Multiple Myeloma Clinical Trial
Official title:
Analyzing Factors of Patient Involvement in Multiple Myeloma Clinical Trials
| NCT number | NCT05860179 |
| Other study ID # | 80736578 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2024 |
| Est. completion date | May 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | May 2026 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with multiple myeloma who decide to enroll in clinical trial | 3 Months | ||
| Primary | Rate of patients with multiple myeloma who remain in clinical trial to completion | 12 month |
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