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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand the experience of adults with relapsed or refractory multiple myeloma treated with isatuximab, a monoclonal antibody therapy. Participants will wear a Fitbit and join a digital health coaching program to track their activity and report on their treatment experience and quality of life. The researchers aim to gather diverse data, such as treatment adherence and symptom burden, to better understand how people feel during treatment. This trial suits adults diagnosed with relapsed or refractory multiple myeloma, who are receiving isatuximab, and can use a smartphone. As an unphased trial, this study offers a unique opportunity to contribute to valuable research that could enhance future treatment experiences.

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 prior data suggests that isatuximab is safe for treating multiple myeloma?

Research has shown that isatuximab, a treatment for multiple myeloma, has been studied for its safety. One study found a small 7% increase in the risk of thrombocytopenia, or low platelet count. However, this side effect is considered manageable. The FDA approved isatuximab for treating multiple myeloma in 2020, indicating its safety for patients.

Another study found that a quick, 30-minute infusion of isatuximab was well-tolerated by all patients. No one needed to switch back to the slower infusion method, suggesting the treatment is generally easy to handle.

Overall, while some risks exist, research has found that isatuximab has an acceptable safety profile for patients with multiple myeloma. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Isatuximab is unique because it specifically targets CD38, a protein often found on the surface of multiple myeloma cells. Unlike other treatments that might have broader targets, isatuximab's precise action can lead to more effective targeting of cancer cells with potentially fewer side effects. Researchers are excited about isatuximab as it offers a new mechanism of action that could work even when other therapies, like lenalidomide or bortezomib, have lost their effectiveness. Additionally, the integration of digital health coaching and activity tracking with a Fitbit provides a holistic approach, potentially improving patient outcomes by encouraging healthy lifestyle changes alongside traditional treatment.

What is the effectiveness track record for isatuximab in treating multiple myeloma?

Research has shown that isatuximab effectively treats multiple myeloma, a type of blood cancer. Studies indicate that it can help patients live longer without disease progression. For example, one study found that 63% of patients remained alive without disease progression after five years when isatuximab was combined with other treatments. Another study found that patients benefited from the treatment for over 10 months on average. These findings suggest that isatuximab can be a promising option for those whose multiple myeloma has returned or not responded to previous treatments. Participants in this trial will receive digital health coaching alongside their treatment with isatuximab. ^{2 3 6 7 8}

Who Is on the Research Team?

Melody R Becnel, MD

Principal Investigator

The University of Texas MD Anderson Cancer Center

Rahul Banerjee, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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, 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]

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]

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]

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]

Citations

1. sarclisa.com sarclisa.com/newly-diagnosed-trial-results

Newly Diagnosed Trial Results Trial 3 also measured complete response or better, which means that a patient's multiple myeloma improved with treatment to the point where there are no signs ...

2. myeloma.org myeloma.org/sarclisa-isatuximab-irfc

Sarclisa (isatuximab-irfc) The study included 307 patients from 96 centers across 24 countries. The main efficacy outcome measure was progression-free survival (PFS) using IMWG criteria.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5482100/

A phase 1b study of isatuximab plus lenalidomide and ... Overall median progression-free survival was 8.5 months. Isatuximab exposure increased in a greater than dose-proportional manner; isatuximab and lenalidomide ...

4. sarclisahcp.com sarclisahcp.com/imroz-efficacy

IMROZ Efficacy - SARCLISA® (isatuximab-irfc) Higher 5-year PFS rate with SARCLISA + VRd vs VRd alone: 63% of patients remained alive and progression free at a median follow-up of 60 months. PFS results ...

5. cancernetwork.com cancernetwork.com/view/isatuximab-shows-efficacy-acceptable-safety-across-multiple-myeloma-trials

Isatuximab Shows Efficacy, Acceptable Safety Across ... At a median time to response of 1 month, isatuximab elicited a median duration of response of 10.3 months in patients with multiple myeloma.

6. nature.com nature.com/articles/s41598-024-83014-1

Comprehensive safety evaluation of isatuximab in multiple ... The results demonstrated a 7% increased risk of thrombocytopenia (RR = 1.07, 95% CI: 1.01–1.14, p = 0.0213) (Fig. 3a) in the isatuximab therapy.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2152265025000394

Real-World Safety and Tolerability of Rapid, 30-Minutes ... The rapid 30-minutes intravenous isatuximab was adequately tolerated in all patients. No patient was changed back to the standard administration rate.

8. sarclisa.com sarclisa.com/previously-treated-trial-results

for adults with previously treated multiple myeloma In an earlier analysis, at a median follow-up of 20.7 months, 74% (133 of 179 patients) lived progression free with SARCLISA + Kd vs 59% (73 of 123 patients) ...