Trial to Assess Real-World Outcomes for Patients With R/R Multiple Myeloma Treated With Isatuximab in Progress

Elisabet Manasanch, MD

An ongoing study (NCT05053607) aims to assess the real-world experience of patients with relapsed/refractory multiple myeloma (RRMM) being treated with standard-of-care isatuximab-irfc (Sarclisa) and provide digital health coaching to patients, according to a presentation of the ongoing trial and its preliminary demographics at the 19th International Myeloma Society (IMS) meeting.¹

According to a poster presentation at IMS, clinicians will look at these real-world data by collecting data from patient-reported outcomes, qualitative data, clinical and demographic data, and wearable data. During data collection, consented patients will be enrolled in 3 months of digital health coaching looking at outcomes such as their experience of treatment and adherence, quality of life, financial toxicity, symptom burdens, and maintain their own health.

The study is aiming to enroll 50 adult patients, defined as 18 years old or older, receiving or planning to receive active treatment with the CD38-directed monoclonal antibody isatuximab intravenously. In addition, eligible patients must have had at least 2 prior lines of therapy before their diagnosis of RRMM and have an ECOG performance score of 2 or less to engage in physical activity. Patients excluded from the trial include those who are terminally ill, defined by having 6 months or less to live, and patients transitioned to hospice. Moreover, patients receiving isatuximab subcutaneously will not be enrolled on the trial.

The primary outcome measure of the study is to see the change in the patient’s Qualitative Assessment of Treatment–Real World (PQAT-RW) survey and change in the baseline perception of the patient’s treatment experience during the 3 months of digital health coaching. Then, in the last month of study participation, a one-time interview will be conducted to assess the experience of the individual patient related to their diagnosis, treatment, symptoms, adverse events, and overall care experience.

Patient-reported outcomes will be collected monthly with clinical data that includes treatment history, healthcare utilization, and comorbidities, along with demographic data to be collected via the electronic health record from the patient’s site of enrollment. Patients will either be enrolled at The University of Texas MD Anderson Cancer Center or University of Washington, a second location that is expected to open soon.

Patients enrolled in the trial will start with a welcome to Pack Health and digital coaching that sets their goals and communication with their healthcare team. Afterwards, action planning, education, communication, and resource delivery will focus on the patient’s overall health, physical health, nutrition, exercise, and sleep, as well as the patient’s mental and emotional health, financial health, and social health. The coaching program’s next steps will look at putting the pieces together of their coaching, the road ahead for the patient, and how best to continue their care journey.

As a part of the program, the patient’s health advisor will call the patient weekly to discuss their program for approximately 15 minutes. Nudges will be sent to the patient in the form of text messages and emails between the health administrator and patient at a cadence set by the patient’s preference. Supplementary content will be given to the patients on an as-needed basis through the preferred communication channel of the patient.

All patients will use a Fitbit as their wearable and data from the device will be collected and downloaded every 24 hours by Validic to the Pack Health cloud-based server.

“Outcomes from this study….are anticipated to provide insight into diverse [patient reported outcomes], including both validated measures of quality of life and symptom burden, as well as physical activity and qualitative data,” explained principal investigator Elisabet Manasanch, MD, of The university of Texas MD Anderson Cancer Center, and the other investigators in an abstract for the IMS poster. “Results are anticipated to enhance the literature and implications for clinical practice for individuals receiving treatment with isatuximab for RRMM in the real-world setting.”

Isatuximab was approved by the FDA in combination with carfilzomib (Kyprolis) and dexamethasone for adult patients with RRMM who received 1 to 3 previous lines of therapy.² Results of the prospective, randomized, open-label, parallel-group, multi-center, phase 3 IKEMA study (NCT03275285) led to this approval by showing that adding isatuximab to carfilzomib and dexamethasone improved progression-free survival (PFS).³

In the trial, 302 patients were enrolled and 179 were randomly assigned to isatuximab and 123 were assigned to just carfilzomib and dexamethasone. At a median follow up of 20.7 months (interquartile range, 19.4-22.1) adding isatuximab to carfilzomib and dexamethasone had a hazard ratio of 0.53 when comparing PFS between both groups (99% CI, 0.32-0.89; one-sided P = .0007). At 2 years, the estimated PFS rate was 68.9% (95% CI, 60.7%-75.8%) in the isatuximab group compared with 45.7% (95% CI, 35.2%-55.6%) in the control group.

Currently, 5 patients on isatuximab have been enrolled on the trial with a median age of 61.5 years.1 Forty percent are female compared with 60% male, and 80% of the patients so far are White, 20% are Asian, and 40% of patients are Hispanic. Eighty percent of patients are on the combination of isatuximab, pomalidomide (Pomalyst), and dexamethasone compared with 20% on the IKEMA regimen of isatuximab, carfilzomib, and dexamethasone. Comorbidities identified in these 5 patients are diabetes (40%), cardiovascular (80%), autoimmune (20%), and musculoskeletal or respiratory (40%). Forty percent of the patients are on their line of therapy, while 20% each are on their second, fourth, fifth, or later line of therapy.

The trial is currently enrolling after starting on June 17, 2022, and the estimated primary completion date is December 2022. The estimated completion date of the study is currently set for March 2023.

_References

_{1. Manasanch E, Banerjee R, Brassil K, et al. Updated Trial in Progress: Understanding Treatment Experience of Individuals Receiving Isatuximab Using both Patient-Reported Outcomes and Wearable Data. Poster presented at: 19th Annual International Myeloma Society (IMS) Annual Meeting; August 25-27, 2022; Los Angeles, CA. Abstract P-189.}

_{2. FDA approves isatuximab-irfc for multiple myeloma. FDA. April 1, 2021. Accessed August 26, 2022. https://bit.ly/3Atw5r5}

_{3. Moreau P, Dimopoulos MA, Mikhael J, et al; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomized phase 3 trial. Lancet. 2021;397(10292):2361-2371. doi:10.1016/S0140-6736(21)00592-4}