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Multiple Myeloma Clinical Trials and Research

  • The Lipper Center and LeBow Institute for Myeloma Therapeutics encompasses a large, international team of laboratory-based and clinical investigators who are striving to find more effective therapies for multiple myeloma and, someday, a cure. At any given time, dozens of studies and clinical trials for multiple myeloma are underway.

    Our program is a founding institution of the Multiple Myeloma Research Consortium (MMRC), which brings together distinguished researchers and world-renowned academic institutions to speed translation of research to clinical care for myeloma patients.

    The center's research in the laboratory and the clinic is focused on several areas. These include investigations of the genetic abnormalities of myeloma cells; studies of the complex signaling that enables myeloma cells to grow and resist both conventional chemotherapy and novel therapy; efforts to unleash the power of the immune system against myeloma, including CAR T-cell therapy; and explorations of the way in which myeloma cells interact with their environment in the bone marrow and outside the marrow compartment. The mission of this research is to identify and validate novel targets in myeloma, so that new therapies aimed at these targets can be developed, leading to improved outcomes and a cure.

    The center offers patients access to a wide range of clinical research trials. These include studies aimed at improving the outcomes of patients undergoing high-dose chemotherapy and stem cell transplantation; trials using agents like thalidomide and its immunomodulatory derivatives, proteasome inhibitors, which attempt to kill myeloma cells directly and also make it impossible for them to grow in the marrow "neighborhood;" CAR T-cell therapy, an approach that stimulates the immune system vs myeloma; and early intervention trials to prevent disease progression for patients with MGUS or smoldering multiple myeloma. The center also has clinical research trials evaluating supportive therapies, such as bisphosphonates.

    Featured Trials

    19-291: A phase 1/2 study of twice weekly ixazomib plus pomalidomide and dexamethasone in relapsed or refractory multiple myeloma
    This study will evaluate the combination of twice weekly ixazomib with pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. Once weekly ixazomib dosing is currently approved in combination with lenalidomide based on promising efficacy and safety. This trial will utilize a twice weekly dosing schedule of ixazomib in combination with pomalidomide and dexamethasone, aimed to further deepen responses, and is particularly attractive due to being an all-oral and convenient regimen in the current COVID-19 pandemic.
    Principal Investigator: Omar Nadeem, MD

    19-719: Myeloma-Developing Regimens Using Genomics (MyDRUG): Genomics guided multi-arm trial of targeted agents alone or in combination with a backbone regimen
    Personalizing therapy based on specific genetic abnormalities offers an attractive approach to cancer treatment. The goal of this study is to explore targeted agents – either singly or in combination with a backbone regimen – based on specific genomic alterations in a patient’s myeloma.
    Principal Investigator: Giada Bianchi, MD

    19-785: A phase I, open label, study of B-cell Maturation Antigen (BCMA)-directed CAR-T cells in adult patients with relapsed and/or refractory multiple myeloma
    BCMA is a promising target for CAR T-cell therapy as it is expressed at high levels on malignant plasma cells. This study explores PHE885 as a novel CAR-T cell therapy targeting BCMA in patients with relapsed/refractory multiple myeloma. The goal is to use a novel CAR-T manufacturing approach to accelerate the development of anti-BCMA CAR-T cell therapies.
    Principal Investigator: Adam Sperling, MD, PhD

    19-389: A phase 1/2 multicenter, open-label study to determine the recommended dose and regimen, and evaluate the safety and preliminary efficacy of CC-92480 in combination with standard treatments in patients with relapsed or refractory multiple myeloma and newly-diagnosed multiple myeloma
    Cereblon-modifying (CM) agents such as thalidomide, lenalidomide, and pomalidomide play an important role in multiple myeloma treatment. This study explores CC-92480, the most potent of a new generation of oral CM agents, given in combination with dexamethasone, together with other backbone agents all of which have been shown to enhance the anti-myeloma activity of CC-92480 preclinically. Importantly, studies of CC-92480 with dexamethasone alone here at DF/BWCC are ongoing and continue to show remarkable activity and favorable tolerability.
    Principal Investigator: Paul Richardson, MD

    19-054: A phase 1b/2a multicenter, open-label, dose-escalation study to determine the maximum tolerated dose, assess the safety, tolerability, pharmacokinetics and efficacy of CC-220 monotherapy and in combination with other treatments in patients with relapsed and refractory multiple myeloma
    CC-220 is an orally available next-generation immunomodulatory compound that has a similar mechanism of action with lenalidomide and pomalidomide which are established therapies in multiple myeloma treatment. Like CC-92480, as an oral cereblon-modifying agent, CC-220 has increased potency and unique properties that are expected to show improved effectiveness and tolerability in patients. It will be evaluated as a standalone therapy; in combination with dexamethasone; in combination with dexamethasone and daratumumab; in combination with dexamethasone and bortezomib, and in combination with dexamethasone and carfilzomib. Preliminary data for CC- 220 - now known as iberdomide - combined with dexamethasone has shown encouraging activity and minimal toxicity to date.
    Principal Investigator: Paul Richardson, MD

    20-014: Expanded Access Program for belantamab mafodotin in patients with relapsed/refractory multiple myeloma who are refractory to a proteasome inhibitor, and an immunomodulatory agent, and an anti-CD38 antibody
    This study evaluates belantamab mafodotin, a novel, humanized (IgG1) antibody-drug conjugate which target BCMA, a protein on the surface of myeloma cells. Data has shown strong responses to this treatment.
    Principal Investigator: Clifton Mo, MD