First Patient Treated With Investigational ABBV-383 in CERVINO Phase III Study for Multiple Myeloma
Global, multicenter, randomized, open-label, parallel-group study will evaluate ABBV-383 in adult patients with relapsed/refractory multiple myeloma.
AbbVie has announced that the first patient has been treated with its investigational ABBV-383 in the CERVINO Phase III study (NCT06158841). The trial is a global, multicenter, randomized, open-label, parallel-group study evaluating the investigational therapy in adult patients with relapsed/refractory multiple myeloma who received at least two lines of prior therapy.1
According to AbbVie, ABBV-383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.
"Despite notable advances in treatment, most patients with multiple myeloma will eventually relapse. Patients with advanced disease, especially in the community setting, often have limited access to novel treatment options and existing options have a high treatment burden, including frequent dosing," Peter Voorhees, MD, clinical professor of medicine, director of plasma cell disorders, Atrium Health Levine Cancer Institute said in a press release "The CERVINO Phase III trial is designed to evaluate the efficacy of ABBV-383 with monthly dosing and we look forward to seeing the data as it emerges."
The dual primary end points for the study are progression-free survival and overall response rate. Secondary end points include overall survival, complete response (CR) or better, very good partial response or better, rate of minimum residual disease negativity, and change in disease symptoms and physical functioning. Approximately 140 sites are expected to enroll approximately 380 total patients.
In 2024, an estimated 35,780 cases of multiple myeloma will be diagnosed (19,520 in men and 16,260 in women).2
"The start of the CERVINO Phase III trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients," Mariana Cota Stirner, MD, PhD, vice president, therapeutic area head oncology, hematology, AbbVie said in the press release. "ABBV-383 is being evaluated with monthly dosing from the beginning of treatment, with the goal of maximizing treatment simplicity for physicians and patients, if proven in the clinical trials."
References
1. AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383. News release. June 5, 2024. Accessed June 7, 2024. https://www.prnewswire.com/news-releases/abbvie-advances-oncology-pipeline-with-start-of-multiple-myeloma-phase-3-clinical-trial-for-investigational-asset-abbv-383-302164808.html
2. Key Statistics About Multiple Myeloma. American Cancer Society. Updated January 19, 2024. Accessed June 7, 2024. https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
