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NCT05053607 · ClinicalTrials.gov registry record · NA
Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab
A NA study of Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Pack Health.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 2
- Study locations
NCT05053607 is a NA study of Multiple Myeloma and Refractory Multiple Myeloma that is actively recruiting participants, run by Pack Health. The registered enrollment target is 50 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05053607, a NA study of Multiple Myeloma and Refractory Multiple Myeloma, is actively recruiting participants, sponsored by Pack Health.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 2
- Study locations
Study Summary
This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument. Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing
Conditions Studied
Interventions
- DEVICE Fitbit
- BEHAVIORAL Digital Health Coaching Program
Study Locations (2)
Texas
- The University of Texas MD Anderson Cancer Center - Houston
Washington
- University of Washington - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-06-17 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05053607
The ClinicalTrials.gov registry entry for NCT05053607 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower). The listed sponsor is Pack Health, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Multiple Myeloma appearing as the primary indexed condition, and to 2 interventions - of which Fitbit is the first listed.
NCT05053607 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT05053607 about?
NCT05053607 is a clinical study titled "Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab". This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of ...
What is the current status of trial NCT05053607?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2022-06-17. Estimated completion is 2025-12-31.
What conditions does trial NCT05053607 study?
This clinical trial studies the following conditions: Multiple Myeloma, Refractory Multiple Myeloma.
What interventions are being tested in trial NCT05053607?
The interventions under investigation include: Fitbit (DEVICE), Digital Health Coaching Program (BEHAVIORAL).
Who is sponsoring clinical trial NCT05053607?
This trial is sponsored by Pack Health, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05053607 being conducted?
This trial has 2 study locations across Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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