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Immunotherapy to Prevent Progression in Multiple Myeloma

Dr. Irene Ghobrial, MD

Senior PhysicianDana-Farber Cancer InstituteView Bio

Dr. Ghobrial received her MD in 1995 from Cairo University School of Medicine, Egypt. She completed her Internal Medicine training at Wayne State University, Mich., and her Hematology/Oncology subspecialty training at Mayo Clinic College of Medicine, Minn.

She joined Dana-Farber in the field of Waldenstrom’s macroglobulinemia and multiple myeloma in 2005. She is conducting research in the area of homing and migration of B cells and novel therapeutic agents in Waldenstrom’s macroglbulinemia and multiple myeloma.

 

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Meet the Team

  • Irene M. Ghobrial, MD, Dana-Farber Cancer Institute
  • Viktor A. Adalsteinsson, PhD, Broad Institute
  • Gad Getz, PhD, Broad Institute
  • Salomon Manier, MD, Dana-Farber Cancer Institute
  • Jihye Park, PhD, Dana-Farber Cancer Institute
  • Yujia Shen, PhD, Dana-Farber Cancer Institute
  • Eliezer Van Allen, MD, Dana-Farber Cancer Institute

 

  • Patient Advocate: Jenny Ahlstrom

 

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About This Catalyst Clinical Trial

Are you or a loved one currently facing a pre-cancerous state of multiple myeloma, known as smoldering multiple myeloma (SMM)? Stand Up To Cancer (SU2C) is supporting a phase II clinical trial that may help delay or prevent the progression of SMM to multiple myeloma, and create new therapies to better treat these tumors and improve outcomes for patients.

Multiple myeloma, a cancer of the bone marrow, almost always progresses from a pre-cancerous state (SMM); approximately 70% of high-risk SMM patients progress to multiple myeloma within five years of diagnosis. SMM is a sometimes called asymptomatic myeloma. It involves a higher level of plasma cells in the bone marrow and a higher level of certain proteins, but patients do not usually experience any symptoms. SMM is usually detected during a routine checkup and is then confirmed through blood tests and a bone marrow biopsy.

What is elotuzumab?

Elotuzumab is a type of immunotherapy called a monoclonal antibody that targets a receptor which is crucial to stimulating immune cell activity. This receptor is also found on myeloma (MM) cells. By activating this receptor, immune cells like Natural Killer (NK) cells, are turned “on.” Using the same cell pathway, the myeloma cells are flagged for destruction by the body’s immune cells.

SMM is not typically “treated” except in clinical trial settings. Researchers on the Multiple Myeloma Clinical Trial team will treat patients in the early stages of high-risk SMM with immunotherapy, elotuzumab, and the standard care for myeloma using a type of chemotherapy and steroid. By activating both the immune system and tumor response, researchers expect that this type of early intervention will delay or prevent the pre-cancerous disease progression to multiple myeloma.

Patient samples collected throughout this trial, via blood and bone marrow sampling, will help these researchers identify potential solutions to understanding what causes SMM to develop into multiple myeloma, identify potential ways to prevent the progression of SMM, and develop new therapies to both intercept and delay multiple myeloma and organ damage associated with the disease.

This promising research may lead to a new standard of care for SMM patients, utilizing blood biopsies and early intervention to improve patients’ response to treatment and to prolong survival for those with this disease.

We Need You

Why Your Participation Matters

This trial could change the standard treatment for patients through early intervention that has the potential to delay organ damage associated with multiple myeloma, improve patient response to treatment and increase the survival rate of patients with this disease. Your involvement is needed to learn if we can help improve outcomes for cancer patients using a combination of standard myeloma treatment (chemotherapy and steroids) and with cutting-edge immunotherapy.

Key Insights for Participants

Eligibility

Patients with confirmed diagnosis of high-risk smoldering multiple myeloma are eligible to enroll. There are additional criteria that must be met to participate, or that may prevent a patient from participating.

Key criteria are summarized below and can be found in detail on ClinicalTrials.gov. Interested patients will need to review their medical histories with clinical trial patient coordinators before they can be accepted to participate in this trial.

Gender:
Female or male
Age Range:
18 years and older
Diagnosis:
High-risk smoldering multiple myeloma

Requirements

This trial requires both blood and bone marrow samples.

It requires bone marrow clonal plasma cells greater than 10% and less than 60% and any one or more of the criteria listed at ClinicalTrials.gov.

You are NOT eligible to participate in this study if you have any known evidence of active multiple myeloma or evidence of CRAB criteria (elevated calcium levels, renal

insufficiency, anemia or bone lesions), the four clinical characteristics indicating a patient has multiple myeloma.

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Before enrolling in this study, patients must have at least two years between a diagnosis or treatment for another malignancy and the start of the study. The exceptions are

complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

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If you are physically able to become pregnant, you must have a negative pregnancy test and can no longer be breastfeeding before beginning this study due to potentially harmful

effects to a child or unborn child from portions of this study’s treatment.

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You may NOT participate in this study if you have already received other therapy for overt multiple myeloma.

You may NOT participate in this study if you have ongoing, uncontrolled other illnesses such as congestive heart failure, active infection, or unstable angina pectoris.

Participate

You play a vital role.

Here are the locations where you can currently participate in this clinical trial. If you or a loved one is interested in enrolling and learning more about this study, please contact the patient coordinator at your preferred site. The patient coordinator is there to help you understand every aspect of the clinical trial process and answer any questions you may have.

Once you contact the patient coordinator, he or she will start by reviewing your medical history with you to see whether you meet all the criteria to participate. The coordinator will then guide you through a review of the study and detailed “informed consent” documents that you are required to sign when you enroll in a clinical trial.

Boston - Massachusetts

Dana-Farber Cancer Institute
Alexandra Savell
Research Project Manager II
P: 617-632-3539
Contact

Resources

Support for this study comes from the Bristol-Meyers Squibb Company.
Learn more about BMS +
Here are some links to organizations that provide more information about multiple myeloma, and may also discuss patient support, treatment options, and current clinical trials.
Multiple Myeloma Research Foundation +International Myeloma Foundation +The Leukemia & Lymphoma Society +
For additional resources, please visit the following support services:
The American Cancer Society +Cancer.Net +CancerCare +Patient Advocate Foundation +

Find out if there's a trial for you. Reach out today.

Even if you do not meet the requirements for this trial, there may be other trials for you. Get started with the SU2C Clinical Trial Finder, a free and confidential cancer clinical trial matching and referral service.

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