Development of a Research Infrastructure for Understanding and Addressing Multiple Myeloma Disparities
Conditions: Multiple Myeloma
Sponsor: University of California, Davis

PROTOCOL TITLE:Development of a research infrastructure for understanding and 
addressing multiple myeloma disparities 
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Development of a Research Infrastructure for Understanding and Addressing 
Multiple Myeloma Disparities 
 
[NCT Not Yet Assigned] 
December 2, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1) 
Protocol Title 
Title: Development of a research infrastructure for understanding and 
addressing multiple myeloma disparities 
Protocol Version Date: 12/02/2019 
2) 
Objectives   
 
• To develop sample selection, study materials, and protocols to recruit and 
survey ethnic/racial minority patients with multiple myeloma. 
• To evaluate the feasibility of using cancer registry data to identify and recruit a 
cohort of ethnic/racial minority patients diagnosed with multiple myeloma in 
California. 
• To evaluate the feasibility of surveying ethnic/racial minority patients with 
multiple myeloma to ascertain etiological and survival-related factors. 
• To better understand multiple myeloma etiology, survival, and to develop race-
appropriate multiple myeloma models 
 
3) 
Background 
 
Multiple myeloma (MM) is a malignancy of the plasma cells that accounts for 
nearly 13,000 deaths in the U.S. each year, representing 2.1% of all cancer deaths 
and 20% of all hematological malignancy deaths. Despite recent advances in 
treatment, such as the availability of immunomodulators and proteasome inhibitors, 
only about half of MM patients survive at least five years after diagnosis. MM is 
also associated with important disparities, with African Americans (AA) having 2- 
to 3-fold higher incidence and mortality rates than non-Hispanic Whites. The 
reasons for this disparity are unclear and indicate an important unmet need that 
should be addressed through AA-specific studies.  
 
To better understand MM etiology, survival, and to develop race-appropriate MM 
models, the Precision MEDicine, EqUity and Disparities Research in MultipLe 
MyeLomA (MEDULLA) Consortium was established. MEDULLA is based out of 
the five University of California (UC) Comprehensive Cancer Centers (Davis, Los 
Angeles, San Francisco, San Diego and San Francisco) and includes experts in 
cancer outcomes, disparities, and genetic etiological research. The long-term goal of 
MEDULLA is to identify and address the causes of MM disparities. 
 
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), we have developed 
procedures to identify, recruit, and survey ethnic/racial minority patients with MM. 
To pilot the study, we aim initially to test the feasibility of this protocol by 
contacting 400 eligible patients (100 AAs, 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 we will ascertain etiological and 
survival-related factors for MM. Ultimately, we hope the findings from this pilot 

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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.  
 
4) 
Inclusion and Exclusion Criteria 
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 the 48 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, we will randomly select 100 eligible patients from each 
race/ethnicity mentioned above to participate in the pilot study. Once the 
pilot is completed, we will aim to contact all eligible patients reported to the 
CRGC until 2024.  
5) 
Study Timelines 
This study will take place over five years (Dec. 2019 through Nov. 2024), 
and all analysis will be completed by the end of the study. 
Each participant will only be involved in the study for the time it takes to 
complete the survey and provide a biospecimen sample.  
6) 
Study Endpoints 
The study endpoint is the analysis of the information collected through the 
survey due to the funder by Nov. 2024.  
7) 
Procedures Involved 
 
This pilot study is being funded by the National Cancer Institute as an 
administrative supplement to the UC Davis Cancer Center Support Grant.  Drs. Luis 
Carvajal-Carmona and Rosemary Cress will co-lead this project. Dr. Carvajal-
Carmona is the lead of the MEDULLA Consortium. He is the Associate Director 
for Basic Science and the co-leader of the Population Sciences and Health 
Disparities Program at the UC Davis Comprehensive Cancer Center. Dr. Cress is an 
Adjunct Professor in the Department of Public Health Sciences at UC Davis as well 
as a Research Program Director with CRGC at the Public Health Institute (PHI).  
The CRGC is a grantee of the California Department of Public Health (CDPH) to 
collect cancer data for residents in its catchment area and is part of the California 
Cancer Registry. Dr. Cress will oversee all work by CRGC staff. 
 
Drs. Carvajal-Carmona and Cress have coordinated with MEDULLA investigators 
and CRGC research staff to develop a questionnaire for racial/ethnic minorities with 
MM. The survey (draft attached) focuses on demographics, risk factors, cancer 

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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. Final materials will be submitted to 
IRB before human subject contact is initiated.  
 
CRGC staff, under Dr. Cress supervision, will identify eligible participants using 
the criteria described above based on diagnostic information in the CRGC database. 
We will be following CCR 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. The following steps will be taken to follow 
up on the study packet mailing: 
 
1) If no response is received within two weeks of the mailing, research staff 
will follow up with non-respondent participants by telephone.  
a. If participant has received the post card and study packet, the 
research team will answer any additional questions they may have 
and ask to see if they will be participating in survey or remove them 
from the participant list. 
b. If participants has not received postcard and wishes to continue with 
the research study, a new study packet will be mailed. Correct 
Address will be confirmed. 
c. If participant is wanting to opt out, ask to see if they have received 
the packet, ask to see if they would like to take the survey over the 
phone. If not we will then remove them from the participant list. 
i. The study team will conduct the survey via telephone 
interview using the phone survey request script. In order to 
conduct survey over the phone, the research team will need to 
verify identity of participants and acquire their verbal consent 
before they can ask survey questions over the phone. 
Research team will also need to contact participant if their 
survey has been sent back incomplete.  
 
Once the first study packet is returned and completed, and the participant selected 
to continue participating in the second part of the study, a second study packet for 
biospecimen collection will be sent. The bio-specimen study packet will include 1) 
informed consent sheet 2)simple instruction sheet 3)saliva kit 4) incentive selection 
sheet and return pre-paid envelope. If the survey packet was returned and the 

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participant selected the opt out option for the bio-specimen study packet, the 
research team will do a final contact phone call to confirm their selection and 
answer any additional questions they may have. If they still wish to opt out,  we will 
then remove them from the participant list for the bio-specimen collection. 
 
Justification for Patient Contact: We plan to call patients two times if they fail to 
respond to the initial mailing. Additional mailings and phone calls are justified to 
explain the benefits of the study and enhance participation rates.  We will also do a 
check for survey completeness, and will follow up with patient if survey is not fully 
completed.  
 
For patients who consent to participate in the survey and  bio-specimen study, will 
be asked to consent. On the survey consent, the participant will be explained either 
verbally over the phone or in a letter attached to the survey that by completing this 
survey they are consenting to participate. For the saliva sample, a participant will 
have to sign a consent form that is included for the donation of 2ml of saliva, if the 
saliva is mailed back without the consent form, we will contact participant to send 
us back the form, once consent and saliva is received together, then we will use the 
saliva for the study. The saliva sample, will be used for genetic studies. Saliva 
samples will be used to isolate genomic DNA and carry out genotyping and 
sequencing. 
 
A waiver of HIPAA authorization is not required as the data or specimens will be 
de-identified and are obtained under the statutory authority of the CCR to 
disseminate data for research purposes, and the distribution occurs in the context of 
a state-mandated disease registry's operations. The CCR is not a covered entity nor 
a business associate to any of the facilities and physician offices that report cases of 
cancer under the state mandate. The terms and conditions of data access and release 
are established by CDPH. 
 
We will request the IRB permission to provide participants with incentives for 
survey completion ($20) and saliva sample donation ($30). 
 
 
 
8) 
Data and/or Specimen Management and Confidentiality 
All data will be collected and maintained within the firewalls of UC Davis.  All 
personnel are trained on maintaining confidentiality of patient data through physical 
and electronic processes.  All research staff who will be working on the project 
have current Human Subjects training certificates and have signed confidentiality 
agreements. All CCR policies and procedures for release of data will be followed 
promptly.  
The data will not be released outside the UC Davis firewall. All data will be 
password protected and stored on a controlled access computer. Only research staff 

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associated with the study will have access to the data. All research records will be 
password protected and stored on controlled access computers. Any paper copies 
will be in locked cabinets in locked rooms that are only accessible by study staff. 
No paper will be left unattended. All study materials will not leave our secure 
building and will never be left unattended in unsecured locations. 
 
No personal identifiers will be included in the analytic files. After all surveys are 
completed, data will be electronically stored on a secure computer server. Paper 
copies will be shredded. No identifying information will be kept on the paper 
surveys prior to them being destroyed. Unique study ID numbers will be assigned, 
and the key will be password protected on a secure computer server. 
 
No identifying information will be published. The only identifying information that 
will be used is the participant’s name, address, and phone number to mail the study 
packet and conduct follow-up phone calls, if necessary. Contact information will be 
destroyed after research collection is completed and unique study ID numbers have 
been assigned to all material we will mail toparticipants to ensure confidentiality.  
 
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.  
 
9) 
Data and/or Specimen Banking 
De-identified surveys and genetic data will be stored under firewall in 
UC Davis Cancer Center and UC Davis Genome center on password 
protected servers. De-identified biospecimens and DNA samples will be 
stored in the Carvajal-Carmona laboratory at the genome center. Data, 
biospecimens and DNA will be stored indefinitely. 
10) Provisions to Monitor the Data to Ensure the Safety of Subjects 
NA 
11) Withdrawal of Subjects 
Should subjects withdraw from the original study, we will 
remove/destroy all data, biospecimens and samples belonging to them. 
12) Risks to Subjects 
Risk level is minimal. There is no physical or economic risk. The greatest potential 
risk is loss of confidentiality, but, as described above, this risk will be minimized 
due to the policies and procedures UC Davis follows to protect the confidentiality 
of study participants. Other than for recruitment purposes, all data collected will be 
de-identified.  
 
An additional minimal risk is potential negative emotional responses to questions 
about cancer and life experiences, but we have designed our survey to be of 
minimal psychological risk. Participation in this study is voluntary, and subjects 

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may decline to participate or skip any question they do not wish to answer.  
Participation in the biospecimen collection of saliva is non-invasive safe procedure, 
which may make the subject uncomfortable for a couple of seconds as saliva from 
the mouth is collected into a small test tube.  
 
 
13) Potential Benefits to Subjects 
Cancer survivors may be motivated to participate in an effort to understand 
potential cause(s) of their cancer. Otherwise, there are no direct benefits to 
participation. 
 
14) Multi-Site Research 
NA 
 
15) Community-Based Participatory Research 
NA 
 
16) Sharing of Results with Subjects 
NA, results will not be shared with subjects. 
 
17) Prior Approvals 
The Carvajal-Carmona lab has BUA approval (#R1713) to store and process the 
type of biospecimens collected for the study, to carry out omics experiments and 
cell line/tissue culture work. We will also request approval for the California state 
IRB to obtain patient information from the Cancer Registry. This study will 
therefore require IRB approvals from UC Davis and from the state. 
 
18) Provisions to Protect the Privacy Interests of Subjects 
As described above, all research staff are trained to protect the 
confidentiality of cancer data. 
19) Compensation for Research-Related Injury 
NA 
 
20) Economic Burden to Subjects 
NA 
 
21) Drugs or Devices 
NA 
 

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22) ClinicalTrials.gov Registration 
 
NA 
Section 1:  NIH Funded Studies 
If yes to BOTH, the study must be registered on Clinicaltrials.gov. 
Yes  
X
 
This study is funded by the NIH. (If this study is not funded by NIH, go to 
Section 2.) 
 
One or more human subjects will be prospectively assigned to one or more 
interventions (which may include placebo or other control) to evaluate the effects 
of those interventions on health-related biomedical or behavioral outcomes. 
 
Section 2:  Studies subject to FDA jurisdiction 
If yes to ANY the study must be registered on Clinicaltrials.gov. 
Ye
s 
 
 
This is a prospective clinical study of health outcomes in human subjects that 
compares an intervention with an FDA-regulated device against a control. This 
is not a small clinical trial to determine the feasibility of a device, or a clinical 
trial to test prototype devices where the primary outcome measure relates to 
feasibility and not to health outcomes. 
 
This is a pediatric postmarket surveillance of a device as required under section 
522 of the Federal Food, Drug, and Cosmetic Act. 
 
This is a controlled clinical investigation, other than a phase I clinical 
investigation, of a drug subject to section 505 of the Federal Food, Drug, and 
Cosmetic Act or to section 351 of the Public Health Service Act. 
To view a flowchart describing applicable clinical trials subject to FDA jurisdiction click 
here. 
 
Section 3: Publishing the results 
If yes to BOTH the study must be registered on Clinicaltrials.gov. 
Yes  
 
This study prospectively assigns people or a group of people to an intervention, 
with or without concurrent comparison or control groups, to study the cause-and-
effect relationship between a health-related intervention and a health outcome. 
 
The PI has access to and control over all the data from the clinical trial and has 
the right to publish the results of the trial and plans to publish the results in a 
journal that follows the ICMJE recommendations.  
This requirement includes studies of behavioral interventions. 
 
Section 4: Registration on Clinicaltrials.gov is not required 
Yes  

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x 
I have read sections 1-3 above and registration on clinicaltrials.gov is not 
required for this research.  
 
23) Criteria for 10 Year Approval  
 
NA, this is a five-year study 
 
If yes to all items below this research may qualify for a 10-year approval period. 
 
Yes  
 
This research involves no more than minimal risk. 
 
This research does not receive any federal or state government funding or 
funding from a private funder who requires annual review per contract. 
 
This research is not subject to FDA jurisdiction.  
 
This research does not include prisoners as participants. 
 
This research is not subject to SCRO oversight. 
 
This research is not subject to oversight by the Research Advisory Panel of 
California (RAP of C). 
 
No personnel involved in the design, conduct, or reporting of this research have a 
new unreported related financial interest (RFI) in this study.