Status:
UNKNOWN
Trial of Oral Lenalidomide Stewardship Program for Veterans
Lead Sponsor:
W.G. Bill Hefner Medical Center
Conditions:
Medication Compliance
Eligibility:
All Genders
Phase:
NA
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 lenalid...
Eligibility Criteria
Inclusion
- 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
- \< 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.
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 26 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04835220
Start Date
March 26 2021
End Date
March 26 2024
Last Update
February 28 2023
Active Locations (1)
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1
W.G. Bill Hefner VAMC
Salisbury, North Carolina, United States, 28144