Multiple MyelomaNCT05860179
Examination of Trends in Multiple Myeloma Trial Patient Experiences
An observational study of Multiple Myeloma, run by Power Life Sciences Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- May 2024to May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Multiple myeloma patients who are actively considering enrolling in a medical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Analyzing Factors of Patient Involvement in Multiple Myeloma Clinical Trials
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
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with multiple myeloma who decide to enroll in clinical trial
Measured: 3 Months
Rate of patients with multiple myeloma who remain in clinical trial to completion
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study startMay 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05860179
- Sponsor's protocol ID
- 80736578
- Status last verified
- Apr 2023
- First submitted
- 21 Apr 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34465728Goldschmidt H. [Clinical update-multiple myeloma]. Radiologe. 2022 Jan;62(1):3-11. doi: 10.1007/s00117-021-00941-0. Epub 2021 Dec 30. German.
PubMed 34967910Efficace 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.
PubMed 35183476
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analyzing Factors of Patient Involvement in Multiple Myeloma Clinical Trials
- ClinicalTrials.gov ID
- NCT05860179
- Acronym / sponsor ID
- 80736578
- Conditions
- Multiple Myeloma
- Keywords
- multiple myeloma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- May 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 16 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple myeloma patients who are actively considering enrolling in a medical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with multiple myeloma who decide to enroll in clinical trial
Time frame: 3 Months
Rate of patients with multiple myeloma who remain in clinical trial to completion
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 34465728Fernandes 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.
- Background: PubMed 34967910Goldschmidt H. [Clinical update-multiple myeloma]. Radiologe. 2022 Jan;62(1):3-11. doi: 10.1007/s00117-021-00941-0. Epub 2021 Dec 30. German.
- Background: PubMed 35183476Efficace 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Power Life Sciences Inc..
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 3 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: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (415-900-4227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with multiple myeloma who decide to enroll in clinical trial (time frame: 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 NCT05860179, which also lists 3 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 23 May 2023.