Multiple MyelomaNCT05831358
Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program
A study testing Multiple Myeloma M-Protein Analysis and Multiple Myeloma Knowledge Questionnaires in people with Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
This project will pilot the expansion of the existing Taussig Outreach Program's community outreach and patient navigation model to study the multiple myeloma (MM) screening program. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- What is being tested?
- Multiple Myeloma M-Protein Analysis and Multiple Myeloma Knowledge Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2023to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant self-identifying as, or perceived as, Black and/or African-American
- 50 years of age or older
Who cannot join
- Participants who do not self-identify as Black and/or African American
- Under the age of 50 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
This project will pilot the expansion of the existing Taussig Outreach Program's community outreach and patient navigation model to study the multiple myeloma (MM) screening program. This involves analyzing community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This study also aims to gauge the current and general understanding of MM. This study seeks to recruit participants in the pilot screening program to promote early detection. Participants who have abnormal results will receive patient navigation for further diagnostics and testing.
Read the detailed description
Multiple Myeloma (MM) is a hematologic cancer of antibody-producing plasma cells. Multiple Myeloma is always preceded by a pre-malignant condition called monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma. Despite multiple therapeutic advances, there remains no cure for multiple myeloma. The disease is treated and monitored throughout a person's lifetime. This is why screening for early detection of this disease is important; however, MGUS and smoldering multiple myeloma are only diagnosed when they are found incidentally on labs during tests for unrelated symptoms. There are no current universal screening guidelines for MM. Among those who may benefit from MM screenings include African American/Black individuals, as it is twice as common in this population compared to Caucasian/White individuals. This study aims to develop a screening program specifically targeting underserved African American/Black individuals. This project will expand the existing Taussig Community Outreach screening program to include screening for multiple myeloma.
- Conditions
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- Being tested
- Multiple Myeloma M-Protein Analysis, Multiple Myeloma Knowledge Questionnaires
- Medical subject headings
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Myeloma M-Protein AnalysisOther
Participants will be screened with a blood test for monoclonal protein analysis
Multiple Myeloma Knowledge QuestionnairesOther
Participants will complete two questionnaires to share their attitudes toward their screening experience and completion of knowledge questions to gauge community reception and participant multiple myeloma knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Myeloma Screening Experience | Experimental | Participants will partake in a multiple myeloma screening program. The screening involves a blood sample and the completion of a questionnaire to gauge participants' multiple myeloma knowledge. Receives: Other: Multiple Myeloma M-Protein Analysis; Other: Multiple Myeloma Knowledge Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM
The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by the overall community reception of this screening being offered.
Measured: 12 months
To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM
The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by participant questionnaires detailing their attitudes toward, and experience, of the screening.
Measured: 12 months
To study participant knowledge of Multiple Myeloma
Participants will gain knowledge about Multiple Myeloma from the time of the screening to the time of follow-up one week or more after the screening. This will be measured by examining the difference in participant post-screening questionnaire results.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start16 Jun 2023
- Primary completion31 Dec 2024
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Not a randomized trial; use of convenience sampling.
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Valent, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831358
- Sponsor's protocol ID
- CASE1A23
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2023
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Multiple Myeloma to Fight Cancer Disparities: A Screening and Patient Navigation Program
- ClinicalTrials.gov ID
- NCT05831358
- Acronym / sponsor ID
- CASE1A23
- Conditions
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Apr 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.
This project will pilot the expansion of the existing Taussig Outreach Program's community outreach and patient navigation model to study the multiple myeloma (MM) screening program. This involves analyzing community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This study also aims to gauge the current and general understanding of MM. This study seeks to recruit participants in the pilot screening program to promote early detection. Participants who have abnormal results will receive patient navigation for further diagnostics and testing.
Detailed description
Multiple Myeloma (MM) is a hematologic cancer of antibody-producing plasma cells. Multiple Myeloma is always preceded by a pre-malignant condition called monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma. Despite multiple therapeutic advances, there remains no cure for multiple myeloma. The disease is treated and monitored throughout a person's lifetime. This is why screening for early detection of this disease is important; however, MGUS and smoldering multiple myeloma are only diagnosed when they are found incidentally on labs during tests for unrelated symptoms. There are no current universal screening guidelines for MM. Among those who may benefit from MM screenings include African American/Black individuals, as it is twice as common in this population compared to Caucasian/White individuals. This study aims to develop a screening program specifically targeting underserved African American/Black individuals. This project will expand the existing Taussig Community Outreach screening program to include screening for multiple myeloma.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Not a randomized trial; use of convenience sampling.
| Arm | Type | Receives |
|---|---|---|
| Multiple Myeloma Screening Experience | Experimental | Other: Multiple Myeloma M-Protein Analysis, Other: Multiple Myeloma Knowledge QuestionnairesParticipants will partake in a multiple myeloma screening program. The screening involves a blood sample and the completion of a questionnaire to gauge participants' multiple myeloma knowledge. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participant self-identifying as, or perceived as, Black and/or African-American
- 50 years of age or older
Key exclusion criteria (2 listed)
- Participants who do not self-identify as Black and/or African American
- Under the age of 50 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple Myeloma M-Protein AnalysisParticipants will be screened with a blood test for monoclonal protein analysis | Other | Multiple Myeloma Screening Experience |
| Multiple Myeloma Knowledge QuestionnairesParticipants will complete two questionnaires to share their attitudes toward their screening experience and completion of knowledge questions to gauge community reception and participant multiple myeloma knowledge. | Other | Multiple Myeloma Screening Experience |
Primary outcome
To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM
Time frame: 12 months
The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by the overall community reception of this screening being offered.
To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM
Time frame: 12 months
The goal is to leverage the existing model of community outreach and patient navigation to study the MM screening program, including community reception, screening program methods, reasons patients decided to participate, reasons patients declined participation, and participant views and attitudes. This will be measured by participant questionnaires detailing their attitudes toward, and experience, of the screening.
To study participant knowledge of Multiple Myeloma
Time frame: 12 months
Participants will gain knowledge about Multiple Myeloma from the time of the screening to the time of follow-up one week or more after the screening. This will be measured by examining the difference in participant post-screening questionnaire results.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
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.
Jason Valent, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiple Myeloma M-Protein Analysis and Multiple Myeloma Knowledge Questionnaires in people with Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance, run by Case Comprehensive Cancer Center at 1 site in United States.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To conduct and evaluate a study that incorporates patient navigation programs to recruit and screen participants for Multiple Myeloma and its disease precursors, MGUS or smoldering MM (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.