Isatuximab for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Jennifer Loftis, DNP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pack Health

Must be taking: Isatuximab-irfc

Disqualifiers: Terminally ill, Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This descriptive study aims to evaluate the experience of adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc through collection of quantitative, qualitative and wearable data. Fifty adults with relapsed or refractory multiple myeloma receiving standard of care isatuximab-irfc will be enrolled across 2 sites, The University of California San Francisco and The University of Texas MD Anderson Cancer Center. Consented participants will be enrolled in a 3-month digital health coaching program through which electronic patient reported outcomes and wearable activity data will be collected. Outcomes include treatment experience, quality of life, financial toxicity, treatment adherence, symptom burden and health self-efficacy. These will be captured by patient reported outcome measures including the Patient's Qualitative Assessment of Treatment- Real World (PQAT-RW), Patient Global Impression of Change/Severity (PGIC/S), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30), Quality of Life Questionnaire Multiple Myeloma (QLQ-MY20), and the European QoL-5 Dimensions (EQ5D), Cancer Behavior Inventory-Brief Form (CBI-B), Center for Adherence Support Evaluation (CASE) Medication Adherence Index, Comprehensive Score for Financial Toxicity (COST) Instrument. Clinical data, including treatment history, healthcare utilization, and co-morbidities, as well as demographic data will be collected via the electronic health record from each clinical site. This data will be complemented by qualitative data from a selected cohort of study participants with a focus on treatment experience ranging from infusion burden, toxicity management, to overall quality of life. Evaluation of this data in combination will be used to better understand the treatment experience of individuals on standard of care isatuximab-irfc specifically, and with relapsed or refractory multiple myeloma generally, contributing to an existing gap in the literature regarding patient reported outcomes from diverse data sources. Outcomes will be analyzed with attention to the relationship between social determinants of health, including race, ethnicity, and geographic location, and treatment experience as reflected in both the qualitative and quantitative data.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that concurrent therapy with other agents, like pomalidomide, is allowed.

What data supports the effectiveness of the drug Isatuximab for treating multiple myeloma?

Isatuximab, when combined with other drugs like pomalidomide and dexamethasone or carfilzomib and dexamethasone, has been shown to help patients with multiple myeloma live longer without their disease getting worse. Studies found that these combinations improved the depth of tumor response and maintained quality of life, making them important options for patients whose cancer has returned or not responded to previous treatments. ^{1 2 3 4 5}

Is isatuximab safe for humans?

Isatuximab, also known as Sarclisa, has been studied in multiple clinical trials for multiple myeloma and has shown an acceptable safety profile. Common side effects include infusion reactions, which are generally mild and occur during the first infusion. Overall, it is considered well tolerated in patients with relapsed or refractory multiple myeloma. ^{1 2 5 6 7}

How is the drug Isatuximab unique in treating multiple myeloma?

Isatuximab is unique because it is an anti-CD38 monoclonal antibody that targets a specific protein on the surface of cancer cells, and it is used in combination with other drugs like pomalidomide and dexamethasone to treat relapsed or refractory multiple myeloma. This combination has been shown to significantly prolong the time patients live without their disease getting worse, compared to other treatments. ^{1 2 5 8 9}

Research Team

Melody R Becnel, MD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Rahul Banerjee, MD

Principal Investigator

University of Washington

Eligibility Criteria

Adults with relapsed or refractory multiple myeloma who can use a smartphone, are willing to wear a Fitbit, and have an ECOG performance status of 2 or less. They must be receiving isatuximab-irfc as standard care but cannot be terminally ill or on comfort measures only.

Inclusion Criteria

Age 18 or older

Access to and willingness to use a smartphone or other device through which they can send and receive text messages, emails and/or access a mobile application

Willingness to wear and have data collected by a Fitbit

Exclusion Criteria

Individuals for whom there is documentation of inability to provide consent in the medical record

You have been identified by your doctor as having 6 months or less to live, or you are receiving only supportive care without curative treatment.

You are currently receiving isatuximab-irfc through subcutaneous injection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Digital Health Coaching Program

Participants are enrolled in a 3-month digital health coaching program, during which electronic patient reported outcomes and wearable activity data are collected.

12 weeks

Continuous digital engagement

Qualitative Interview

A one-time interview is conducted to learn more about the experience of individuals related to their diagnosis, treatment, symptoms, side effects, and overall care experience.

1 week

1 visit (virtual or in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with attention to changes in quality of life and treatment experience.

4 weeks

Treatment Details

Interventions

• Isatuximab

Trial Overview The study evaluates the treatment experience of patients using isatuximab-irfc through patient-reported outcomes and wearable data. It involves a digital health coaching program over three months at two research sites.

Participant Groups

Group I: 1. Single Arm Cohort Receiving Digital Health Coaching Experimental Treatment 2 Interventions

All study participants will be enrolled in a 3-month digital health coaching program. They will also receive a Fitbit device to be worn daily for the capture of physical activity data. Participants have the option to participate in a one time interview about their treatment experience.

Isatuximab is already approved in European Union, United States for the following indications:

Approved in European Union as Sarclisa for:

• Multiple myeloma

Approved in United States as Sarclisa for:

• Multiple myeloma in combination with pomalidomide and dexamethasone for adults who have received at least two prior therapies including lenalidomide and a proteasome inhibitor
• Multiple myeloma in combination with carfilzomib and dexamethasone for adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
• Newly diagnosed multiple myeloma in combination with bortezomib, lenalidomide, and dexamethasone for adults who are not eligible for autologous stem cell transplant

Who Is Running the Clinical Trial?

Pack Health

Lead Sponsor

Trials

6

Recruited

1,100+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Findings from Research

Isatuximab, an anti-CD38 monoclonal antibody, significantly improves progression-free survival and tumor response when combined with pomalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma, based on phase III studies.

The combination therapies involving isatuximab were generally well tolerated, maintaining health-related quality of life and showing a manageable safety profile without new safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isatuximab: A Review of Its Use in Multiple Myeloma. Frampton, JE.[2022]

Isatuximab is an IgG1 monoclonal antibody that targets CD38 on cancer cells and has been approved in the USA for treating multiple myeloma in patients who have undergone at least two prior therapies.

The approval of isatuximab, in combination with pomalidomide and dexamethasone, marks a significant advancement in treatment options for adult patients with relapsed and refractory multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isatuximab: First Approval. Dhillon, S.[2021]

The combination of isatuximab and carfilzomib was well tolerated in 33 patients with relapsed and refractory multiple myeloma, showing no unexpected toxicity and an overall response rate of 70%.

With a median follow-up of 26.7 months, the treatment resulted in a median progression-free survival of 10.1 months, indicating its effectiveness even in heavily pretreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 1b trial of isatuximab, an anti-CD38 monoclonal antibody, in combination with carfilzomib as treatment of relapsed/refractory multiple myeloma. Martin, TG., Shah, N., Richter, J., et al.[2021]

Isatuximab, a humanized IgG1 monoclonal antibody targeting CD38, was approved by the FDA in March 2020, adding a new option for treating multiple myeloma.

The use of monoclonal antibodies like isatuximab, along with other therapies such as immunomodulatory drugs and proteasome inhibitors, allows for more complex treatment regimens (3 to 4 drugs) while maintaining acceptable safety profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic potential of isatuximab in the treatment of multiple myeloma: Evidence to date. Richter, J., Sanchez, L., Thibaud, S.[2021]

In a Phase 3 trial with 302 patients suffering from relapsed/refractory multiple myeloma, the combination of isatuximab with carfilzomib-dexamethasone significantly prolonged progression-free survival (PFS) to a median of 35.7 months compared to 19.2 months for carfilzomib-dexamethasone alone.

The addition of isatuximab also resulted in higher rates of complete response (44.1% vs 28.5%) and minimal residual disease negativity (33.5% vs 15.4%), indicating improved efficacy without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. Martin, T., Dimopoulos, MA., Mikhael, J., et al.[2023]

Isatuximab monotherapy was found to be well tolerated and effective in Japanese patients with relapsed/refractory multiple myeloma, with an overall response rate of 36.4% and a clinical benefit rate of 54.5%.

The study identified a recommended dose of 20 mg/kg administered weekly and bi-weekly, with a median progression-free survival of 5.6 months, indicating promising antitumor activity and an acceptable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-CD38 antibody isatuximab monotherapy for Japanese individuals with relapsed/refractory multiple myeloma: An update of the phase 1/2 ISLANDs study. Sunami, K., Fuchida, SI., Suzuki, K., et al.[2023]

Isatuximab, an anti-CD38 monoclonal antibody, was found to be well tolerated and effective in treating heavily pretreated relapsed/refractory multiple myeloma, with an overall response rate of 36.4% in a phase 2 trial involving 28 patients.

The most common side effects were mild infusion reactions occurring in 42.9% of patients, indicating a manageable safety profile, while the median progression-free survival was 4.7 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isatuximab monotherapy in relapsed/refractory multiple myeloma: A Japanese, multicenter, phase 1/2, safety and efficacy study. Sunami, K., Suzuki, K., Ri, M., et al.[2020]

Isatuximab, a monoclonal antibody targeting CD38, was shown to significantly improve progression-free survival in adult patients with relapsed and refractory multiple myeloma when used in combination with pomalidomide and dexamethasone, compared to pomalidomide plus dexamethasone alone.

While treatment with isatuximab was associated with a higher incidence of treatment-related adverse events, including serious complications, the overall safety profile was deemed acceptable, leading to a positive benefit-risk ratio for its use in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma. Delgado, J., Zienowicz, M., van Hennik, PB., et al.[2021]

In the Phase 3 IKEMA study, the combination of isatuximab (Isa) with carfilzomib (K) and dexamethasone (d) significantly improved progression-free survival (PFS) in East Asian patients with relapsed multiple myeloma compared to the carfilzomib and dexamethasone (Kd) regimen.

The Isa-Kd combination also showed higher rates of very good partial response (≥VGPR), complete response (CR), and minimal residual disease (MRD) negativity, while maintaining a safety profile consistent with the overall IKEMA population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis. Kawano, Y., Kim, K., Min, CK., et al.[2023]

References

1. France pubmed.ncbi.nlm.nih.gov

Isatuximab: A Review of Its Use in Multiple Myeloma. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Isatuximab: First Approval. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Phase 1b trial of isatuximab, an anti-CD38 monoclonal antibody, in combination with carfilzomib as treatment of relapsed/refractory multiple myeloma. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Therapeutic potential of isatuximab in the treatment of multiple myeloma: Evidence to date. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Anti-CD38 antibody isatuximab monotherapy for Japanese individuals with relapsed/refractory multiple myeloma: An update of the phase 1/2 ISLANDs study. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Isatuximab monotherapy in relapsed/refractory multiple myeloma: A Japanese, multicenter, phase 1/2, safety and efficacy study. [2020]

8. England pubmed.ncbi.nlm.nih.gov

EMA Review of Isatuximab in Combination with Pomalidomide and Dexamethasone for the Treatment of Adult Patients with Relapsed and Refractory Multiple Myeloma. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Isatuximab Plus Carfilzomib and Dexamethasone in East Asian Patients With Relapsed Multiple Myeloma: Updated IKEMA Subgroup Analysis. [2023]