A Study to Compare Subcutaneous Daratumumab with Intravenous Daratumumab
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: 20-009362
Sponsor Protocol Number: 20-009362
About this study
The purpose of this study is to evaluate qualtiy of life (QOL) metrics while receiving subcutaneous (SQ) daratumumab, patient satisfaction, and patient preference for IV and/or SC therapies.
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 - Registration:
- Age ≥ 18 years old.
- Diagnosis of multiple myeloma who have not received more than 3 lines of therapy.
- Currently on treatment with a daratumumab containing combination.
- Have received at least 4 doses of daratumumab.
- Intent to convert to SC version of daratumumab.
- Provide written informed consent.
- Ability to complete questionnaire(s) by themselves or with assistance.
Exclusion Criteria - Registration:
- Individuals < 18 years old.
- Last dose of IV dara received > 90 days prior to day of questionnaire administration.
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Shaji Kumar, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available