Overview
Navigating Treatment Outside of Clinical Trial Exclusion Criteria: Should This Transplant-Ineligible Patient Receive Quadruplet Therapy for NDMM?
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Achieving a strong response to initial therapy is critical for patients with newly diagnosed multiple myeloma (NDMM), as the first remission typically lasts the longest, and patient attrition with subsequent therapies due to comorbidities, disease progression, and cumulative adverse effects from treatments is common. Given the advanced age and comorbidities common among patients with MM at diagnosis, it is crucial to administer the best available treatments upfront rather than saving them for relapse. Fortunately, the inclusion of anti-CD38 monoclonal antibodies in quadruplet regimens has led to deep and durable responses in patients with NDMM, marking a paradigm shift in this treatment setting.
However, while randomized controlled trials are the gold standard by which drug safety and efficacy are evaluated, the narrow inclusion and exclusion criteria of these studies can leave providers with questions as to whether the benefits and risks of therapy extend to the more diverse, complex patients they encounter in everyday practice. This challenge is relevant for hematologists treating NDMM in transplant ineligible patients. The exclusion of certain patient populations leaves unanswered questions as to whether older patients, as well as patients with comorbidities, may benefit from quadruplet therapy.
To help specialists weigh varied criteria in the context of individual patient characteristics, this unique educational activity allows learners to “build a patient” and receive curated evidence-based insights from Dr. Benjamin Derman on whether this complex patient should be considered for quadruplet therapy and if so, what might be done to improve tolerability. Scores of different possible scenarios are possible to consider real-world variations around age, cytogenetics, performance status, frailty, comorbidities, and patient preferences.
This activity is intended for oncologists, hematologists, pathologists, and the multidisciplinary care team who manage patients with hematologic malignancies.
Multiple myeloma (MM) is the second most prevalent blood cancer globally. According to the American Cancer Society, the 5-year survival rate for those diagnosed with MM stands at approximately 60%. Since there is currently no cure for MM, most patients will experience a relapse. Achieving a strong response to initial therapy is critical for newly diagnosed multiple myeloma (NDMM) patients, as the first remission typically lasts the longest. Fortunately, the inclusion of anti-CD38 monoclonal antibodies in quadruplet regimens has led to deep and durable responses in patients with NDMM, marking a paradigm shift in this treatment setting. These novel quadruplet regimens have markedly improved outcomes for both transplant-eligible and -ineligible patients with NDMM, and they are expected to remain the standard of care in the foreseeable future.
Measurable residual disease (MRD) has also emerged as a critical prognostic and predictive marker in the management of MM, providing valuable insights into patient outcomes and guiding therapeutic strategies. While the depth of response to treatment in MM has significantly improved with the advent of novel therapies, allowing many patients to achieve complete response, the persistence of a small but clinically significant population of myeloma cells, known as MRD, often leads to relapse, emphasizing the need for highly sensitive assays to detect and quantify these residual cells. The rapid pace of novel agents and the use of MRD in patients with NDMM has heightened the challenges for clinicians to stay up to date with the potential to positively impact clinical decision-making. Clinicians must stay abreast of the latest developments to effectively incorporate these innovations into practice, ensuring the best outcomes for patients.
Upon completion of this activity, learners will be able to:
• Analyze the role of measurable residual disease (MRD) as a prognostic and predictive marker in newly diagnosed multiple myeloma (NDMM) and its impact on patient outcomes
• Assess the latest efficacy and safety data of novel quadruplet regimens, including anti-CD38 monoclonal antibodies, for the treatment of both transplant-eligible and transplant-ineligible NDMM patients
• Create comprehensive treatment plans for NDMM patients that integrate best practices, including novel therapeutic combinations and MRD monitoring, to achieve deeper remissions and extend survival
• Analyze the role of measurable residual disease (MRD) as a prognostic and predictive marker in newly diagnosed multiple myeloma (NDMM) and its impact on patient outcomes
• Assess the latest efficacy and safety data of novel quadruplet regimens, including anti-CD38 monoclonal antibodies, for the treatment of both transplant-eligible and transplant-ineligible NDMM patients
• Create comprehensive treatment plans for NDMM patients that integrate best practices, including novel therapeutic combinations and MRD monitoring, to achieve deeper remissions and extend survival
Provided by the Academy for Continued Healthcare Learning (ACHL).
Supported by an educational grant from Janssen Scientific Affairs, LLC
Benjamin Derman, MD
Assistant Professor
Medicine, Section of Hematology/Oncology
University of Chicago
Chicago, IL
Assistant Professor
Medicine, Section of Hematology/Oncology
University of Chicago
Chicago, IL
The Academy for Continued Healthcare Learning (ACHL) requires that the faculty participating in an accredited continuing education activity disclose all affiliations or other financial relationships within 24 months (1) with the manufacturers of any commercial product(s) and/or provider(s) of commercial services discussed in an educational presentation and (2) with all ineligible companies. All relevant financial relationships have been mitigated prior to this activity.
The following financial relationships have been provided:
Benjamin Derman, MD
Consultant: Canopy, Johnson & Johnson, Sanofi
Grants/Research Support: Amgen, GlaxoSmithKline
Review Panel Member: Bristol Myers Squibb
ACHL staff members and others involved with the planning, development, and review of the content for this activity have no relevant affiliations or financial relationships to disclose.
The content for this activity was developed independently of any ineligible company. All materials are included with permission. The opinions expressed are those of the faculty and are not to be construed as those of the publisher or grantor(s).
This educational activity was planned and produced in accordance with the ACCME Standards for Integrity and Independence in Accredited Continuing Education. Recommendations involving clinical medicine in a continuing medical education (CME/CE) activity must be based on evidence that is accepted within the profession of medicine as adequate justification for their indications and contraindications in the care of patients. All scientific research referred to, reported, or used in CME/CE in support or justification of a patient care recommendation must conform to the generally accepted standards of experimental design, data collection, and analysis.
This CME/CE activity might describe the off-label, investigational, or experimental use of medications and/or devices that may exceed their FDA-approved labeling. Physicians should consult the current manufacturers’ prescribing information for these products. ACHL requires the speaker to disclose that a product is not labeled for use under discussion.
Discussion of scientific information on unapproved uses (SIUU), off-label, investigational, or experimental drug/device use: None
This activity will take up to 75 minutes to complete. To receive credit, learners are required to complete the pretest, view the online activity, and complete the posttest and evaluation. To receive credit, 75% must be achieved on the posttest. A certificate will be immediately available. There is no fee to participate in the activity or for the generation of the certificate.
The Academy for Continued Healthcare Learning is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
The Academy for Continued Healthcare Learning designates this enduring material for a maximum of 1.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Physician assistants, nurse practitioners, and nurses may participate in this educational activity and earn a certificate of completion as AAPA, AANP, and ANCC accept AMA PRA Category 1 Credits™ through their reciprocity agreements.
