Isatuximab for Multiple Myeloma

Recruiting at 72 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: Isatuximab

Disqualifiers: Progressive disease, Nonhematologic AEs, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

What is the purpose of this trial?

* This is a multi-center, open-label, Phase 2 treatment extension study in participants with multiple myeloma who are still benefitting from isatuximab based therapy following completion of a Phase 1, 2, or 3 parental study. * This Treatment Extension study has the purpose to provide continued access to isatuximab. Adult participants with multiple myeloma who have enrolled on an isatuximab parental study for which study objectives are completed will be eligible to be enrolled in this Treatment Extension study. * The primary objective of the study is to assess long-term safety of isatuximab as study treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, since this study is an extension of a previous isatuximab study, you may need to continue with isatuximab-based therapy. It's best to discuss your specific situation with the study team or your doctor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the idea that Isatuximab for Multiple Myeloma is an effective drug?

The available research shows that Isatuximab, when combined with other drugs like pomalidomide and dexamethasone or carfilzomib and dexamethasone, helps patients with multiple myeloma by slowing down the progression of the disease. In studies, patients who received Isatuximab with these combinations had longer periods without their disease getting worse compared to those who did not receive Isatuximab. For example, in one study, patients treated with Isatuximab, carfilzomib, and dexamethasone had a median time of about 35.7 months before their disease progressed, compared to 19.2 months for those who did not receive Isatuximab. This suggests that Isatuximab is an effective option for treating multiple myeloma. ^{1 2 3 4 5}

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

Research shows that Isatuximab, when combined with other drugs like pomalidomide and dexamethasone or carfilzomib and dexamethasone, helps patients with multiple myeloma live longer without their disease getting worse. It also improves the depth of tumor response and maintains quality of life, making it an important option for those with relapsed or hard-to-treat multiple myeloma. ^{1 2 3 4 5}

What safety data is available for Isatuximab in treating multiple myeloma?

Isatuximab, also known as Sarclisa or isatuximab-irfc, has been evaluated in several studies for its safety in treating multiple myeloma. In the phase 1/2 ISLANDs study, isatuximab monotherapy was well tolerated in Japanese patients with relapsed/refractory multiple myeloma, with no dose-limiting toxicities reported. The most common adverse events were mild to moderate infusion reactions. In combination therapies, such as with pomalidomide and dexamethasone or carfilzomib and dexamethasone, isatuximab demonstrated a manageable safety profile with no new safety signals. The IKEMA Phase 3 study also confirmed a similar safety profile for isatuximab combined with carfilzomib and dexamethasone. Overall, isatuximab has shown an acceptable safety and tolerability profile in multiple studies. ^{1 2 5 6 7}

Is isatuximab safe for humans?

Isatuximab, also known as Sarclisa, has been generally well tolerated in clinical trials for multiple myeloma, with common side effects including mild to moderate infusion reactions. No serious safety concerns have been consistently reported, indicating it has an acceptable safety profile in humans. ^{1 2 5 6 7}

Is the drug Isatuximab a promising treatment for Multiple Myeloma?

Yes, Isatuximab is a promising drug for treating Multiple Myeloma. It has been shown to significantly extend the time patients live without their disease getting worse when combined with other medications. It also improves the response of the tumor to treatment and maintains the quality of life for patients. It is approved for use in both the USA and the EU, making it an important option for patients whose disease has returned or not responded to previous treatments. ^{1 2 5 8 9}

How is the drug Isatuximab unique in treating multiple myeloma?

Isatuximab is unique because it is a monoclonal antibody that targets the CD38 protein on cancer cells, and when combined with other drugs like pomalidomide and dexamethasone, it significantly prolongs the time patients live without their disease getting worse. It is administered intravenously and is particularly used for patients whose multiple myeloma has returned or not responded to previous treatments. ^{1 2 5 8 9}

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults with multiple myeloma who've benefited from isatuximab in earlier phases of the trial can join. They must be over 18, not pregnant or breastfeeding, use double contraception methods, and have completed previous study objectives. Those still benefiting as judged by their doctor are eligible.

Inclusion Criteria

I am able to understand and sign the consent form.

I am at least 18 years old or the legal age of consent where the study is conducted.

I completed a previous study on isatuximab alone or with other treatments.

Exclusion Criteria

My last treatment for myeloma was not isatuximab-based.

Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.

My cancer got worse during or right after my last study ended.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Extension

Participants continue to receive isatuximab-based therapy until disease progression or other specified conditions

42 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Isatuximab

Trial Overview This Phase 2 extension study tests long-term safety of isatuximab for multiple myeloma patients post-completion of prior studies. It offers continued access to isatuximab either alone or combined with other drugs like dexamethasone and lenalidomide.

Participant Groups

Group I: Isatuximab Experimental Treatment 7 Interventions

Participants will receive isatuximab as monotherapy or in a combination regimen, according to the treatment the participant received on the parental protocol

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?

Sanofi

Lead 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

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]