Clinical trial NCT05860179: Examination of Trends in Multiple Myeloma Trial Patient Experiences
Official title: Analyzing Factors of Patient Involvement in Multiple Myeloma Clinical Trials
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Myeloma
Keywords: multiple myeloma
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of participants with multiple myeloma who decide to enroll in clinical trial
timeFrame: 3 Months
measure: Rate of patients with multiple myeloma who remain in clinical trial to completion
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.