Impact Of Restricted Medication Access On Care Of Multiple Myeloma Patients
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-010911
Sponsor Protocol Number: 23-010911
About this study
The purpose of this study is to evaluate differences in time to fill lenalidomide, pomalidomide and thalidomide (iMiDs) prescribed by a health-system provider (HSP) when the health-system specialty pharmacy is either 1) in both the limited distribution (LDD) network and payor network, 2) in the LDD network but payor lock out, or 3) not in the LDD network. To accomplish this aim, we will perform a mixed methods study using quantitative data to evaluate time to medication access and qualitative data using surveys to assess patient and provider experiences.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Eighteen (18) years or older.
- Active diagnosis of multiple myeloma.
- Newly started on lenalidomide, pomalidomide or thalidomide by a Cedars-Sinai provider:
- “Newly started” is defined as patients without a previous prescription written for the respective iMiD on the EMR documentation system in the last 12 months.
Exclusion Criteria:
- Prescriptions dispensed at a third party specialty pharmacy that is contracted with the participating medical center to dispense thalidomide, lenalidomide or pomalidomide.
- Prescriptions initiated by a non-Mayo Clinic provider or if the original prescription was not found in the electronic health record.
- Patients who were initiated on therapy during inpatient stay.
- Patients who were initiated on therapy as part of a clinical trial.
- Patients with records flagged “break the glass” or “research opt out.”
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 10/25/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Tyler Sandahl, Pharm.D., R.Ph., BCOP |
Open for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available