Clinical trial NCT04835220: Trial of Oral Lenalidomide Stewardship Program for Veterans
Official title: Trial of Oral Lenalidomide Stewardship Program for Veterans
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Medication Compliance
Lead sponsor: W.G. Bill Hefner Medical Center
Sponsor class: FED
First posted: 2021-04-08
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Telehealth intervention group and a control group.
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

* 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.

Exclusion Criteria:

* \< 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.

Primary outcomes:
measure: Adherence of medication compliance
timeFrame: 12 Months
Secondary outcomes:
measure: Clinical Characteristics
timeFrame: 12 months
Other outcomes:
Locations:
city: Salisbury
country: United States
facility: W.G. Bill Hefner VAMC
state: North Carolina
Study officials:
References: