Back

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.

 

View Full Team

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

 

Scroll to Learn More

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 pre-cancerous states (SMM) – approximately 70% of high-risk SMM patients progress to multiple myeloma within five years of diagnosis. SMM is a disease that is 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 routine checkups and is then confirmed through blood tests and a bone marrow biopsy.

What is nivolumab?

A type of immunotherapy that stops the tumor from repressing the immune system response.  It is an antibody that binds to the body’s T cells in order to keep them turned “on” even while the tumor is trying to turn them “off.”  These activated T cells (white blood cells that help your body fight disease) can then attack the cancer 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, nivolumab, and the standard care for myeloma using a type of chemotherapy and steroid. By activating both the immune system and tumor response it is expected 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 samples, will help these researchers identify potential solutions to understanding what causes SMM to develop into multiple myeloma, ways to prevent the progression of SMM, and 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 prolonged survival from 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) with cutting-edge immunotherapy.

Key Insights for Participants

Eligibility

Patients with confirmed diagnosis of high-risk smoldering multiple myeloma (see key criteria below). 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 (see key criteria below)

Requirements

This trial requires both blood and bone marrow samples.

Bone marrow clonal plasma cells ≥10% and ≤60% and any one or more of the following 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, bone lesions), which are the four clinical characteristics which indicate a patient has multiple myeloma.

More +Less -

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

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.

More +Less -

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

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

More +Less -

You may NOT participate in this study if you have a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease.

You may NOT participate in this study if you have a history of symptomatic disease such as; rheumatoid arthritis, systematic progressive sclerosis, systemic lupus erythematosus,

autoimmune pneumonitis, autoimmune vasculitis, and motor neuropathy considered of autoimmune origin.

More +Less -

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 cancer 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 are required when you enroll in a clinical trial.

Boston - Massachusetts

Dana-Farber Cancer Institute
Irene Ghobrial, MD
617-632-4198
Contact

Boston - Massachusetts

Beth Israel Deaconess Medical Center
Jacalyn Rosenblatt, MD
Contact

Resources

Support for this study comes from the Bristol-Meyers Squibb Company.
Learn more about BMS +Learn more about nivolumab +
Here are some links to organizations that provide more information about multiple myeloma, and may provide information on patient support, treatment options, and current clinical trials.
Multiple Myeloma Research 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.

(Please fill out all fields and questions below to better assist you.)