Question 1

What is the purpose of this study?

Accepted Answer

The purpose of the PROMISE research study is to analyze some of your blood for precursor conditions to multiple myeloma such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM).

Question 2

Why am I being asked to participate?

Accepted Answer

You are being asked to participate because: 
• You are 30 years old or older; and 
• You are of African American descent; 
 
and/or 
• You have a first-degree relative, such as a parent, a sibling, or a child, who has been diagnosed with multiple myeloma, another blood cancer, or one of the following related plasma cell conditions: MGUS , SMM. or Waldenstrom’s macroglobulinemia.

Question 3

Do I have to participate in this study?

Accepted Answer

No. Taking part in this study is voluntary. Even if you decide to participate, you can change your mind and leave the study at any time. However, if you do agree to participate, some of your testing results, along with the blood samples you provide, will remain in our data and sample repositories.

Question 4

Will I benefit from participating?

Accepted Answer

Although taking part in this research study may not directly benefit you, the information gained from your participation is likely to generate important information which will help future patients with blood cancers, and individuals at high risk of developing a blood cancer.

Question 5

What does this research study involve?

Accepted Answer

We are asking your permission to obtain samples of blood (2-4 tablespoons) from 3 tubes. Analysis will be performed on your blood to test for multiple myeloma precursor conditions.

Question 6

What will I have to do if I agree to participate in this study?

Accepted Answer

Upon Enrollment:
You will be asked to provide data about you and to answer a survey that includes questions about your health, family, and work.
You will also be asked to go to a local clinic or lab to give a blood sample to ship back to us for analysis.
This sample will be used to determine whether you are positive or negative for multiple myeloma precursor conditions. 
The PROMISE research study will last for at least three years.
 
If you test positive for a precursor condition:
You will be invited to take part in a group of participants that will be followed on a regular basis.
You will also be counseled on the appropriate next steps including starting clinical follow up with a local health care provider to determine your risk of developing active multiple myeloma.
You may be found to have multiple myeloma during this workup. 
 If you test negative for multiple myeloma precursor conditions: 
We will ask you follow up questions from time to time and you will be screened again in 3 years. 
We ask your permission to contact you or your doctor to obtain information about your disease history.

Question 7

Can I stop being on the research study and what are my rights?

Accepted Answer

You have the right to choose not to sign this form. If you decide not to sign this form, 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.

Question 8

Will it cost me anything to participate?

Accepted Answer

There will be no additional costs to you for participating in this study. 
 
However, we will do various medical tests as part of this study. We will give you the results. When you receive potential follow-up care if screened positive, your doctor will bill you or your insurance company per usual practice. If you do not have insurance, or if your insurance will not pay, you will be responsible for the cost of follow-up care.

Question 9

What if I have questions?

Accepted Answer

If you have any questions, call 617-582-8544 or email promise@partners.org

Question 10

Will my private information be protected?

Accepted Answer

We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of study data.

Question 11

How will the PROMISE study protect data privacy?

Accepted Answer

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.

Question 12

Can I speak with someone if I need help enrolling?

Accepted Answer

Yes, if you have additional questions about enrolling or need assistance with the enrollment process, you may reach out to our staff directly. 
 
We can be reached by email at: promisestudy@partners.org
 
and by phone at: 617-582-7001.

Question 13

Why does the PROMISE study specifically want African Americans to join?

Accepted Answer

African Americans typically have 2-3 times greater likelihood of developing multiple myeloma and its precursor conditions. 
 
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.

Question 14

What if I'm not sure what kind of blood cancer diagnosis is in my family history?

Accepted Answer

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. If your family member was diagnosed with one of those conditions, or if you are African American, please join our study. 
 
If you are still unsure, you may speak with a staff member by calling 617-582-8544.

Question 15

How many people are likely to test positive and how will this help science?

Accepted Answer

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.

Question 16

What will happen if my sample tests positive?

Accepted Answer

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.

Question 17

What is the initial sample collection kit?

Accepted Answer

As a registered participant in the PROMISE Study, after scheduling your blood draw appointment, please contact the study team to request a blood draw kit. A team member will promptly mail you the initial collection kit. To get a detailed look at the kit's contents, please watch the video provided below.

Question 18

Do I need to wait until I get a kit from the PROMISE study before I go to a Quest Diagnostics lab?

Accepted Answer

Yes, you will need the kit and the instructions before scheduling your screening with a Quest Diagnostics lab.

Question 19

What are the steps people take to send in a blood sample for the free screening?

Accepted Answer

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.
 
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.

Question 20

What if I don't live near a Quest Diagnostics lab?

Accepted Answer

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.

Question 21

Will you send someone to my home to help me collect my blood sample?

Accepted Answer

Absolutely! If you can't find a Quest Diagnostics lab nearby, simply contact the study team at promisestudy@partners.org. We'll submit an order for a mobile phlebotomist to contact you and schedule a time for a home visit blood draw. On top of reaching out to us, please ensure that you have requested a blood draw kit beforehand, and provide your phone number for appointment scheduling.

Question 22

Are there risks to me if I participate in this study?

Accepted Answer

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.

Question 23

What types of research projects will researchers do with my specimens and health information?

Accepted Answer

Examples of the studies that may be done include, but are not limited to studies that will: 
• Help us understand how cancer forms within the body; 
• Examine whether certain genes or DNA alterations protect or predispose people to developing cancer; 
• Help with the development of new cancer drugs. 
 
Some of these studies may be published.

Question 24

Who will use my samples and see my information?

Accepted Answer

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 Cancer Research Study.
 
Your specimens may be shared with other places, such as the institutions that may conduct the screening analysis and sequencing. 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.

Question 25

What is Multiple Myeloma?

Accepted Answer

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.

Question 26

Who is at higher risk for Multiple Myeloma?

Accepted Answer

These people may be at higher risk for developing Multiple Myeloma:
 
People with a parent, sibling, or child with multiple myeloma or one of its early warning signs - called precursor conditions
African Americans
People with multiple myeloma precursor conditions

Question 27

What are the warning signs for Multiple Myeloma?

Accepted Answer

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.

Question 28

What is MGUS? (Also known as Monoclonal Gammopathy of Undetermined Significance)

Accepted Answer

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.

Question 29

What is SMM? (Also known as Smoldering Multiple Myeloma)

Accepted Answer

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.

Question 30

What is Waldenström's Macroglobulinemia?

Accepted Answer

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.

Question 31

If I test positive during this study, what are the odds I will develop multiple myeloma?"

Accepted Answer

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 has a lower rate of progression than SMM.  
 
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

Question 32

If I have another type of blood cancer pre-condition, can I join the study?"

Accepted Answer

The PROMISE Study is only enrolling adults over the age of 30, 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.  Please visit that site to learn more.  Thank you for your interest.

Question 33

Will this study be involved in my ongoing medical care?

Accepted Answer

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 or explore other options for coverage to meet all your healthcare needs.

Question 34

Will I need to see a certain doctor for follow up care?

Accepted Answer

No, people who test positive for a precursor condition will be encouraged to seek follow up care with a local hematologist or oncologist.  If you need help selecting one, we may be able to offer a referral to local provider.

Question 35

What is involved for Healthcare Providers when patients join this study?

Accepted Answer

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.

Question 36

What resources do you have to help healthcare providers participate?

Accepted Answer

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.

Question 37

Do you want healthcare providers to refer patients to this study?

Accepted Answer

We are no longer accepting new participants onto the PROMISE Study.

If a patient under your care is currently enrolled in the PROMISE Study, they will remain on study and will be followed up per study protocol based on their research-level results.

FAQs

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Frequently Asked Questions