Dana-Farber has been a leader in the research of precursor hematologic conditions for many years. Our team is committed to early detection and intervention to prevent progression to incurable blood cancers.
Our team was the first to discover CHIP and its link to blood cancers and cardiovascular disease, and has been leading several efforts to understand the genomic, genetic, and epigenetic factors that influence disease progression for other precursor conditions.
We offer several clinical trials of early therapeutic intervention to prevent progression and cure the disease in its early state.
Current Clinical Trials
This study is for patients with high-risk smoldering multiple myeloma. It is a phase 2 non-randomized study, so all patients receive the same treatment. This study uses a combination of 4 drugs: daratumumab (injection), bortezomib (injection), dexamethasone
(oral) and revlimid (oral). Patients must come to Dana-Farber once a week for the first 2 cycles, three times a month for cycles 3-6, and twice a month for cycles 7-24. After the completion of all 24 cycles of treatment (2 years), patients will be
monitored for three years.
This study is for patients with high-risk smoldering multiple myeloma. It is a phase 3 randomized, unblinded study with two arms. One arm will receive revlimid (oral) and dexamethasone (oral), standard of care for high-risk smoldering multiple myeloma
patients. The other arm will receive revlimid (oral) and dexamethasone (oral) in combination with isatuximab (infusion), the investigational drug. Treatment is given every 28 days, for 24 cycles, for a total of 2 years. After treatment completes,
patients will be followed until disease progression or until the study concludes, whichever is first.
This study is a randomized, double blind, placebo-controlled phase 2 study for patients with high-risk monoclonal gammopathy of undetermined significance (MGUS) or low-risk smoldering multiple myeloma. Metformin or a placebo will be taken daily for 6
months. The metformin dose will increase from 500mg to 1500mg over the 6-month period. The study drug is shipped directly to the patients. Patients are required to come to Dana-Farber only at screening and at the end of treatment. After completing
the 6-month treatment, patients will be followed for 4.5 years.
PCROWD Study
Irene Ghobrial, MD, launched the PCROWD research study to collect tissue samples for patients diagnosed with precursor conditions for the purpose of understanding the progression and clonal evolution of blood cancers, with the ultimate aim of developing
targeted therapeutic agents that can eliminate the early clones of disease. The study has helped identify mutations associated with disease progression.
Learn more about the PCROWD study.
PROMISE Study
Dr. Irene Ghobrial is leading this screening study of individuals at high-risk of precursor conditions of multiple myeloma, such as monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma. The goal is to establish a screening method
for high-risk individuals and to study clinical data and tissue samples to understand why some patients progress to myeloma and others do not.
Learn more about the PROMISE study.
IMPACT Study
In consideration of the urgent need for rapidly sharing discoveries that can potentially inform COVID-19 treatment decisions and prevention policies within and beyond our Center for the Prevention of Progression Clinic, Dr. Irene Ghobrial and colleagues
are launching The IMPACT Study. IMPACT is a prospective cohort study to identify the prevalence and pathogenesis of COVID-19 in individuals with precursor conditions to hematologic
malignancies and in healthy populations. It is enrolling individuals nationwide who are enrolled and prospectively followed in large cancer epidemiology and tissue banking studies at Dana-Farber. All participants enrolled in IMPACT are screened for
SARS-CoV-2 seropositivity and will then be followed and undergo additional blood collection and testing over a one year period. The overall goal of IMPACT is to understand the short- and long-term impact of COVID-19 on the immune system of healthy
individuals and individuals with underlying immune dysregulation, who may be at high risk of poor outcome.
Research Highlights
CHIP
Benjamin Ebert, MD, PhD, Chair of Medical Oncology, made the landmark discovery identifying clonal hematopoiesis of indeterminate potential (CHIP), a pre-malignant state occurring in more than 10 percent of people over age 70. People with the condition
have somatic mutations associated with leukemia in cells of the blood or bone marrow, but do not meet the criteria for a hematologic cancer diagnosis. Such individuals are at significantly elevated risk (10-fold increase) of hematologic malignancy,
therapy-related leukemia, overall mortality, and cardiovascular disease.
Age-related clonal hematopoiesis linked to adverse outcomes, New England Journal of Medicine, 2014 November 26
Clonal hematopoiesis of indeterminate potential and its distinction from myelodysplastic syndromes, Blood, 2015
Smoldering Multiple Myeloma
Nikhil Munshi, MD, and his colleagues have identified the genomic changes that occur as smoldering multiple myeloma (SMM) advances to myeloma.
Their findings lay the groundwork for tests that can identify patients whose SMM is likely to progress rapidly to myeloma, and who could benefit from prompt treatment.