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FAQs
Frequently Asked Questions
Drawing blood may cause some discomfort. In addition, it is also possible that the analyses and/or results, including the identification of genetic abnormalities in you, could be seen by unauthorized individuals.
We have procedures and security measures in place to ensure that it will be extremely difficult for this to happen.
Learning that you may have the COVID-19 antibody may cause anxiety, fear, or general stress. This worry may be countered by knowing you have an opportunity to learn that you may have been infected with COVID-19 at some time in the past and never knew it. It may mean that you have some immunity to the COVID-19 virus. However, more research is needed to help us better understand the role COVID-19 antibodies play in a person who has been exposed to the virus.
While it is possible that public knowledge of your genetic factors or the diagnosis COVID-19 could lead to problems with insurance or employment, the confidentiality of participant identities will be strictly preserved under this study, minimizing such risks in this context. Genomic information will not be included in your medical record.
Multiple myeloma is a blood cancer found in the bone marrow.
In a healthy person, plasma cells help to fight infections. But in a person with multiple myeloma, abnormal plasma cells (myeloma cells) build up in the bone marrow and can lead to more obvious problems like bone lesions, anemia, and problems with kidney function.
By studying blood and bone marrow samples of people at risk for developing multiple myeloma, we aim to identify ways to prevent multiple myeloma.
Once you are enrolled as a participant in The PROMISE Study, you will receive a kit in the mail with three vials and instructions for making your appointment for the free screening. Most screenings will be completed at a Quest Diagnostics lab, which offers nationwide availability throughout its 2200+ locations.(https://appointment.questdiagnostics.com/patient/confirmation)
Once you complete your scheduled appointment for the free screening, you should hear from someone on our research team to learn more about your results. People who test positive for a precursor condition will be invited to continue on in our study. People who do not have a precursor condition will be encouraged to follow up with their healthcare provider about their risks and what, if any, further screenings may be advised by the practitioner.
No matter what the results, every person who participates is helping us to further our knowledge of multiple myeloma and the associated precursor conditions.
Examples of the studies that may be done include, but are not limited to, studies that will help us:
• To identify how often (or common) the COVID-19 virus occurs in people at increased risk for blood cancer.
• To understand how COVID-19 may affect risks for blood cancers like multiple myeloma.
• To define changes that occur in blood of people who are at increased risk for blood cancer and have been infected with COVID-19.
Some of these studies may be published.
Feel free to reach out to our staff. We are exploring possibilities to help enable all potential participants to engage with The Promise Study and for all eligible participants to receive a free screening. Find out where the closest Quest Diagnostics lab is located.(https://appointment.questdiagnostics.com/patient/confirmation)
Your specimens and health information will be available to researchers at the Dana-Farber/Harvard Cancer Center who have approval from the DFCI Institutional Review Board to use your samples and health information for research that is conducted under this research study.
No information that could identify you will be sent with your specimens. In addition, if you agree, we will share your results with central data repositories (such as the National Institutes of Health and others), which may share information without your permission. Your name or other directly identifiable information would not be provided to these central repositories.
The earliest warning signs for multiple myeloma are what we call "precursor conditions." When a person has a precursor condition, it means that the body is prouducing abnormal cells that may one day develop into cancers such as lymphoma, leukemia, Waldenström macroglobulinemia, and multiple myeloma.
Most people with precursor conditions do not experience symptoms, and since doctors rarely screen for them, they are often only discovered after routine blood tests.
Most people who are diagnosed with one of these warning signs will never develop blood cancer. However, most everyone who does develop blood cancer had one of these warning signs or precursor conditions first.
The PROMISE study seeks to determine what causes these early warning signs to develop into multiple myeloma so that we can find an effective way to prevent it from happening.
In addition to the PROMISE Study, we offer an alternative study called PCROWD for people who have already been diagnosed with a precursor condition. We encourage you to visit the PCROWD site and enroll if you may be eligible.
MGUS is a pre-cancer condition in which abnormal proteins are found in the blood. These abnormal proteins are made by infection-fighting white blood cells in the bone marrow. By itself, this protein usually causes no health problems, and most people are unaware they have MGUS until it is diagnosed in a routine blood test.
Is MGUS dangerous? Some people with MGUS never develop any problems from it, but for others it progresses to multiple myeloma.
Is MGUS common? About 3% of all people aged 50 and above have MGUS that is detectable through a blood test. Those percentages are generally 2-3 times higher for African Americans and for people who have a close family member who has multiple myeloma.
The IMPACT study is an affiliate study of the PROMISE or PCROWD Studies and will analyze blood samples for up to one year to study the relationship between COVID-19 exposure and the immune system.
All participants enrolled in IMPACT will receive a free antibody test to determine if they have been exposed to the virus causing COVID-19.
Your Data: The PROMISE Study is committed to your data security. Our partners are leaders in research and data sciences. Every item of data and physical access point is secured for our participants' privacy and protection. From the blood draws at Quest Diagnostics labs to data warehousing at The Broad Institute, your information will be sent to us, and maintained by us, with the highest standards of security and confidentiality.
Our Study Reports: Our research is looking for trends among groups of people with similar characteristics and biomarkers. Your name and identifying information will always be kept private. We will never share study reports that provide personal details about any specific individual.
We do not share your data for any reason with anyone outside this study. You will not receive marketing materials of any kind.
Smoldering multiple myeloma (SMM) is a warning sign for multiple myeloma. People who have this condition have abnormal proteins in the blood and abnormal cells in the bone marrow. Smoldering multiple myeloma typically develops after monoclonal gammopathy of undetermined significance (MGUS).
Is smoldering multiple myeloma dangerous? Some people with smoldering multiple myeloma never develop any problems from it, but for others, SMM progresses to multiple myeloma. One study found that 75 percent of patients with smoldering multiple myeloma develop myeloma within 15 years of diagnosis.
Sometimes called Waldenström's, Waldenström's Syndrome, or WM
Waldenström's macroglobulinemia is a rare white blood cell cancer. It is a slow-growing type that forms mostly in the bone marrow. It can slow down your body's ability to make healthy blood cells, which may lead to anemia and a weakened ability fight infections.
Is Waldenström's dangerous? At this time, WM is not curable, but people can live for decades after diagnosis. There are also effective treatments that can slow the progress or cause remission. Many people live with it for years before developing noticeable problems. Patients often report no symptoms when they are diagnosed, frequently during a routine blood test.
Over time, symptoms that may develop include an enlarged liver, spleen, or lymph nodes, headaches, fatigue, weight loss, bruising, and nerve damage.
Nearly every person who develops this incurable cancer called Waldenström's macroglobulinemia had MGUS or SWM before developing cancer. (SWM stands for Smoldering Waldenström's macroglobulinemia)
SWM and MGUS are pre-cancerous conditions. Although "watchful waiting" is appropriate for many people, this study aims to identify the most effective ways to prevent, treat and cure these cancers that can turn fatal.
You are being asked to participate because you have risk factors for blood cancer and its precursor conditions. We are inviting individuals currently enrolled in the PROMISE and PCROWD research studies to participate. We are specifically studying people who have been identified at an increased risk for blood cancer so we can learn how COVID-19 affects them. That means either:
1. You qualify to enroll in the PROMISE STUDY if --
• You are between the ages of 45 and 75; and
• You are of Black or African American;
and/or
• You have a first-degree relative, such as a parent, a sibling, or a child, who has been diagnosed with multiple myeloma or one of the following related plasma cell conditions: MGUS , SMM. or Waldenstrom’s macroglobulinemia.
2. You qualify to enroll in the PCROWD STUDY because --You are 18+ years and have a diagnosis of one of the following:
• Clonal Hematopoiesis of Indeterminate Potential (CHIP)
• Monoclonal B cell Lymphocytosis (MBL)-such as Polycythemia Vera, Essential Thrombocythemia, or Myelofibrosis
• Myelodysplastic Syndrome (MDS)
• Monoclonal Gammopathy of Undetermined Significance (MGUS)
• Myeloproliferative Neoplasms (MPN)
• Smoldering or Indolent Multiple Myeloma (SMM)
• Smoldering Waldenström Macroglobulinemia (SWM)
• OTHER precursor hematological condition
African Americans typically have 2-3 times greater likelihood of developing multiple myeloma (javascript:void(0))and its precursor conditions.(javascript:void(0))
We want involvement from people groups who are most affected so that we can learn more about the causes that drive those increased risks. Our ultimate goal is to develop a screening plan so that multiple myeloma can become a treatable and curable cancer.
The odds are different, depending on the type of precursor condition and the amount of affected cells. Testing positive for a precursor condition is not automatically cause for alarm, and people who test positive are advised to follow up with their local heatlhcare provider to better assess their individual risks and options. We do know that that MGUS (javascript:void(0))has a lower rate of progression than SMM.(javascript:void(0))
For a broad perspective, a recent study estimates the risk of progression for MGUS was 10% at 10 years, 18% at 20 years, 28% at 30 years, 36% at 35 years, and 36% at 40 years, but these odds are not the same for every individual.
However, at this time, many people are not screened adequately for MGUS and SMM, so The PROMISE Study aims to add significant data to this growing body of research.
SOURCE: https://www.ncbi.nlm.nih.gov/pubmed/29342381
The PROMISE Study is only enrolling adults, age 45-75, with the following qualifications:
a. African Americans
b. Close family relatives of someone with multiple myeloma or one of its precursor conditions including -
– Monoclonal Gammopathy of Undetermined Significance (MGUS)
– Smoldering Multiple Myeloma
– Waldenström Macroglobulinemia
If you have already been diagnosed with a precursor condition, we have an alternative study that may be right for you, called The PCROWD study.(https://pcrowd.dana-farber.org/) Please visit that site to learn more. Thank you for your interest.
By participating in this study, you may learn that you have COVID-19 antibodies.
This may be helpful information for you as an individual to make informed decisions about your risks.
It is also helpful for researchers to know as we continue to learn more about the virus and how it affects certain groups of people. We will research your immune system as being at risk for blood cancer and how that impacts your response to COVID-19 and potential vaccinations.
Your participation in this study could help the medical community learn more about who is most at risk and why. This knowledge could help doctors provide better COVID-19 treatment and/or vaccine options to future patients. It could also help future patients make better decisions about their overall health risks.
Although taking part in this research study may not directly benefit you, the information gained from your participation could potentially help other people who test positive for COVID-19.
If you believe one of your first-degree family members has had some form of blood cancer, you may be able to help. A first degree family member is a parent, a sibling or a child.
If you're unsure of the type, but you have the ability to ask your family member, please do so and refer your family member to this list on our home page.(undefined) If your family member was diagnosed with one of those conditions, or if you are African American, please join our study. (https://redcap.partners.org/redcap/surveys/?s=FF3LA48FLY)
If you are still unsure, you may speak with a staff member by calling 617-582-7002.(tel:617-582-7002)
The PROMISE Study does not provide ongoing medical care after the screening, and for people who test positive for a precursor condition, follow up care is highly recommended. The PROMISE Study assumes no medical or legal responsibility for any treatment decisions made during follow-up care with your local provider.
We will provide all materials needed if participants who test positive during the screening process allow our team of researchers to track updates and changes related to the precursor condition. If you choose to allow us to track your updates, we will provide additional forms for your consideration that will allow your provider to share medical information with our research team. The PROMISE Study will not order any further tests, but we will appreciate all participants who share information with us and allow us to learn from any tests ordered by your local healthcare provider.
All U.S. citizens, and thus all potential participants, are encouraged to maintain adequate health insurance for any necessary treatments. If you do not have health insurance, please visit the U.S. Healthcare Marketplace (https://www.usa.gov/health-insurance)or explore other options for coverage to meet all your healthcare needs.
We are grateful for the support of all healthcare providers and have developed some simple ways for your patients to participate in our study without adding an additional burden for you or your staff members.
We have contracted with Quest Diagnostics labs to send additional vials to us when your office orders labwork for your participating patients. We may request copies of labs, and would like to be informed of changes in the status of precursor conditions.
Management of permissions and forms will be handled through our participant portal and the patient will bear the primary responsibilitiy for initiating any sharing of information. We recognize that our healthcare providers will play a critical role in this research by referring patients and by allowing seamless information sharing whenever possible.
We are grateful for your assistance, your referrals, and your shared commitment to finding better options for treating precursor conditions and advancing an eventual cure for multiple myeloma.
In addition to keeping the process simple, and coordinating with labs and patients to minimize requests, we will be sharing updates and progress with interested providers. As our research data grows, we hope to develop risk models and tools to share with healthcare providers to broaden support for evidence-based treatment decisions.
Yes, you may refer any eligible participant to us, and you may also encourage any patient who has multiple myeloma, SMM, WM, or MGUS to invite their first-degree relatives, age 45-75, to receive a free screening for precursor conditions by signing up through our study.
We are also offering free screenings to any African American adult, age 45-75.
Thanking you in advance! Please share: enroll.promisestudy.org
After you sign your consent and join the study, test kits will be mailed to your home.
You will take the kit to a Quest Diagnostic lab where a small blood sample will be taken.
In gathering your samples, at first, we are asking your permission to:
A) Obtain a small sample of blood (2-4 tablespoons).
B) Check your blood for COVID-19 antibodies.
C) Participants will receive the COVID-19 antibody test results from Quest Diagnostics by email.
We will send you a research kit to submit peripheral blood (2-4 tablespoons) to the research team at DFCI at 3 months, 6 months, and 1-year post-screening. Take the kit to one of the 2,200 Quest Diagnostics labs in the U.S.
Most people we test will learn that their blood sample has no signs of precursor conditions to multiple myeloma.
A smaller group of people in the study will test positive for a precursor condition to multiple myeloma. Some people who have these precursor conditions will not develop multiple myeloma in their lifetime, but others will. We want to understand why these groups are different and discover new ways to prevent progression to multiple myeloma.
If you turn out to be in the group that tests positive, we will speak with you privately about what your results may mean and how you may wish to proceed. We could also speak with your doctor if you want us to. We will invite all people who test positive to participate in the ongoing study activities.
If your sample reveals evidence of a precursor conditions, we will invite your ongoing participation in the PROMISE study.
The PROMISE Study researchers would like to track the progress of people who test positive for a precursor condition. Although all people who test positive for precursor conditions should seek follow up care from a trusted hematologist or an oncologist in their area, it may be important to know that many people who have precursor conditions never progress to cancer or develop any noticeable symptoms. By identifying people with precursor conditions earlier and by tracking changes over time, we will learn more about effective treatments that eventually lead us to a cure.
Every person's data helps. Whether you test positive or negative, and even if those precursor conditions remain otherwise unnoticeable throughout your life, your sample will help us better understand the differences between people who remain symptom-free and those who develop symptoms.
We welcome all study-eligible individuals to join us (https://redcap.partners.org/redcap/surveys/?s=FF3LA48FLY)in building a healthier future for everyone.
You have the right to choose not to enroll in this study. If you decide not to sign enrollment forms, you cannot participate in this research study.
You can stop being in the research study at any time. Tell the research doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop. Any samples of yours that were anonymized (identifying information removed) will not be discarded. Leaving the research study will not affect your medical care outside of the research study.
We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data.
Federal law requires that DFCI protect the privacy of the information that identifies you. If you agree to participate in this study, you are authorizing the researchers at participating institutions to access and use your private information. Because the research will be ongoing, your authorization will not expire unless you withdraw it in writing by contacting the Office of Human Research Studies, 450 Brookline Avenue, Boston, MA 02215.
The results of this research study may be published. You will not be identified in publications without your permission.
There are currently two important types of testing related to the COVID-19 virus in the United States.
1. Diagnostic tests (Answering the question, "Do I have the virus?")
2. Antibody tests (Measuring, "Is my body already making disease-fighting antibodies?")
Diagnostic tests detect an active infection with COVID-19.
• These infection tests can be done through a nasal swab or a saliva sample.
• They look for active infections by detecting a molecular polymerase chain reaction (PCR) or by detecting antigens – strands of proteins that make up the virus.
Antibody tests are done through a blood test to detect a previous infection with or exposure to COVID-19. This study provides antibody tests only.
Learn more about COVID-19 testing on https://www.fda.gov/consumers/consumer-updates/coronavirus-disease-2019-testing-basics
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