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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

Bispecific antibody therapy is transforming cancer treatment, especially in multiple myeloma, with ongoing studies exploring early-line and maintenance use.

Emerging BsAbs and Their Impact in Multiple Myeloma

During a Case-Based Roundtable® event, Rahul Banerjee, MD, discussed approaches to dosing and tolerability when using talquetamab in patients with relapsed/refractory multiple myeloma. 

Banerjee Discusses Dose De-Escalation and GPRC5D Toxicity Management in RRMM

The phase 3 IRAKLIA trial of subcutaneous isatuximab met its co-primary end points in multiple myeloma.

Subcutaneous Isatuximab Combo Hits Primary End Points in Phase 3 Trial

During a Case-Based Roundtable® event, Hira Shaikh, MD, and participants discussed how they would treat a patient with lenalidomide-refractory multiple myeloma after 1 prior line of therapy.

Peers Evaluate CAR T Referral and Bridging Process for Early Relapsed Multiple Myeloma

In separate, live events, Binod Dhakal, MD, MS; and Laahn H. Foster, MD, polled oncologists on therapeutic options for a patient with multiple myeloma and progressive disease.

Roundtable Roundup: Choosing a Bispecific Antibody for R/R Multiple Myeloma 

Behind the Phase 3 AURIGA Trial in Newly Diagnosed Multiple 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 background, methods, and design of the phase 3 AURIGA trial (NCT03901963).


The phase 3 AURIGA study evaluated daratumumab (Darzalex) and lenalidomide vs lenalidomide maintenance in patients with newly diagnosed multiple myeloma who were in very good partial response, minimal residual disease (MRD)-positive, and anti-CD38 naive post-transplant.

The primary end point was the percentage of patients with MRD-negative Status as determined by next-generation sequencing. Secondary end points included progression-free survival, percentage of patients with overall MRD-negative status, durable MRD-negative rate, percentage of patients achieving complete response (CR) or stringent CR, overall survival, duration of CR, change in health-related quality of life, safety, and tolerability.

The AURIGA trial is the first trial to directly compare the addition of daratumumab to lenalidomide vs lenalidomide, which is the standard of care for maintenance after transplant and [patients with] multiple myeloma.

 The study is a randomized phase 3 trial conducted in the US and Canada. It included patients who had received a minimum of 4 cycles of induction that did not include an anti-CD38 antibody (so no daratumumab or isatuximab) followed by a transplant within 12 months. Patients should have been in [very good partial response] or better after the transplant and were MRD-positive by next-generation sequencing at the 10-5 threshold.

Patients were stratified by cytogenetic risk and randomized within 6 months of transplant to either daratumumab and lenalidomide vs lenalidomide alone. Treatment was administered for 36 months. MRD testing was done at 12, 18, 24, and 36 months. The primary end point of the study was MRD-negative conversion rate at 10-5 after 12 months of maintenance.

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

Videos

Ashraf Z. Badros, MB, ChB, discusses the background, methods, and design of the phase 3 AURIGA trial.

News

The panelist discusses how the treatment landscape for early-stage relapsed/refractory multiple myeloma (R/R MM) has evolved significantly with CAR T-cell therapies (idecabtagene vicleucel, ciltacabtagene autoleucel [ide-cel, cilta-cel]) and novel drug combinations. Treatment selection now considers prior therapies, patient characteristics, and response duration. For third-line chimeric antigen receptor (CAR) T after no prior CAR T use, cilta-cel shows favorable efficacy data with deeper, more durable responses than ide-cel, though both are viable options.

Evolving Paradigms, CAR T, and Treatment Selection in Early-Stage R/R MM

Video content above is prompted by the following:

How has the treatment landscape evolved for patients with early-stage R/R MM?

How has the evolving paradigm affected your approach to treatment selection and sequencing in early-stage R/R MM?

For patients not previously treated with CAR T in the second line (2L), what choice of CAR T therapy would you consider in the 3L setting?

What factors inform your selection of CAR T beyond the 2L setting in MM?

What lessons have you learned from bridging therapy, and how would you advise on optimal strategies?

Video Series

Case Based Peer Perspectives

The panelist discusses how the patient had triplet therapy 6 years ago, which was the standard for myeloma treatment at the time. Since then, the patient has had a biochemical relapse, renal insufficiency, and moderate anemia, so he needs therapy but not immediate therapy. 

A 70-Year-Old Man with Early Relapsed/Refractory Multiple Myeloma

Please share your initial impressions of the patient case.

A decision to switch therapy was made. What regimen are you most likely to recommend for this patient?

How do you set a patient up for the best success in early-stage R/R MM?

Diving Deep Into the CEPHEUS Trial: Subcutaneous Dara-VRd vs VRd in  Transplant-Ineligible or Transplant-Deferred NDMM

Panelists discuss how the CEPHEUS trial demonstrates the comparative efficacy and safety of subcutaneous daratumumab combined with VRd vs VRd alone in patients with transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma, highlighting key outcomes and clinical implications.

Evaluating Guideline-Recommended Treatment Options for Transplant-Ineligible or Transplant-Deferred NDMM

Panelists discuss how guideline-recommended treatment regimens for patients with transplant-ineligible or transplant-deferred newly diagnosed multiple myeloma should be evaluated and selected based on patient characteristics, efficacy data, and safety profiles to achieve optimal outcomes.

ASH 2024: IVIG Use With Bispecific Antibodies

Panelists discuss how intravenous immunoglobulin (IVIG) therapy may reduce infection risk in patients with multiple myeloma who are receiving teclistamab treatment.

Lessons From CARTITUDE-4: ASH 2024

Panelists discuss how minimal residual disease assessment demonstrates superior depth of response with ciltacabtagene autoleucel compared with standard of care in patients who have lenalidomide-refractory multiple myeloma and received 1 to 3 prior therapies.

Systemic Review/Meta-Analysis From ASH 2024

Panelists discuss how adding a fourth drug (daratumumab) to standard triplet induction therapy may improve outcomes for patients with newly diagnosed, transplant-eligible multiple myeloma.

Examining the AQUILA Trial Presented at ASH 2024

Panelists discuss how the AQUILA trial evaluated whether daratumumab monotherapy provides superior outcomes compared with active monitoring in high-risk smoldering multiple myeloma patients.

Clinical Insights: Starting with a Patient Case 1: 74yo 74-Year-Old Patient With NDMM Transplant- Ineligible NDMM

Panelists discuss how to approach treatment decisions for a 74-year-old patient with transplant-ineligible  newly diagnosed multiple myeloma patient, considering factors such as age, comorbidities, and available therapeutic options to develop an optimal care plan.

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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