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Clinical

Karen M. Winkfield, MD, PhD; Narjust Florez, MD, FASCO; Gilberto de Lima Lopes Junior, MD, MBA, FASCO; Coral Olazagasti, MD; Vonetta M. Williams, MD, PhD

 Fighting Disparities and Saving Lives: An Exploration of Challenges and Solutions in Cancer Care

JAN-22-TTD0607 - /clinical/multiple-myeloma-rc

In this episode of Targeted Talks, ​​Binod Dhakal, MD, MS, assistant professor of medicine in the Division of Hematology and Oncology at the Medical College of Wisconsin, discusses the recent FDA approval of ciltacabtagene autoleucel (cilta-cel; Carvytki) for the treatment of patients with relapsed/refractory multiple myeloma that has been treated with at least 1 prior line of therapy, including a proteasome inhibitor and immunomodulatory agent and is refractory to lenalidomide. (Revlimid).

Cilta-cel is a chimeric antigen receptor (CAR) T-cell therapy that was previously granted approval by the FDA 

in February 2022 for patients with relapsed/refractory multiple myeloma

 who had received at least 4 prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 antibody.3

 for patients with multiple myeloma who have received at least 1 prior line of therapy and are refractory to lenalidomide based on findings from the phase 3 CARTITUDE-4 study (NCT04181827).1 The study showed that the median progression-free survival (PFS) at a median follow-up of 15.9 months (range, 0.1-27.3) was not reached in the cilta-cel arm compared with 11.8 months in the standard-of-care (SOC) arm (HR, 0.26; 95% CI, 0.18-0.38; 

 <.001). At 12 months, the PFS rates were 75.9% (95% CI, 69.4%-81.1%) vs 48.6% (95% CI, 41.5%-55.3%) in the cilta-cel vs SOC arms, respectively.2

“I think the approval of this in that indication is really kind of an important milestone, and really helps in improving the outcomes for these patients,” says Dhakal.

1. Carvykti is the first and only BCMA-targeted treatment approved by the US FDA for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. News release. Johnson & Johnson. April 5, 2024. Accessed June 12, 2024. 

2. San-Miguel J, Dhakal B, Yong K, et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. N Engl J Med. 2023;389(4):335-347. doi:10.1056/NEJMoa2303379

In this episode of Targeted Talks, Binod Dhakal, MD, MS, discusses the recent FDA approval of ciltacabtagene autoleucel for the treatment of relapsed/refractory multiple myeloma.

Dhakal Reflects on the FDA Approval of Cilta-Cel for Earlier Lines of RRMM

In season 5, episode 3 of Targeted Talks, Ben Derman, MD, assistant professor of medicine at the University of Chicago Medical Center, dissects the latest advancements in myeloma treatment, focusing on the role of ClonoSeq and minimal residual disease (MRD) monitoring.

Specifically, the discussion delves deep into the game-changing trial (NCT02969837) investigating MRD in the peripheral blood of patients with multiple myeloma. An analysis of the study recently evaluated the concordance and prognostic significance of early MRD status after 4 cycles of treatment with elotuzumab (Empliciti), carfilzomib (Kyprolis), lenalidomide (Revlimid), and dexamethasone (Elo-KRd) by next-generation sequencing in the bone marrow and peripheral blood and by International Myeloma Working Group response criteria. Findings were presented at the 2023 American Society of Hematology Annual Meeting.

"Peripheral blood testing, while not as sensitive as bone marrow, could offer a less invasive alternative for patients, potentially guiding treatment decisions more effectively," Derman explains.

The trial employed an MRD-adapted design to determine the duration of carfilzomib treatment based on MRD status, demonstrating a personalized treatment approach guided by MRD assessment.

Pivotal findings from this trial showed the association of peripheral blood MRD status with progression-free survival (PFS). Patients with peripheral blood MRD positivity exhibited inferior PFS outcomes compared with those with peripheral MRD negativity. The strong correlation between bone marrow and peripheral blood MRD status indicates the potential utility of peripheral blood MRD testing as a reliable indicator of disease burden and treatment response.

These findings underscore the transformative potential of peripheral blood MRD testing in the management of multiple myeloma, paving the way for personalized treatment strategies and improved patient outcomes.

Gain more insights into the exciting advancements in MRD detection, including next-generation sequencing and mass spectrometry, offering patients a less invasive alternative for monitoring disease progression in this episode.

Derman BA, Kubicki T, Simmons H, et al. Early peripheral blood minimal residual disease status by NGS in patients with newly diagnosed multiple myeloma (mm) on a phase 2 trial receiving elotuzumab, carfilzomib, lenalidomide, and dexamethasone (Elo-KRd). 

 2023;142(Suppl 1):1982. doi:10.1182/blood-2023-182410

In this episode of Targeted Talks, Ben Derman, MD, dissects the latest advancements in myeloma treatment, focusing on the role of ClonoSeq and minimal residual disease monitoring.

Advancing Myeloma Treatment With Blood-Based MRD Testing

In a Community Case Forum in partnership with the North Carolina Oncology Association, Cristina Gasparetto, MD, discussed the CEPHEUS, IMROZ, and BENEFIT trials of treatment for transplant-ineligible newly diagnosed multiple myeloma. 

Gasparetto Explains Rationale for Quadruplet Front Line in Transplant-Ineligible Myeloma

Peers & Perspectives in Oncology editorial board member Marc J. Braunstein,
MD, PhD, FACP, discussed the significant advancements in multiple myeloma
treatment at the 2024 ASH Annual Meeting and Exposition. 

Key Trials From ASH 2024 Impact Treatment for Plasma Cell Disorders Going Forward

The FDA granted orphan drug designation to OPN-6602 for the potential treatment of relapsed/refractory multiple myeloma.

FDA Grants OPN-6602 Orphan Drug Status in R/R Myeloma

Idecabtagene vicleucel induced high complete response and minimal residual disease negativity rates in multiple myeloma after suboptimal first-line therapy.

Idecabtagene Vicleucel Shows Strong Response in Multiple Myeloma

Binod Dhakal, MD, MS, discussed the use of bispecific antibodies and chimeric antigen receptor T-cell therapy in relapsed/refractory multiple myeloma treatment.

Navigating the Use of Bispecific Antibodies and CAR T-Cell Therapy in RRMM

CARTITUDE-4 Highlights: Cilta-Cel vs Standard of Care in R/R MM

Videos

Panelists discuss how CARTITUDE-4 demonstrated superior progression-free survival and overall response rates with ciltacabtagene autoleucel  (cilta-cel) compared with standard treatment options in relapsed/refractory multiple myeloma (R/R MM) patients who received 1 to 3 prior lines of therapy.

Video Series

Strategies to Overcome CAR T Roadblocks in the Real-World Practice Setting

Panelists discuss how to address practical challenges in delivering chimeric antigen receptor (CAR) T cell therapy, including patient selection, bridging therapy, manufacturing delays, access barriers, and coordination of care to optimize real-world outcomes.

Patient Case 4: A 38-Year-Old Woman With Functional High-Risk MM With Progressive Disease at Day 60 Post ASCT—Next Treatment Approaches

Panelists discuss how to manage an aggressive case of early posttransplant progression in a young woman with functionally high-risk multiple myeloma (MM), focusing on rapid intervention strategies and novel therapeutic approaches to overcome poor prognosis disease.

Patient Case 4: A 58-Year-Old Woman With High-Risk MM Post HSCT With Progressive Disease—What Are Next Steps?

Panelists discuss how to approach treatment selection and sequencing for a 58-year-old woman with high-risk multiple myeloma (MM) who has developed progressive disease after stem cell transplantation, considering factors such as prior therapy exposure, available options, and disease biology.

Exploring Maintenance Strategies Post Autologous Transplant

Panelists discuss how to optimize maintenance therapy following autologous stem cell transplantation by evaluating factors such as duration, drug selection, and risk-adapted approaches to maximize long-term outcomes in multiple myeloma patients.

Clinical Perspectives: Question to Start Asking Is Who Not to Give Quadruplet CD38-Containing Regimens in Transplant-Eligible NDMM

Panelists discuss how the paradigm in transplant-eligible newly diagnosed multiple myeloma (NDMM) has shifted to considering which patients should not receive quadruplet CD38-containing regimens rather than who should, given the compelling efficacy data supporting this approach.

The panelist discusses how for managing patients with R/R multiple myeloma, community clinicians should focus on personalized treatment approaches, incorporating novel therapies such as CAR T-cell therapy while carefully monitoring for and managing toxicities through established protocols. Key considerations include implementing systematic toxicity management strategies, maintaining long-term patient monitoring, and staying informed about emerging therapeutic options. The field is evolving with promising novel agents and combination approaches being investigated, particularly for patients who progress after initial treatments.

Managing R/R Multiple Myeloma: Current Strategies and Future Directions in Community Practice

Video content above is prompted by the following:

What are the key strategies that community-based clinicians can leverage to effectively manage and support patients with R/R multiple myeloma?

What toxicity mitigation strategies would you consider for patients who receive CAR T for 3L R/R multiple myeloma?

What recommendations can you share for community providers on long-term monitoring of CAR T in patients with R/R MM?

What is the future for the treatment of R/R multiple myeloma?

What novel therapeutic strategies or combination approaches are being investigated for patients with multiple myeloma who progress beyond early lines of therapy?

Case Based Peer Perspectives

Future Directions After AURIGA: Daratumumab and Lenalidomide in Myeloma

Ashraf Z. Badros, MB, ChB, professor of medicine, director of the Multiple Myeloma Service, and vice chair of the Clinical Research Committee for the Program in Oncology at the University of Maryland School of Medicine in Baltimore, discusses the next steps following the phase 3 AURIGA trial (NCT03901963) of daratumumab (Darzalex) and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma.



I think the trial really establishes the addition of daratumumab, not only to induction and consolidation, which are now standard of care, as shown by trials like GRIFFIN [NCT02874742] and PERSEUS [NCT03710603] supporting its use in newly diagnosed patients, but also as maintenance with lenalidomide to prolong or improve MRD negativity. The definitive trial will likely be conducted and reported by SWOG, which randomizes patients between daratumumab and lenalidomide vs lenalidomide alone after transplant. This trial will include patients who received daratumumab during induction. There will also be a second randomization after 2 years for patients who are MRD-negative to see if they can go on observation or continue with maintenance.

 The next step will likely be using MRD to guide the duration of treatment. As you know, the FDA has approved MRD, and the Oncologic Drugs Advisory Committee voted in favor of using MRD as a surrogate end point in myeloma trials, which will help with accelerated approval. For us as clinicians, the next step is going to be to use MRD data to guide treatment duration. Right now, we don’t have clear data on when to stop, but at a minimum, treatment might be stopped after 2 to 3 years. Some people would consider stopping maintenance treatment, especially in standard-risk patients, while high-risk patients and those with high-risk cytogenetics might require continuous treatment due to the higher risk of progression.

Badros AZ, Foster L, Anderson LD Jr, et al. Daratumumab with lenalidomide as maintenance after transplant in newly diagnosed multiple myeloma: the AURIGA study. 

. Published online September 27, 2024. doi:10.1182/blood.2024025746

Ashraf Z. Badros, MB, ChB, discusses the next steps following the phase 3 AURIGA trial of daratumumab and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma.


News

PERSEUS Trial Highlights: Dara-VRd vs VRd in Transplant-Eligible NDMM

Panelists discuss how the PERSEUS trial demonstrated superior progression-free survival with daratumumab-VRd compared to VRd alone in patients with transplant-eligible newly diagnosed multiple myeloma (NDMM), potentially establishing a new standard of care in this setting.

Selecting Among Guideline Recommended Treatment Options in Transplant-Eligible NDMM

Panelists discuss how to navigate and choose among multiple guideline-recommended induction regimens for patients with transplant-eligible newly diagnosed multiple myeloma (NDMM) by considering factors such as efficacy data, toxicity profiles, and individual patient characteristics.

Samer Al'Hadidi discusses resources for relocation of patients needing CAR T-cell therapy

Providing Resources for Relocation Expands CAR T Access in Relapsed Refractory Multiple Myeloma

Samer A. Al’Hadidi, MD, assistant professor in the Department of Internal Medicine — Division of Hematology and Oncology at UAMS Winthrop P. Rockefeller Cancer Institute in Little Rock, Arkansas, discusses social determinants and resources that can help patients receive chimeric antigen receptor (CAR) T-cell therapy for relapsed/refractory multiple myeloma (RRMM).

During a Case-Based Roundtable event, Al’Hadidi said he heard concerns from other oncologists about patients needing support to be treated with CAR T-cell therapy. Patients who already live near a CAR T-cell center don’t face major issues, but those who live further away face challenges because they need to remain close to the center for 4 to 5 weeks for monitoring.

Al’Hadidi said that there are resources being offered to patients and their families who need to relocate temporarily, such as covering expenses of lodging and food as well as other support. His institution and others have recognized that these barriers are keeping patients from relocating. He added that this discussion was beneficial to the participants as some were surprised to know these resources may be available, which could change how they consider patients for referral to receive CAR T cells.

 I think one of the things that was discussed is focusing on the social determinant of offering those CAR T-cell therapy. There were some concerns about the support that patients may get during this process. I think that is variable according to where the patient who has been referred is located in regards to the CAR T Center. For patients who are living close to the CAR T Center, I don't think this major issue is there, but for patients who need to relocate for the duration of around 4 to 5 weeks to do the CAR T cell therapy, there was some discussions on how to actually optimally do that.

I think we did actually discuss some resources that are being offered to patients and their families, including lodging expenses being covered, along with also some food allowance and other things that could have helped patients to get this product, because we realized that there [is] a cost on patients that we need to kind of help them cover to be able to relocate to do those CAR T-cell therapies. I think this was a very fruitful sort of discussion, because for some of the community oncologists, they were surprised to know that such things could have been possible for patients and that may make it easier to consider for some patients.

Samer A. Al’Hadidi, MD, discusses social determinants and resources that can help patients receive chimeric antigen receptor T-cell therapy for relapsed/refractory multiple myeloma.

Providing Resources for Relocation Expands CAR T Access in RRMM

Samer A. Al’Hadidi, MD, discusses the follow-up data for ciltacabtagene autoleucel in patients with multiple myeloma.

Considering 3-Year Follow-Up Data of Cilta-Cel in Multiple Myeloma

Samer A. Al’Hadidi, MD, assistant professor in the Department of Internal Medicine — Division of Hematology and Oncology at UAMS Winthrop P. Rockefeller Cancer Institute in Little Rock, Arkansas, discusses the follow-up data for ciltacabtagene autoleucel (cilta-cel; Carvykti) in patients with multiple myeloma.

During a Case-Based Roundtable event, Al’Hadidi reviewed the 3-year follow-up data of CARTITUDE-4 trial (NCT04181827). Patients on the trial experienced superior progression-free survival (PFS), overall survival (OS), and duration of response with cilta-cel vs standard of care (SOC). Al’Hadidi also notes that there are still two-thirds of patients responding to cilta-cel compared with one-third with SOC.

MULTIPLE MYELOMA

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