Multiple MyelomaMEDULLANCT04314752
Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities
An observational study of Multiple Myeloma, run by University of California, Davis at 1 site in United States.
Trial summary
The objectives of the proposed study are to develop and evaluate protocols for ethnic/racial minority-specific research using cancer registry data. In conjunction with the Cancer Registry of Greater California (CRGC), the investigators have developed procedures to identify, recruit, and survey ethnic/racial minority… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 30 Dec 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We will recruit 4,000 participants (1000 Latinos/ 1000 African Americans/ 1000 Asian American/Native Hawaiian/Pacific Islanders/ 1000 Non-Hispanic Whites). Participants will be randomly selected from cancer registry using the criteria above.
Who may be able to join
- Diagnosed with a first primary pathologically confirmed case of Multiple Myeloma within the previous 5 years
- At least 21 years of age at the time of diagnosis
- Must have been diagnosed in one of the 48 counties in California
- Participant must be alive
- Identify as one of the following: African American, Latino, Asian American/Native Hawaiian/Pacific Islander, Non-Hispanic White
Who cannot join
- People who have not been diagnosed with Multiple Myeloma
- Under the age of 21
- Pregnant
- Prisoner
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
Luis Carvajal-Carmona, PhD, 530-752-9654, lgcarvajal@ucdavis.edu
Angelica Perez, BS, 9167344563, amiperez@ucdavis.edu
About this study
The objectives of the proposed study are to develop and evaluate protocols for ethnic/racial minority-specific research using cancer registry data. In conjunction with the Cancer Registry of Greater California (CRGC), the investigators have developed procedures to identify, recruit, and survey ethnic/racial minority patients with MM. To pilot the study, the investigators aim initially to test the feasibility of this protocol by contacting 400 eligible patients (100 African Americans, 100 Latinos, 100 Asian American/Native Hawaiian/Pacific Islander-AANHPI and 100 non-Hispanic Whites as a comparison group) to conduct a pilot survey through which will ascertain etiological and survival-related factors for MM. Ultimately, the investigators hope the findings from this pilot will yield insight into the best practices for recruiting minorities with MM and serve as the basis for larger population-based studies of MM etiology and survival.
The next phase of this study is to expand the study to all 3 California Cancer Registries, including the Greater Bay Area Cancer Registry and the Los Angeles Cancer Surveillance Program and Cancer Registry of Greater California. We will increase the sample size to recruit atleast 1000 participants per racial/ethnic group. We will also request to increase the scope of the study to also continue a survivorship cohort.
Read the detailed description
Eligible patients will include AAs, Latinos and AANHPIs who were diagnosed with a first primary, pathologically confirmed MM within the previous five years and who were at least 21 years of age at the time of diagnosis. We will also include, as a comparison group, non-Hispanic White patients. Patients must have been diagnosed in one of counties of California. Patients must be alive at the time of study and able to provide informed consent. We will not include those who are unable to consent, pregnant women, or prisoners.
Initially, in the pilot phase, we randomly selected 100 eligible patients from each race/ethnicity mentioned above to participate in the pilot study. As the pilot has been completed, we now aim to contact at recruit 1,000 patients per race/ethnic group reported to all three population cancer registries in the state, including the Greater Bay Area Cancer Registry and the Los Angeles Cancer Surveillance Program and Cancer Registry of Greater California until 2025. Patients diagnosis dates for the next phase of the study (June 2021-May 2025) will include diagnosis dates from 2018-2023, as there is a 2 year lag between patients cancer diagnosis and cancer registries information recorded.
Drs. Carvajal-Carmona and Cress have coordinated with MEDULLA investigators and CRGC research staff to develop a questionnaire for racial/ethnic minorities with Multiple Myeloma. The survey focuses on demographics, risk factors, cancer treatment, quality of life, and social determinants of health. All survey items are adapted from previously tested and validated surveys. The survey is expected to take approximately 30-45 minutes to complete.
CRGC staff, under Dr. Cress supervision, will identify eligible participants using the criteria described above based on diagnostic information in the CRGC database. The research team will be following California Cancer Registry policies and procedures for release of data. CRGC staff will extract patients contact information from the registry and will provide this information to research staff at UC Davis, who will work under Dr. Carvajal-Carmona's supervision.
The UC Davis Research team will initially mail each eligible participants a postcard and a survey study packet that will include: 1) Simple instruction sheet 2) An introductory letter that details the study 3) Information sheet that details on informed consent 4) Survey instruction sheet 5) A paper copy of the survey 5) Incentive selection sheet and option to continue to the second part of study 6) Brochures about the cancer registry and the UC Davis Comprehensive Cancer Center, and return pre-paid envelope.
- Conditions
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
Review the response rate of mailed out surveys, compared by race/ethnicity and disease status
Response Rate in percentage
Measured: 2025
Response rate for saliva kits compared to survey response and determine if there is a disparity in participation between race/ethnic groups
Response Rates in percentage
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2020
- Study start1 Sep 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 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 University of California, DavisThe 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-control
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Registry of Greater California
- Responsible party
- Sponsor
- Investigators
- Luis Carvajal-Carmona, PhD, Principal investigator, University of California, DavisRosemary Cress, DrPh MPH, Principal investigator, Cancer Registry of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04314752
- Sponsor's protocol ID
- 1487154
- Acronym
- MEDULLA
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once everything is de-identified, we may share data or genetic information with dbGaP, a database of genotypes and phenotypes through the NIH for additional research. Protocols for additional research will be submitted to IRB for approval before use of this data or genetic information.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities
- ClinicalTrials.gov ID
- NCT04314752
- Acronym / sponsor ID
- MEDULLA / 1487154
- Conditions
- Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Cancer Registry of Greater California
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Mar 2020 (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.
The objectives of the proposed study are to develop and evaluate protocols for ethnic/racial minority-specific research using cancer registry data. In conjunction with the Cancer Registry of Greater California (CRGC), the investigators have developed procedures to identify, recruit, and survey ethnic/racial minority patients with MM. To pilot the study, the investigators aim initially to test the feasibility of this protocol by contacting 400 eligible patients (100 African Americans, 100 Latinos, 100 Asian American/Native Hawaiian/Pacific Islander-AANHPI and 100 non-Hispanic Whites as a comparison group) to conduct a pilot survey through which will ascertain etiological and survival-related factors for MM. Ultimately, the investigators hope the findings from this pilot will yield insight into the best practices for recruiting minorities with MM and serve as the basis for larger population-based studies of MM etiology and survival.
The next phase of this study is to expand the study to all 3 California Cancer Registries, including the Greater Bay Area Cancer Registry and the Los Angeles Cancer Surveillance Program and Cancer Registry of Greater California. We will increase the sample size to recruit atleast 1000 participants per racial/ethnic group. We will also request to increase the scope of the study to also continue a survivorship cohort.
Detailed description
Eligible patients will include AAs, Latinos and AANHPIs who were diagnosed with a first primary, pathologically confirmed MM within the previous five years and who were at least 21 years of age at the time of diagnosis. We will also include, as a comparison group, non-Hispanic White patients. Patients must have been diagnosed in one of counties of California. Patients must be alive at the time of study and able to provide informed consent. We will not include those who are unable to consent, pregnant women, or prisoners.
Initially, in the pilot phase, we randomly selected 100 eligible patients from each race/ethnicity mentioned above to participate in the pilot study. As the pilot has been completed, we now aim to contact at recruit 1,000 patients per race/ethnic group reported to all three population cancer registries in the state, including the Greater Bay Area Cancer Registry and the Los Angeles Cancer Surveillance Program and Cancer Registry of Greater California until 2025. Patients diagnosis dates for the next phase of the study (June 2021-May 2025) will include diagnosis dates from 2018-2023, as there is a 2 year lag between patients cancer diagnosis and cancer registries information recorded.
Drs. Carvajal-Carmona and Cress have coordinated with MEDULLA investigators and CRGC research staff to develop a questionnaire for racial/ethnic minorities with Multiple Myeloma. The survey focuses on demographics, risk factors, cancer treatment, quality of life, and social determinants of health. All survey items are adapted from previously tested and validated surveys. The survey is expected to take approximately 30-45 minutes to complete.
CRGC staff, under Dr. Cress supervision, will identify eligible participants using the criteria described above based on diagnostic information in the CRGC database. The research team will be following California Cancer Registry policies and procedures for release of data. CRGC staff will extract patients contact information from the registry and will provide this information to research staff at UC Davis, who will work under Dr. Carvajal-Carmona's supervision.
The UC Davis Research team will initially mail each eligible participants a postcard and a survey study packet that will include: 1) Simple instruction sheet 2) An introductory letter that details the study 3) Information sheet that details on informed consent 4) Survey instruction sheet 5) A paper copy of the survey 5) Incentive selection sheet and option to continue to the second part of study 6) Brochures about the cancer registry and the UC Davis Comprehensive Cancer Center, and return pre-paid envelope.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit 4,000 participants (1000 Latinos/ 1000 African Americans/ 1000 Asian American/Native Hawaiian/Pacific Islanders/ 1000 Non-Hispanic Whites). Participants will be randomly selected from cancer registry using the criteria above.
Key inclusion criteria (5 listed)
- Diagnosed with a first primary pathologically confirmed case of Multiple Myeloma within the previous 5 years
- At least 21 years of age at the time of diagnosis
- Must have been diagnosed in one of the 48 counties in California
- Participant must be alive
- Identify as one of the following: African American, Latino, Asian American/Native Hawaiian/Pacific Islander, Non-Hispanic White
Key exclusion criteria (4 listed)
- People who have not been diagnosed with Multiple Myeloma
- Under the age of 21
- Pregnant
- Prisoner
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
Review the response rate of mailed out surveys, compared by race/ethnicity and disease status
Time frame: 2025
Response Rate in percentage
Response rate for saliva kits compared to survey response and determine if there is a disparity in participation between race/ethnic groups
Time frame: 2025
Response Rates in percentage
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 14 Sep 2026.
- Individual participant dataSharing planned: No. Once everything is de-identified, we may share data or genetic information with dbGaP, a database of genotypes and phenotypes through the NIH for additional research. Protocols for additional research will be submitted to IRB for approval before use of this data or genetic information.
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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.
Luis Carvajal-Carmona, PhD principal investigator
University of California, Davis
Rosemary Cress, DrPh MPH principal investigator
Cancer Registry of California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by University of California, Davis 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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Sep 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?
Contact Luis Carvajal-Carmona, PhD (5307529654, lgcarvajal@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Review the response rate of mailed out surveys, compared by race/ethnicity and disease status (time frame: 2025). 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?
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 14 Sep 2026.