Examination of Trends in Multiple Myeloma Trial Patient Experiences

NCT05860179 | Not Yet Recruiting

• 1 other identifier: 80736578
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future multiple myeloma patients.

Conditions

Multiple Myeloma

Keywords

multiple myeloma

Outcome Measures

Primary Outcomes (2)

• Number of participants with multiple myeloma who decide to enroll in clinical trial

  3 Months

• Rate of patients with multiple myeloma who remain in clinical trial to completion

  12 month

Eligibility Criteria

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

Study Population

Multiple myeloma patients who are actively considering enrolling in a medical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
• Patient has been diagnosed with multiple myeloma
• Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

You may not qualify if:

• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form
• Pregnant, breastfeeding or expecting to conceive within the projected duration of the study

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Fernandes LL, Zhou J, Kanapuru B, Horodniceanu E, Gwise T, Kluetz PG, Bhatnagar V. Review of patient-reported outcomes in multiple myeloma registrational trials: highlighting areas for improvement. Blood Cancer J. 2021 Aug 31;11(8):148. doi: 10.1038/s41408-021-00543-y.

  PMID: 34465728 BACKGROUND

• Goldschmidt H. [Clinical update-multiple myeloma]. Radiologe. 2022 Jan;62(1):3-11. doi: 10.1007/s00117-021-00941-0. Epub 2021 Dec 30. German.

  PMID: 34967910 BACKGROUND

• Efficace F, Cottone F, Sparano F, Caocci G, Vignetti M, Chakraborty R. Patient-Reported Outcomes in Randomized Controlled Trials of Patients with Multiple Myeloma: A Systematic Literature Review of Studies Published Between 2014 and 2021. Clin Lymphoma Myeloma Leuk. 2022 Jul;22(7):442-459. doi: 10.1016/j.clml.2022.01.009. Epub 2022 Jan 19.

  PMID: 35183476 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

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 16, 2023
• Study Start: May 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: May 23, 2023

Record last verified: 2023-04