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

NCT05053607 | Recruiting

• 1 other identifier: 2021-0309
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Multiple Myeloma; Refractory Multiple Myeloma

Keywords

isatuximab; wearable electronic devices; qualitative research; patient reported outcome measures

Outcome Measures

Primary Outcomes (2)

• 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.

  Change in baseline perception of treatment experience at 3 months

• 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.

  Within the last month of study participation

Secondary Outcomes (8)

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

  Change in baseline perception of treatment experience at 3 months

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

  Change in baseline perception of treatment experience at 3 months

• Change in European QoL-5 Dimensions (EQ5D)

  Change in baseline perception of treatment experience at 3 months

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

  Change in baseline perception of treatment experience at 3 months

• Change in Patient Global Impression of Severity (PGIS) Scale

  Change in baseline perception of treatment experience at 3 months

Other Outcomes (3)

• Physical Activity

  From date of enrollment up to 3 months

• Health Care Utilization

  From date of enrollment up to 3 months

• Digital Engagement

  From date of enrollment up to 3 months

Study Arms (1)

1. Single Arm Cohort Receiving Digital Health Coaching

OTHER

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.

Behavioral: Digital Health Coaching Program; Device: Fitbit

Interventions

Digital Health Coaching Program BEHAVIORAL

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.

1. Single Arm Cohort Receiving Digital Health Coaching

Fitbit DEVICE

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.

1. Single Arm Cohort Receiving Digital Health Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pack Health: lead
• M.D. Anderson Cancer Center: collaborator
• Sanofi: collaborator
• University of Washington: collaborator

Study Sites (2)

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77074, United States

ACTIVE NOT RECRUITING

University of Washington

Seattle, Washington, 98109, United States

RECRUITING

Related Publications (19)

• 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.

  PMID: 28586821 BACKGROUND

• 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.

  PMID: 17574838 BACKGROUND

• 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.

  PMID: 27716900 BACKGROUND

• 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.

  PMID: 25661828 BACKGROUND

• 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.

  PMID: 18929686 BACKGROUND

• 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.

  PMID: 20878830 BACKGROUND

• 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.

  PMID: 25369293 BACKGROUND

• 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.

  PMID: 31427259 BACKGROUND

• 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.

  PMID: 24639035 BACKGROUND

• 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.

  PMID: 16971298 BACKGROUND

• 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.

  PMID: 30692097 BACKGROUND

• 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.

  PMID: 29937585 BACKGROUND

• 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.

  PMID: 9100747 BACKGROUND

• 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.

  PMID: 9161109 BACKGROUND

• 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.

  PMID: 29131323 BACKGROUND

• Proskorovsky I, Lewis P, Williams CD, Jordan K, Kyriakou C, Ishak J, Davies FE. Mapping EORTC QLQ-C30 and QLQ-MY20 to EQ-5D in patients with multiple myeloma. Health Qual Life Outcomes. 2014 Mar 11;12:35. doi: 10.1186/1477-7525-12-35.

  PMID: 24618388 BACKGROUND

• Ventura F, Ohlen J, Koinberg I. An integrative review of supportive e-health programs in cancer care. Eur J Oncol Nurs. 2013 Aug;17(4):498-507. doi: 10.1016/j.ejon.2012.10.007. Epub 2012 Nov 15.

  PMID: 23158437 BACKGROUND

• Zaleta AK, Miller MF, Olson JS, Yuen EYN, LeBlanc TW, Cole CE, McManus S, Buzaglo JS. Symptom Burden, Perceived Control, and Quality of Life Among Patients Living With Multiple Myeloma. J Natl Compr Canc Netw. 2020 Aug;18(8):1087-1095. doi: 10.6004/jnccn.2020.7561.

  PMID: 32755984 BACKGROUND

• Zhang T, Wang S, Lin T, Xie J, Zhao L, Liang Z, Li Y, Jiang J. Systematic review and meta-analysis of the efficacy and safety of novel monoclonal antibodies for treatment of relapsed/refractory multiple myeloma. Oncotarget. 2017 May 16;8(20):34001-34017. doi: 10.18632/oncotarget.16987.

  PMID: 28454113 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Melody R Becnel, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Rahul Banerjee, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kelly J Brassil, PhD

CONTACT

205-721-7542; dgxpharesearch@questdiagnostics.com

Jennifer Loftis, DNP

CONTACT

205-721-7542; dgxpharesearch@questdiagnostics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 22, 2021
• Study Start: June 17, 2022
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)