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Isatuximab for Multiple Myeloma
Study Summary
This trial will enroll 50 adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc to collect quantitative, qualitative, and wearable data on their treatment experience across 3 months.
- Multiple Myeloma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have been identified by your doctor as having 6 months or less to live, or you are receiving only supportive care without curative treatment.You are currently receiving isatuximab-irfc through subcutaneous injection.You have multiple myeloma that has come back after treatment or has not responded to treatment, and it matches the description given by the FDA for the use of isatuximab-irfc (Sarclisa®).You are able to do physical activities and have an ECOG performance status score of 2 or less.You have received or are planning to receive intravenous isatuximab-irfc for relapsed/refractory multiple myeloma. You can still participate if you are receiving other medications at the same time, such as pomalidomide.
- Group 1: 1. Single Arm Cohort Receiving Digital Health Coaching
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What is the cap on enrolment for this research study?
"Yes, the evidence on clinicaltrials.gov suggests that this experiment is currently recruiting individuals. It was first made available to potential participants on June 17th 2022 and has had its details updated as of the same date. A total of 50 subjects are required for participation from a single healthcare centre."
Are there any available slots in this research endeavor?
"The clinical trial is currently recruiting participants, as indicated by information on Clinicialtrials.gov. This medical study was initially posted June 17th 2022 and has been recently revised on the same date."
What is the ultimate purpose of this clinical trial?
"This medical trial intends to evaluate how participants perceive their treatment experience over a 3-month period through qualitative interviews. Additionally, the study will measure changes in the Quality of Life Questionnaire Multiple myeloma (QLQ-MY20), Patient Global Impression of Severity (PGIS) Scale, and Comprehensive Score for Financial Toxicity (COST) Instrument. The QLQ-MY20 is a 20 item survey scored on a 4 point Likert scale ranging from Not at All to Very Much; PGIS is assessed as 1 item with 5 possible responses; and COST has 11 items graded from 0 - Not at all"
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