AzTrials
AzTrials

Multiple MyelomaNCT05053607

Real World Insights During Treatment for Relapsed/Refractory Multiple Myeloma with Isatuximab

A study testing Digital Health Coaching Program and Fitbit in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Pack Health at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma, Refractory Multiple Myeloma
What is being tested?
Digital Health Coaching Program and Fitbit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
17 Jun 2022to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 or older
  • Diagnosis of relapsed/refractory multiple myeloma corresponding to the Food and Drug Administration (FDA) package insert for isatuximab-irfc (Sarclisa®).
  • 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.
  • Access to and willingness to use a smartphone or other device through which they can send and receive text messages, emails and/or access a mobile application.
  • Willingness to wear and have data collected by a Fitbit
  • Ability to engage in physical activity as evidenced by an Eastern Cooperative Oncology Group (ECOG) performance status score of less than or equal to 2

Who cannot join

  • Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
  • Individuals for whom there is documentation of inability to provide consent in the medical record.
  • Individuals receiving isatuximab-irfc subcutaneously

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kelly J Brassil, PhD contact

205-721-7542

dgxpharesearch@questdiagnostics.com

Jennifer Loftis, DNP contact

205-721-7542

dgxpharesearch@questdiagnostics.com

United States2 sites, 1 recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77074

    Active, not recruiting

  • University of Washington

    Seattle, Washington, 98109

    Trenton Grossfeld, BS, 206-606-1774, tgrossfeld@seattlecca.org

    Rahul Banerjee, MD

    Recruiting

Other trials in United States

About this study

Official title: Clinical and Patient Reported Outcomes for Individuals with Relapsed/Refractory Multiple Myeloma Treated with Isatuximab: Real-World Insights from Patient Reported, Wearable, and Qualitative Data in the Context of Digital Health Coaching

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 to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.

Being tested
Digital Health Coaching Program, Fitbit
Keywords
isatuximab, wearable electronic devices, qualitative research, patient reported outcome measures
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Health Coaching ProgramBehavioural

    consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.

  • FitbitDevice

    A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.

Study groups in NCT05053607
Study groupRoleWhat they receive
1. Single Arm Cohort Receiving Digital Health CoachingOtherAll 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.
Receives: Behavioral: Digital Health Coaching Program; Device: Fitbit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW)

    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.

    Measured: Change in baseline perception of treatment experience at 3 months

  2. Qualitative Interview

    A one time interview will be conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects and overall care experience.

    Measured: Within the last month of study participation

Secondary outcomes (8)

  1. Change in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30)

    A 30-item measure of quality of life across 5 domains, including physical, emotional, social, role and cognitive), 8 symptoms, and items assessing global health and financial toxicity. Recall over the past week is scored primarily on a 4-point scale ranging from "not at all" to "very much". The instrument may be administered either on paper or electronically.

    Measured: Change in baseline perception of treatment experience at 3 months

  2. Change in Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20)

    A 20-item measure of quality of life among individuals with multiple myeloma. It assesses a series of symptoms on a 4-point Likert scale ranging from 1 (Not at All) to 4 (Very Much).

    Measured: Change in baseline perception of treatment experience at 3 months

  3. Change in European QoL-5 Dimensions (EQ5D)

    A measure of quality of life across 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

    Measured: Change in baseline perception of treatment experience at 3 months

  4. Change in Cancer Behavior Inventory-Brief Form (CBI-B)

    This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".

    Measured: Change in baseline perception of treatment experience at 3 months

  5. Change in Patient Global Impression of Severity (PGIS) Scale

    A 1-item measure of severity of relapsed/refractory multiple myeloma symptoms since the last visit, which is scored a on a 5-response scale ranging from "none" to "very severe".

    Measured: Change in baseline perception of treatment experience at 3 months

  6. Change in Patient Global Impression of Change (PGIC) Scale

    A 1-item measure of patient perception of change in relapsed/refractory multiple myeloma symptoms since starting a study. Responses are scored on a 7-point scale, ranging from "very much worse" to "very much better".

    Measured: Change in baseline perception of treatment experience at 3 months

  7. Change in Center for Adherence Support Evaluation (CASE) Medication Adherence Index

    The Center for Adherence Support Evaluation (CASE) is a three-item questionnaire used to measure antiretroviral therapy adherence. This questionnaire was developed through the Special Projects of National Significance (SPNS) initiative called Assessing Existing Efforts to Increase Adherence to Medication. Patients take less than 5 minutes to answer the three unique questions, asking about their difficulty taking medications on time, average days per week with one dose missed, and the last time they missed a dose.

    Measured: Change in baseline perception of treatment experience at 3 months

  8. Change in Comprehensive Score for Financial Toxicity (COST) Instrument

    The Comprehensive Score for Financial Toxicity (COST) is an 11-item instrument used to measure the financial toxicity of cancer treatment, which has been demonstrated to be highly correlated with HRQoL (de Souza et al., 2017). This instrument was validated among individuals with advanced cancer and demonstrated high internal consistency (Cronbach's α >.90) and highly correlated to HRQol (p=.05). The instrument consists of 11 items, utilizing a five-point ordinal scale ranging from (0- Not at all) to (4- Very much).

    Measured: Change in baseline perception of treatment experience at 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2021
  2. Study start17 Jun 2022
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
A single cohort of 50 individuals with relapsed/refractory multiple myeloma will be enrolled in the study, all of which will be enrolled in a digital health coaching program and receive a Fitbit device for activity tracking. Individuals from both study sites will be enrolled to this single cohort.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05053607
Sponsor's protocol ID
2021-0309
Status last verified
Dec 2024
First submitted
7 Sep 2021
Last updated
11 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.

    PubMed 28586821

  • Cocks K, Cohen D, Wisloff F, Sezer O, Lee S, Hippe E, Gimsing P, Turesson I, Hajek R, Smith A, Graham L, Phillips A, Stead M, Velikova G, Brown J; EORTC Quality of Life Group. An international field study of the reliability and validity of a disease-specific questionnaire module (the QLQ-MY20) in assessing the quality of life of patients with multiple myeloma. Eur J Cancer. 2007 Jul;43(11):1670-8. doi: 10.1016/j.ejca.2007.04.022. Epub 2007 Jun 15.

    PubMed 17574838

  • de Souza JA, Yap BJ, Wroblewski K, Blinder V, Araujo FS, Hlubocky FJ, Nicholas LH, O'Connor JM, Brockstein B, Ratain MJ, Daugherty CK, Cella D. Measuring financial toxicity as a clinically relevant patient-reported outcome: The validation of the COmprehensive Score for financial Toxicity (COST). Cancer. 2017 Feb 1;123(3):476-484. doi: 10.1002/cncr.30369. Epub 2016 Oct 7.

    PubMed 27716900

  • Girault A, Ferrua M, Lalloue B, Sicotte C, Fourcade A, Yatim F, Hebert G, Di Palma M, Minvielle E. Internet-based technologies to improve cancer care coordination: current use and attitudes among cancer patients. Eur J Cancer. 2015 Mar;51(4):551-557. doi: 10.1016/j.ejca.2014.12.001. Epub 2015 Feb 4.

    PubMed 25661828

  • Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

    PubMed 18929686

  • Heitzmann CA, Merluzzi TV, Jean-Pierre P, Roscoe JA, Kirsh KL, Passik SD. Assessing self-efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI-B). Psychooncology. 2011 Mar;20(3):302-12. doi: 10.1002/pon.1735.

    PubMed 20878830

  • Kent EE, Ambs A, Mitchell SA, Clauser SB, Smith AW, Hays RD. Health-related quality of life in older adult survivors of selected cancers: data from the SEER-MHOS linkage. Cancer. 2015 Mar 1;121(5):758-65. doi: 10.1002/cncr.29119. Epub 2014 Nov 4.

    PubMed 25369293

  • Madduri D, Dhodapkar MV, Lonial S, Jagannath S, Cho HJ. SOHO State of the Art Updates and Next Questions: T-Cell-Directed Immune Therapies for Multiple Myeloma: Chimeric Antigen Receptor-Modified T Cells and Bispecific T-Cell-Engaging Agents. Clin Lymphoma Myeloma Leuk. 2019 Sep;19(9):537-544. doi: 10.1016/j.clml.2019.08.002. Epub 2019 Aug 7.

    PubMed 31427259

  • Madore S, Kilbourn K, Valverde P, Borrayo E, Raich P. Feasibility of a psychosocial and patient navigation intervention to improve access to treatment among underserved breast cancer patients. Support Care Cancer. 2014 Aug;22(8):2085-93. doi: 10.1007/s00520-014-2176-5. Epub 2014 Mar 18.

    PubMed 24639035

  • Mannheimer SB, Mukherjee R, Hirschhorn LR, Dougherty J, Celano SA, Ciccarone D, Graham KK, Mantell JE, Mundy LM, Eldred L, Botsko M, Finkelstein R. The CASE adherence index: A novel method for measuring adherence to antiretroviral therapy. AIDS Care. 2006 Oct;18(7):853-61. doi: 10.1080/09540120500465160.

    PubMed 16971298

  • Moreno L, Perez C, Zabaleta A, Manrique I, Alignani D, Ajona D, Blanco L, Lasa M, Maiso P, Rodriguez I, Garate S, Jelinek T, Segura V, Moreno C, Merino J, Rodriguez-Otero P, Panizo C, Prosper F, San-Miguel JF, Paiva B. The Mechanism of Action of the Anti-CD38 Monoclonal Antibody Isatuximab in Multiple Myeloma. Clin Cancer Res. 2019 May 15;25(10):3176-3187. doi: 10.1158/1078-0432.CCR-18-1597. Epub 2019 Jan 28.

    PubMed 30692097

  • Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, Burroughs H, Jinks C. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893-1907. doi: 10.1007/s11135-017-0574-8. Epub 2017 Sep 14.

    PubMed 29937585

  • Thorne S, Kirkham SR, MacDonald-Emes J. Interpretive description: a noncategorical qualitative alternative for developing nursing knowledge. Res Nurs Health. 1997 Apr;20(2):169-77. doi: 10.1002/(sici)1098-240x(199704)20:23.0.co;2-i.

    PubMed 9100747

  • Osoba D, Aaronson N, Zee B, Sprangers M, te Velde A. Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer. The Study Group on Quality of Life of the EORTC and the Symptom Control and Quality of Life Committees of the NCI of Canada Clinical Trials Group. Qual Life Res. 1997 Mar;6(2):103-8. doi: 10.1023/a:1026429831234.

    PubMed 9161109

  • Pearman TP, Beaumont JL, Mroczek D, O'Connor M, Cella D. Validity and usefulness of a single-item measure of patient-reported bother from side effects of cancer therapy. Cancer. 2018 Mar 1;124(5):991-997. doi: 10.1002/cncr.31133. Epub 2017 Nov 13.

    PubMed 29131323

Questions about this trial

What is this clinical trial studying?

A study testing Digital Health Coaching Program and Fitbit in people with Multiple Myeloma and Refractory Multiple Myeloma, run by Pack Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kelly J Brassil, PhD (205-721-7542, dgxpharesearch@questdiagnostics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient's Qualitative Assessment of Treatment Real World version (PQAT-RW) (time frame: Change in baseline perception of treatment experience at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05053607, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in