Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Pack Health.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
A 6-item survey assessing experience of a drug during clinical trial. The instrument consists of 3-free text and 3 scaled responses assessing the perceived benefits and disadvantages of received treatment and willingness to continue on drug after the study.
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 |
What NCT05053607 shows while recruiting
NCT05053607 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05053607's enrollment target sits among peer trials
50 252nd of 438 higher than 173 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)
RECRUITING · NA
-
An AI-Generated, Personalized Question Prompt List Intervention for Patients With Hematologic Cancers
RECRUITING · NA
-
Prehabilitation Exercise Training in Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
RECRUITING · NA
-
Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)
RECRUITING · NA
-
Study Using Prebiotics to Improve Gut Microbiome Diversity After Autologous Stem Cell Transplantation
RECRUITING · NA
-
Prehabilitation Feasibility Among Older Adults Undergoing Transplantation
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00200889 · 50 participants · Early Phase 1
Mapping Auricular Vagus Nerve Circuitry
- NCT00409435 · 50 participants · Phase 2
A Study of Pyridostigmine in Postural Tachycardia Syndrome
- NCT01202305 · 50 participants
The Use of Lymph Node Biopsies to Support HIV Pathogenesis Studies
- NCT01225913 · 50 participants · Phase 4
Mechanism(s) of Airflow Limitation During Exacerbation of Asthma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI