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Immunomodulatory Agent

Telehealth Calls for Medication Adherence

N/A

Waitlist Available

Research Sponsored by W.G. Bill Hefner Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Newly diagnosed with myeloma or initiating lenalidomide maintenance therapy after transplant or transplant ineligible patients that are started on lenalidomide until progression or intolerance

Renal function assessed by calculated creatinine clearance ≥ 30ml/min by Cockcroft-Gault formula

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing a new way to make sure people with cancer take their medicine. The study will test if this new way increases how often people take their medicine as prescribed.

Who is the study for?

This trial is for veterans newly diagnosed with myeloma or those starting on lenalidomide maintenance therapy. Participants must be able to take blood thinners, have certain liver and kidney function levels, not be pregnant, and comply with the Revlimid REMS program. They need internet access and a prescription for lenalidomide.Check my eligibility

What is being tested?

The study tests a telehealth stewardship program aimed at improving how well veterans stick to their oral chemotherapy regimen with lenalidomide. It involves regular telehealth calls as part of a team-based approach to manage medication adherence effectively.See study design

What are the potential side effects?

While the trial focuses on adherence rather than side effects, lenalidomide can cause blood clots, which is why anticoagulants are required. Other potential side effects include fatigue, diarrhea, rash or itching.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am newly diagnosed with myeloma or starting lenalidomide after a transplant or because I can't have a transplant.

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My kidneys work well enough, with a creatinine clearance rate of at least 30ml/min.

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I am registered and agree to follow the Revlimid REMS program requirements.

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I am prescribed lenalidomide.

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I am being treated with lenalidomide for newly diagnosed myeloma.

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I have been diagnosed with myeloma.

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I can take blood thinners like aspirin or warfarin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence of medication compliance

Secondary outcome measures

Clinical Characteristics

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth intervention groupExperimental Treatment1 Intervention

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).

Group II: Control GroupActive Control1 Intervention

Electronic pill bottle cap (MEMs bottle cap) with no Telehealth calls

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

W.G. Bill Hefner Medical CenterLead Sponsor

1 Previous Clinical Trials

500 Total Patients Enrolled

Media Library

Lenalidomide (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04835220 — N/A

Medication Adherence Research Study Groups: Control Group, Telehealth intervention group

Medication Adherence Clinical Trial 2023: Lenalidomide Highlights & Side Effects. Trial Name: NCT04835220 — N/A

Lenalidomide (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04835220 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollment opportunities for this clinical research?

"The information found on clinicaltrials.gov suggests that this trial is not currently seeking participants, having been first posted on March 26th 2021 and last edited the following month. However, there are presently six other studies enrolling patients at this moment in time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trial of Oral Lenalidomide Stewardship Program for Veterans

Michael Goodman 2021. "Trial of Oral Lenalidomide Stewardship Program for Veterans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04835220.