A Historic Turning Point: ODAC Unanimously Votes in Favor of MRD Testing as an Early Endpoint in Myeloma Clinical Trials to Support Accelerated Approvals of New Treatments

In this week’s blog, IMF Chief Scientific Officer Dr. Brian G.M. Durie discusses the details and outcome of the recent April 12th Oncologic Drugs Advisory Committee (ODAC) meeting on “the use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials, including considerations regarding timing of assessment, patient populations, and trial design for future studies that intend to use MRD to support accelerated approval of a new product or a new indication.” The ODAC convened “to discuss the adequacy of available data to support the use of minimal residual disease (MRD) as an endpoint to support accelerated approval of new therapies for patients with multiple myeloma.” The IMF and collaborative research group i2TEAMM (International Independent Team for Endpoint Approval of Myeloma MRD) were at front and center of the proceedings as one of the applicants. The ODAC panelists voted unanimously in favor of MRD testing as an early endpoint in MM trials (12-0). This was a historic unanimous vote that accepts MRD-negative Complete Response (CR) as a reliable early endpoint— a turning point in myeloma clinical trials, as the bar has been set higher with deep responses as the endpoint of trials and with MRD-negative CR as the new standard for CR. While we await the FDA’s final decision, Dr. Durie is confident that this historic turning point will move the IMF steadily towards much more improved outcomes and a potential cure for multiple myeloma. 

Register Now for a Virtual Regional Community Workshop on May 21

Join this Virtual Regional Community Workshop on Tuesday, May 21, at 2:30 p.m. PT | 3:30 p.m. MT |4:30 p.m. CT | 5:30 p.m. ET. IMF Chief Medical Officer Joseph Mikhael, MD, M.Ed., FRCPC, FACP, (TGen, City of Hope—Phoenix) will discuss multiple myeloma basics, its common symptoms and side effects, advances in initial myeloma diagnosis, the stages of myeloma treatment, induction therapy, transplant, and more. IMF Nurse Leadership Board Member Kimberly Noonan, DNP, ANP-BC, AOCN, (Dana-Farber Cancer Institute—Boston) will discuss how patients can manage myeloma-related symptoms and side effects as well as the side effects brought on by treatment. David Vesole, MD, PhD, FACP, (John Theurer Cancer Center, Hackensack University Medical Center—Hackensack, NJ) will cover the types of relapsed disease, what doctors consider when selecting a treatment regimen, relapsed/refractory treatment options, how doctors treat triple and penta-class refractory myeloma, updates on clinical trials, and more. After each presentation with the experts, attendees will have ample time to ask questions. You don’t want to miss this informative session.

Case Studies for Nurses: New Therapies and Regimens for Patients with Multiple Myeloma

On April 25th at 12:15 p.m. EST, join members of the IMF’s Nurse Leadership Board in Washington, D.C. at the Oncology Nursing Symposium (ONS), as we explore the latest in multiple myeloma management! In this 1.5 CNE symposium, four highly experienced nurses will share the most up-to-date strategies for achieving deep treatment responses, managing side effects, overcoming disparities, and fostering shared decision-making. This dynamic event features real-life patient cases to highlight clinical pearls and practical solutions for nurses at all levels. Elevate your practice and empower your patients with the knowledge gained at this symposium.

This activity is intended for nurses engaged in the care of patients with multiple myeloma.

Download the 2024 Spring Edition of Myeloma Today

The spring edition of Myeloma Today is filled with promising developments in the field of myeloma.

Here are some highlights: Two New FDA Approvals: Abecma® and Carvykti® CAR T-cell therapies have been approved for earlier use in the myeloma journey, expanding treatment options and improving patient outcomes. Read about interim analyses from clinical trials of combination therapies with Blenrep® demonstrating positive results in progression-free survival. Learn about the newly granted accelerated approval by the FDA for Elrexfio, a BCMA-directed CD3 T-cell engager, for the treatment of relapsed or refractory myeloma.

Also, this edition spotlights IMF's global campaign, Myeloma ACTION Month, which was a huge success as it reached over 52 million people in 36 countries. Finally, find out how you can get involved in advocating for increased cancer research funding and making a difference in the lives of myeloma patients. Download a pdf of this edition now!

Download the New IMF Publication:
Understanding Elrexfio™ (elranatamab-bcmm)

In August 2023, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Elrexfio™ (elranatamab-bcmm) for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least 4 prior lines of therapy. Elrexfio is a B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, an immunotherapy that employs a patient’s own immune system to attack and kill their myeloma cells. Download the new IMF publication to learn more about this drug’s use in the treatment of multiple myeloma.

Announcing the Inaugural Iceland Cycling Expedition! 

The Iceland Cycling Expedition (ICE) is a fundraising bike tour taking place in beautiful Iceland with a team of twelve cyclists. From August 29, 2024, to September 3, 2024, 12 intrepid individuals will embark on an adventure across Iceland to support the Black Swan Research Initiative, including the iStopMM Research Project in Iceland. While spots for participating in this year’s expedition are full, you can still seize this opportunity to be a part of something greater. Support the thrill of adventure while being a change agent. Donate to this initiative today! 

Around the Web: Myeloma News

To keep you abreast of the most recent myeloma research findings, “The Myeloma Minute” features links to top myeloma content around the web. This article in Haematologica discusses “CD38 expression by plasma cells in extramedullary multiple myeloma.” From Blood Advances, the article “CD4+ CAR-T cell exhaustion associated with early relapse of multiple myeloma after BCMA CAR-T” comments on relapse after CAR T-cell therapy.

Be sure to check out last month’s wrap-up: March 2023 – Myeloma News from the Journals. As always, we invite you to visit the IMF Newsroom for the most recent myeloma news.

#ASKDRDURIE | Dr. Durie's Weekly Web Video Series

What are CRAB and pre-CRAB criteria in myeloma diagnosis, and how do they affect treatment decision-making?