021
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Oral Lenalidomide Stewardship Program for Veterans
- ClinicalTrials.gov ID
- NCT04835220
- Acronym / sponsor ID
- 17-42
- Conditions
- Medication Compliance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: withdrawn due to funding and poor accrual
- Enrolment
- 40 participants (actual)
- Lead sponsor
- W.G. Bill Hefner Medical CenterUS federal agency
- Study start
- 26 Mar 2021 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 8 Apr 2021 (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 address the challenge of oral chemotherapy stewardship in the Veteran population, this study outlines the implementation and evaluation of a pilot program for the delivery and management of lenalidomide to increase the adherence rates. Our goal is to utilize a team-based multi-disciplinary approach using existing technological resources such as the tele-oncology program at the Salisbury VA and other VA medical centers to provide cancer care that is safe, effective, compassionate, and cost-effective. Subject will be prescribed a Lenalidomide based therapy per standard of care. Eligibility is based only on a prescription for Lenalidomide and is independent of any other concurrent treatments for myeloma. The objectives are as followed: 1. To describe the demographics and baseline clinical characteristics of veterans with newly diagnosed multiple myeloma treated with oral lenalidomide. 2. To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Telehealth intervention group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Electronic pill bottle cap (MEMs bottle cap) with no Telehealth calls |
| Telehealth intervention group | Other | Other: Telehealth CallsElectronic pill bottle cap (MEMs bottle cap) with regular telehealth visits to the veterans at the VAMCs on the stewardship program. These visits will involve contacting the veterans by telephone, administering a questionnaire to review their medication-taking behavior for oral chemotherapy, and potentially contacting the treating oncologist in the event that the veterans are at risk of non-adherence (based on their responses). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Newly diagnosed with myeloma or Initiating lenalidomide maintenance therapy after transplant or transplant ineligible patients that are started on lenalidomide until progression or intolerance.
- Myeloma diagnosis (International Classification of Diseases, Tenth Revision, Clinical Modification [ICD-10-CM] codes:vC90.00 or associated diagnosis )
- Prescription for lenalidomide
- Planned or Currently treated with lenalidomide as part of a treatment regimen for newly diagnosed myeloma
- Renal function assessed by calculated creatinine clearance as follows (see Appendix: Cockcroft-Gault estimation of CrCl):
Key exclusion criteria (6 listed)
- < 18 years of age as of the index date
- Newly diagnosed with myeloma and not started on lenalidomide
- Known hypersensitivity to thalidomide or lenalidomide (if applicable).
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
- Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible.
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 |
|---|---|---|
| Telehealth CallsThe telehealth nurse will record data in a case report form within the VA REDCap electronic data capture system that is stored within the VA firewall. | Other | Telehealth intervention group |
Primary outcome
Adherence of medication compliance
Time frame: 12 Months
To evaluate the impact of the stewardship program (intervention) on the adherence to oral lenalidomide. Adherence of veterans to their prescribed lenalidomide treatment will be measured based on MEMs bottle cap data. A descriptive analysis using data from the MGL Scale (asked during the telehealth call) will be conducted to describe adherence in the stewardship assistance program cohort. Of note, patients in the intervention arm who stop attending telehealth calls prior to the completion of the patient stewardship program will still be considered as part of the intervention arm (i.e., an "intent-to-treat analysis"). However, data on the participation in the patient stewardship program (e.g., number of telehealth visits attended), will be collected and may be used in sensitivity analyses if appropriate.
1 secondary outcome
Clinical Characteristics
Time frame: 12 months
Results and safety
The study was stopped early (reason given: withdrawn due to funding and poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth Calls in people with Medication Compliance, run by W.G. Bill Hefner Medical Center 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 12 inclusion and 6 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 2 Oct 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 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: withdrawn due to funding and poor accrual). 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 of medication compliance (time frame: 12 Months). 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 2 Oct 2026.