Isatuximab for Multiple Myeloma

Not currently recruiting at 79 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets individuals with multiple myeloma (a type of blood cancer) who have benefited from isatuximab treatment. The main goal is to continue this treatment and ensure its long-term safety. Participants should currently receive isatuximab and find it beneficial. Those who participated in a previous isatuximab study and wish to continue treatment may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that isatuximab is likely to be safe for humans?

Research shows that isatuximab is generally well-tolerated, though some side effects occur. In a study with patients who have multiple myeloma, infections were the most common reason for stopping the treatment, affecting a small number of patients. Other side effects included a drop in white blood cells, pneumonia, reactions during drug administration, and low platelet counts.

While some of these side effects can be serious, they are rare. Healthcare providers closely monitor for any signs of these conditions to manage them quickly. Prospective trial participants should discuss these potential side effects with their doctor to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for multiple myeloma?

Isatuximab is unique because it targets a protein called CD38 on the surface of multiple myeloma cells. This focus on CD38 is important because it helps the immune system recognize and destroy cancer cells more effectively. While traditional treatments for multiple myeloma, like chemotherapy and proteasome inhibitors, generally target the cancer cells in a broader way, isatuximab provides a more targeted approach, potentially leading to fewer side effects and improved outcomes. Researchers are excited about isatuximab because this targeted mechanism could make it a powerful addition to or alternative for existing treatments.

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

Research shows that isatuximab can help treat multiple myeloma. One study found that patients who took isatuximab with other medications had a better chance of living longer without their disease worsening. Specifically, 63% of these patients did not experience disease progression over five years. Another study showed that when used alone, isatuximab led to improvement in 26.3% of patients, indicating significant recovery. In this trial, participants will receive isatuximab either as monotherapy or in a combination regimen. These findings suggest that isatuximab can help manage multiple myeloma and improve patient outcomes. ^{6 7 8 9 10}

Who Is on the Research Team?

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

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

I am using two forms of birth control and am not pregnant or breastfeeding. I will not donate sperm.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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 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]

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, 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 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]

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]

Citations

1. 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) ...

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40257476/

Efficacy and safety of isatuximab monotherapy to treat ... Isatuximab 20 mg/kg monotherapy was effective in the treatment of individuals with RRMM, with an overall response rate (ORR) of 26.3%, a median progression- ...

4. 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.

5. 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 · SARCLISA + VRd ...

6. sarclisahcp.com sarclisahcp.com/ikema-safety-profile

IKEMA Safety - SARCLISA® (isatuximab-irfc) The most frequent adverse reactions requiring permanent discontinuation were infections (2.8%, SARCLISA + Kd; 4.9%, Kd); Dosage interruptions due to an ...

7. sarclisa.com sarclisa.com/

SARCLISA® (isatuximab-irfc) | Official Patient Website Info for patients about the efficacy and safety of SARCLISA (a therapy for multiple myeloma) and how SARCLISA works. See Important Safety & Prescribing Info.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf

SARCLISA® (isatuximab-irfc) injection, for intravenous use The safety of SARCLISA was evaluated in IKEMA, a randomized, open-label clinical trial in patients with previously treated multiple myeloma. Patients received ...

9. sarclisa.com sarclisa.com/possible-side-effects

SARCLISA® (isatuximab-irfc) | Possible Side Effects SARCLISA can cause infections that are severe, life-threatening, or that may lead to death. Your healthcare provider will monitor you for signs and symptoms of ...

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

Isatuximab in Multiple Myeloma: Safety Evaluation AEs commonly observed with isatuximab therapy included neutropenia, pneumonia, infusion-related reactions, thrombocytopenia, acute kidney injury ...