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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

During a live event, Jack Khouri, MD, discussed options for patients with multiple myeloma after relapse and choices to consider before CAR T-cell therapy.

Optimizing CAR T-Cell Therapy Prep in Multiple Myeloma After Relapse

Melphalan flufenamide (melflufen) is approved in Europe for relapsed/refractory multiple myeloma, but the FDA withdrew its approval of the treatment last year. 

Italian Study Highlights Real-World Data for Melphalan Flufenamide in Myeloma

John M. Burke, MD, highlights findings from the AQUILA, DREAMM 7, and MajesTEC-5 trials in multiple myeloma. 

Promising Trials Expand Approaches Across Multiple Myeloma Settings

A real-world study has reinforced the efficacy and safety of teclistamab in heavily pretreated patients with relapsed/refractory multiple myeloma.

Real-World Study Confirms Teclistamab’s Efficacy in Heavily Pretreated RRMM, Aligning with MajesTEC-1 Findings

In a live virtual event, Attaya Suvannasankha, MD, discussed the MajesTEC-1 trial of teclistamab and approaches to mitigation of cytokine release syndrome. 

Follow-Up With Teclistamab Shows Durability and Optimization of Dosing

Overcoming Obstacles in Prescribing High-Cost Myeloma Therapies

Hamlet Gasoyan, MD, staff investigator at the Center for Value-Based Care Research in the Department of Internal Medicine of Cleveland Clinic’s Primary Care Institute and assistant professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, discusses some of the common challenges that oncologists face when getting patients started on more costly oral treatments for multiple myeloma.


In this video, Gasoyan identifies significant systemic barriers to initiating oral multiple myeloma therapies like lenalidomide (Revlimid), emphasizing 3 key challenges:

1. Administrative complexities, including mandatory risk evaluation and mitigation strategy (REMS) program compliance, prior authorization requirements, and restricted distribution through specialty pharmacies.

2. Financial burdens requiring patients to navigate copay assistance programs.

3. Coordination gaps between stakeholders in the care pathway.

 that uncovered significant disparities in the timing of treatment initiation for patients with newly diagnosed multiple myeloma receiving oral antimyeloma medications. The study used Taussig Cancer Center's Myeloma Patient Registry to identify adults with multiple myeloma diagnosed between January 2017 through December 2021. Specifically, the research highlighted a gap in the initiation of oral medications, even as other components of multidrug regimens begin.

While their research found no disparities in treatment timing tied to social determinants of health for infused therapies, oral medications showed consistent fill delays attributable solely to these procedural hurdles.

“When examining social determinants of health, we did not find any disparities regarding the timing of obtaining facility-administered or oral medications. However, we identified factors associated with delayed prescription fills for oral medications, indicating that administrative burdens are posing challenges for patients and require further investigation,” Gasoyan explains.

Gasoyan H, Anwer F, Kovach JD, et al. Disparities in time to treatment with oral antimyeloma medications. 

. 2024;14(1):142. Published 2024 Aug 23. doi:10.1038/s41408-024-01128-1

Videos

Hamlet Gasoyan, MD, discusses some of the common challenges that oncologists face when getting patients started on more costly oral treatments for multiple myeloma.


News

Future Outlooks for CAR T in Early R/R Multiple Myeloma

Panelists discuss how chimeric antigen receptor (CAR) T-cell therapy could potentially be moved to earlier lines of treatment in relapsed/refractory multiple myeloma based on emerging trial data, improving outcomes through earlier intervention before patients develop treatment resistance.

Video Series

KarMMa-3 Trial: Additional Insights From Ide-Cel in RRMM

Panelists discuss how detailed analyses from KarMMa-3 reveal key insights about ide-cel’s performance across patient subgroups, timing of responses, durability of remissions, and management of adverse effects in relapsed/refractory multiple myeloma (RRMM).

KarMMa-3 Highlights: Ide-Cel vs Standard Regimens in Triple-Class– Exposed RRMM

Panelists discuss how the KarMMa-3 trial demonstrated superior efficacy of idecabtagene vicleucel (ide-cel) chimeric antigen receptor T-cell therapy compared to standard treatment regimens in patients with heavily pretreated, triple-class–exposed relapsed/refractory multiple myeloma (RRMM).

Ide-cel in Multiple Myeloma Post-Transplant: Insights From Garfall

Alfred L. Garfall, MD, director of Autologous Hematopoietic Stem Cell Transplantation, the section chief of Myeloma and Hematology-Oncology, and an associate professor of Medicine (Hematology-Oncology) at the Hospital of the University of Pennsylvania, Penn Medicine, in Philadelphia, discusses the phase 2 BMT CTN 1902 trial (NCT05032820) which evaluated the safety, feasibility, and effectiveness of idecabtagene vicleucel (ide-cel; Abecma), an anti-BCMA chimeric antigen receptor (CAR) T-cell therapy, in patients with multiple myeloma with suboptimal response after upfront autologous stem cell transplant.

 So, this is a clinical trial that tests the use of ide-cel, an anti-BCMA CAR T-cell product, to improve response for patients who have been through the standard intensive first-line multiple myeloma therapy and have failed to achieve a complete response. That intensive first-line therapy that these patients have been through is some form of multi-agent induction therapy, followed by consolidation with high-dose melphalan and autologous stem cell transplant, and then some period of lenalidomide-based maintenance therapy. 

That group of patients, if they after all that therapy, if they have failed to achieve a complete response, you know, that group of patients has, on average, inferior long-term outcomes. The idea was whether CAR T cells at that point, at this point in time, could convert patients to a complete response and hopefully improve their long-term outcomes.

 This was a phase 2, single-arm study that really focused on the safety and feasibility of this approach and a preliminary measure of effectiveness, which we based on the rate of conversion to complete response after 6 months after CAR T-cell infusion. The reason it was important to demonstrate initial safety and feasibility in a smaller study here is because there have not been many studies that have utilized CAR T cells early after an autologous stem cell transplant.

 We had questions about whether the T cells that you would harvest from patients early after transplant, if they could be used for CAR T-cell manufacturing in the setting where the myeloma is at a very low level, even though these patients haven't achieved a complete response, they have relatively low amounts of myeloma because of all the prior therapy they've had. And so whether CAR T cells, if they were infused into patients who had a low amount of myeloma, whether the CAR T cells really expand and have an anti-myeloma effect in this setting.

 And then, because it is a standard approach for these patients to be on long-term maintenance with lenalidomide, and at the same time, it's also common for patients after CAR T-cell therapy to have low blood counts, we wanted to make sure that it was feasible to get them back on lenalidomide maintenance therapy. Because we were concerned that, you know, when you combine the effect of the auto transplant on blood counts, and then CAR T-cell therapy on blood counts, and then lenalidomide's effect, that maybe we were concerned that we wouldn't be able—patients might not be able to resume the standard-of-care lenalidomide maintenance, which is an intervention that has been proven to prolong overall survival in [patients with] myeloma patients.

 So, a major objective of this study was to get a preliminary assessment of whether patients were able to resume lenalidomide after CAR T-cell therapy and continue the standard-of-care first-line therapy with lenalidomide maintenance.

Alfred L. Garfall, MD, discusses the phase 2 BMT CTN 1902 trial of idecabtagene vicleucel in patients with multiple myeloma.


Patient Case 5: A 66-Year-Old Patient With R/R MM With Relapse Less Than 2 Years Post ASCT—Next Steps

Panelists discuss how to select optimal therapy for a 66-year-old patient with early relapse following autologous stem cell transplantation (ASCT), considering factors such as prior treatment exposure, duration of response, and emerging therapeutic options including cellular therapies.

CARTITUDE-4: Navigating Late CAR-T Toxicities

Panelists discuss how to identify, monitor, and manage delayed toxicities following ciltacabtagene autoleucel (cilta-cel) chimeric antigen receptor (CAR) T therapy, including prolonged cytopenias, infections, and neurotoxicity, to optimize long-term patient outcomes and safety.

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

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.

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.

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.

MULTIPLE MYELOMA

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