Frequently Asked Questions

Enrollment Details

What is the purpose of this study?

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).

Why am I being asked to participate?

You are being asked to participate because: • You are between the ages of 45 and 75; 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.

Do I have to participate in this study?

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.

Will I benefit from participating?

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.

What does this research study involve?

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.

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

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.

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

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.

Will it cost me anything to participate?

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.

What if I have questions?

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

Will my private information be protected?

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

Specimens & Use

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

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.

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

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.

Who will use my samples and see my information?

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.