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

• ClinicalTrials.gov Identifier: NCT04314752
• Recruitment Status: Recruiting
• First Posted: March 19, 2020
• Last Update Posted: October 19, 2020
• Sponsor: University of California, Davis
• Collaborator: Cancer Registry of Greater California
• Information provided by (Responsible Party): University of California, Davis

Study Description

Brief 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 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.

Condition or disease
Multiple Myeloma

Detailed Description:

Eligible patients will include African Americans, 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. Investigators will also include, as a comparison group, non-Hispanic White patients. Patients must have been diagnosed in one of the 48 counties of California. Patients must be alive at the time of study and able to provide informed consent. The research team will not include those who are unable to consent, pregnant women, or prisoners.

Initially, investigators will randomly select 100 eligible patients from each race/ethnicity mentioned above to participate in the pilot study. Once the pilot is completed, the investigators will aim to contact all eligible patients reported to the Cancer Registry of Greater California (CRGC) until 2024.

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

• Study Type: Observational [Patient Registry]
• Estimated Enrollment: 400 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Target Follow-Up Duration: 4 Years
• Official Title: Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities
• Actual Study Start Date: September 1, 2020
• Estimated Primary Completion Date: November 30, 2024
• Estimated Study Completion Date: November 30, 2024

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Review the response rate of mailed out surveys, compared by race/ethnicity and disease status [ Time Frame: 2024 ]
   Response Rate in percentage
2. Response rate for saliva kits compared to survey response and determine if there is a disparity in participation between race/ethnic groups [ Time Frame: 2024 ]
   Response Rates in percentage

Biospecimen Retention:   Samples With DNA

Study team will collect 2ml of saliva from participants who consent to the biospecimen collection portion of the study. Saliva will be used for genetic and genomic research

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

100 Latinos 100 African American 100 Asian American/Native Hawaiian/Pacific Islander 100 Non-Hispanic White

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

Contacts and Locations

Contacts

Contact: Luis Carvajal-Carmona, PhD; 5307529654; lgcarvajal@ucdavis.edu

Contact: Fabian Perez, MPH; 9167344563; fpperez@ucdavis.edu

Locations

United States, California

University of California Davis Comprehensive Cancer Center; Recruiting

Sacramento, California, United States, 95817

Contact: Luis Carvajal-Carmona, PhD 530-752-9654 lgcarvajal@ucdavis.edu

Contact: Fabian Perez, MPH 9167344560 fpperez@ucdavis.edu

Sponsors and Collaborators

University of California, Davis

Cancer Registry of Greater California

Investigators

• Principal Investigator: Luis Carvajal-Carmona, PhD; University of California, Davis
• Principal Investigator: Rosemary Cress, DrPh MPH; Cancer Registry of California

  Study Documents (Full-Text)

Documents provided by University of California, Davis:

Study Protocol  [PDF] December 2, 2019

Informed Consent Form  [PDF] December 2, 2019

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT04314752
• Other Study ID Numbers: 1487154
• First Posted: March 19, 2020
• Last Update Posted: October 19, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases