(BPT) - Two clinical trials are seeking adults for research on an investigational medicine for relapsed and/or refractory multiple myeloma.
Multiple myeloma is a rare bone marrow cancer, and about 35,000 people in the United States will be diagnosed this year.[1],[2] Most people will be diagnosed over the age of 65, and African Americans are more than twice as likely to be diagnosed compared to Caucasian patients.[3] Multiple myeloma can cause a range of difficult symptoms, from bone pain and infections, to weakness, nerve damage, or impaired kidney function.[4]
While there are treatments approved for multiple myeloma, most people will have their cancer return after treatment (what doctors call 'relapse') or they may no longer respond to a certain medicine (called 'refractory' disease).[5],[6] Doctors may determine suitable treatments for each patient based on a range of factors, including the stage of the disease and previous therapies, as different treatments may be combined or used one after another.[7]
Bristol Myers Squibb is currently investigating the potential of an investigational therapy for patients living with relapsed or refractory multiple myeloma.
Evaluating an investigational treatment option for multiple myeloma:
Medical research built on existing scientific knowledge and proven mechanisms of disease have the potential to improve anti-myeloma activity and overcome treatment resistance.
Clinical trials are controlled studies of potential new medicines, procedures or other treatments, and doctors use information they learn from these studies to help figure out new or improved ways to treat diseases like multiple myeloma. While clinical trials offer the possibility of accessing cutting-edge treatments and contributing to medical advancements, they also come with potential risks, including side effects and uncertainties about the effectiveness of the treatment being studied.
Two clinical trials are underway evaluating an oral therapy called mezigdomide, which is part of a group of novel therapies known as CELMoDs™. CELMoDs, like mezigdomide, have been designed to help remove harmful proteins from cells, potentially killing cancerous myeloma cells and helping the body's immune system to attack these cells as well.
'Despite continued scientific progress, multiple myeloma is still incurable, and many people have periods of remission followed by relapse, making the long-term management of this cancer incredibly important,' said Anne Kerber, M.D., Senior Vice President and Head of Late Clinical Development, Hematology, Oncology and Cell Therapy for Bristol Myers Squibb. 'Having many different medicines available for people as they live with this cancer is necessary for the future of myeloma therapy and clinical trials are critical in helping us find the next wave of potential treatment approaches. People who take part in clinical trials play a vital role in how we advance research for this disease and, ultimately, improve outcomes.'
About the SUCCESSOR-1 and SUCCESOR-2 studies:
The SUCCESSOR-1 and SUCCESSOR-2 studies are studying the safety, tolerability, and effectiveness of mezigdomide in combination with other myeloma treatments, compared to standard medicines for multiple myeloma without mezigdomide in adults with relapsed and/or refractory multiple myeloma.[8],[9],[10],[11]
Before joining a SUCCESSOR trial, patients sign their consent, then take part in a screening period, during which a doctor performs several tests and assessments to see if they are eligible to participate in the study. For both SUCCESSOR studies, eligible participants must be at least 18 years of age, have a diagnosis of progressive multiple myeloma, and have received prior treatment for multiple myeloma with certain medicines. After all necessary tests and assessments have been completed, and if patients are eligible to take part, they may enter the study assigned and will be randomized to receive standard multiple myeloma treatment or standard multiple myeloma treatment with mezigdomide. Participation in a clinical trial is voluntary. Once study treatment begins, it will continue until the disease returns or the treatment is stopped for another reason, such as issues with tolerability. There are also follow-up visits to assess the long-term effectiveness and safety of the therapy.
During the study, patients would not be responsible for study-related costs, such as doctor visits, lab tests and procedures. Those costs are all covered by Bristol Myers Squibb. Patients and caregivers may also be able to receive reimbursement for some costs like time, travel, or transportation.
If interested in learning more about the SUCCESSOR trial program, patients should talk to their doctor to decide if taking part is right for them. Visit the BMS Clinical Trials website for more information.
[1] Hansen JD, Correa M, Nagy MA, et al. Discovery of CRBN E3 ligase modulator CC-92480 for the treatment of relapsed and refractory multiple myeloma. J Med Chem. 2020;63(13):6648-6676. doi:10.1021/acs.jmedchem.9b01928. Accessed September 2024.
[2] American Cancer Society. Cancer Facts & Figures 2024. American Cancer Society. https://www.cancer.org/research/cancer-facts-statistics/all-cancer-facts-figures/2024-cancer-facts-figures.html. Published January 2024. Accessed September 2024.
[3] American Cancer Society. Multiple Myeloma Causes, Risk Factors and Prevention. American Cancer Society. https://www.cancer.org/cancer/types/multiple-myeloma/causes-risks-prevention/risk-factors.html. Published January 2024. Accessed September 2024.
[4] American Cancer Society. Signs and Symptoms of Multiple Myeloma. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/detection-diagnosis-staging/signs-symptoms.html. Published February 2018. Accessed September 2024.
[5] Cancer Treatment Centers of America. Multiple myeloma relapse. Cancer Treatment Centers of America. https://www.cancercenter.com/cancer-types/multiple-myeloma/types/relapsed-multiple-myeloma. Published June 2023. Accessed September 2024.
[6] Yang WC, Lin SF. Mechanisms of Drug Resistance in Relapse and Refractory Multiple Myeloma. Biomed Res Int. National Library of Medicine. https://pubmed.ncbi.nlm.nih.gov/26649299/. doi:10.1155/2015/341430. Published November 2015. Accessed September 2024.
[7] Multiple Myeloma Treatments | Drugs & Treatment by Stage. MMRF. https://themmrf.org/diagnosis-and-treatment/treatment-options/#:~:text=The%20choice%20of%20initial%20treatment Accessed September 2024.
[8] Richardson PG, Badelita S, Besemer B, et al. A phase 3, two-stage, randomized study of mezigdomide, bortezomib, and dexamethasone versus pomalidomide, bortezomib, and dexamethasone in relapsed/refractory multiple myeloma: SUCCESSOR-1. Poster presented at: 11th Annual Meeting of the Society for Hematologic Oncology (SOHO); September 6-9, 2023; Houston, TX.
[9] A phase 3, two-stage, randomized, multicenter, open-label study comparing mezigdomide (CC-92480), bortezomib and dexamethasone (MeziVd) versus pomalidomide, bortezomib and dexamethasone (PVd) in subjects with relapsed or refractory multiple myeloma (RRMM): SUCCESSOR-1. ClinicalTrials.gov identifier: NCT05519085. Updated October 27, 2023. Accessed September 2024. https://clinicaltrials.gov/study/NCT05519085
[10] Richardson PG, Amatangelo M, Berenson JR, et al. A phase 3, two-stage, randomized study of mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in relapsed/refractory multiple myeloma: SUCCESSOR-2. Poster presented at: Annual Meeting of the American Society of Clinical Oncology (ASCO); June 2-6, 2023; Chicago, IL.
[11] A phase 3, two-stage, randomized, multicenter, open-label study comparing mezigdomide (CC-92480/BMS-986348), carfilzomib and dexamethasone (MeziKD) versus carfilzomib and dexamethasone (Kd) in participants with relapsed or refractory multiple myeloma (RRMM): SUCCESSOR-2. ClinicalTrials.gov identifier: NCT05552976. Updated October 31, 2023. Accessed September 2024. https://clinicaltrials.gov/study/NCT05552976