Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 21 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - People who have not been diagnosed with Multiple Myeloma.
  • - Under the age of 21.
  • - Pregnant.
- Prisoner

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04314752
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of California, Davis
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Luis Carvajal-Carmona, PhDRosemary Cress, DrPh MPH
Principal Investigator Affiliation University of California, DavisCancer Registry of California
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Sacramento, California

Status

Recruiting

Address

University of California Davis Comprehensive Cancer Center

Sacramento, California, 95817

Site Contact

Luis Carvajal-Carmona, PhD

lgcarvajal@ucdavis.edu

530-752-9654