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Monoclonal Antibodies

Isatuximab for Multiple Myeloma

N/A
Recruiting
Led By Rahul Banerjee, MD
Research Sponsored by Pack Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to engage in physical activity as evidenced by an ECOG performance status score of less than or equal to 2
Confirmed or planned treatment with intravenous isatuximab-irfc for relapsed/refractory multiple myeloma as standard-of-care therapy. Concurrent therapy with other agents (e.g., pomalidomide) is allowed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of enrollment up to 3 months
Awards & highlights

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.

Eligible Conditions
  • Multiple Myeloma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are able to do physical activities and have an ECOG performance status score of 2 or less.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within the last month of study participation
This trial's timeline: 3 weeks for screening, Varies for treatment, and within the last month of study participation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)
Qualitative Interview
Secondary outcome measures
Change in Cancer Behavior Inventory-Brief Form (CBI-B)
Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index
Change in Comprehensive Score for Financial Toxicity (COST) Instrument
+5 more
Other outcome measures
Digital Engagement
Health Care Utilization
Physical Activity

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1. Single Arm Cohort Receiving Digital Health CoachingExperimental Treatment2 Interventions
All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data. Participants have the option to participate in a one time interview about their treatment experience.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fitbit
2021
N/A
~3560

Find a Location

Who is running the clinical trial?

Pack HealthLead Sponsor
5 Previous Clinical Trials
1,118 Total Patients Enrolled
2 Trials studying Multiple Myeloma
150 Patients Enrolled for Multiple Myeloma
M.D. Anderson Cancer CenterOTHER
2,958 Previous Clinical Trials
1,798,415 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,787 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,158 Previous Clinical Trials
3,514,298 Total Patients Enrolled
46 Trials studying Multiple Myeloma
10,093 Patients Enrolled for Multiple Myeloma

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05053607 — N/A
Multiple Myeloma Research Study Groups: 1. Single Arm Cohort Receiving Digital Health Coaching
Multiple Myeloma Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT05053607 — N/A
Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05053607 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI
Recent research and studies
~18 spots leftby Mar 2025