What side effects are associated with this type of intervention?

Common treatments for Plasma Cell Myeloma, such as Isatuximab and Daratumumab (both anti-CD38 monoclonal antibodies), are associated with several side effects. These include a high frequency of grade 3 to 4 neutropenia, increased risk of infections (including upper respiratory tract infections and pneumonia), and infusion-related reactions. Other notable side effects are fatigue, hypertension, diarrhea, anemia, and thrombocytopenia. Additionally, there is a risk of listeriosis with these treatments. Patients may also experience gastrointestinal distress, peripheral neuropathy, and cytopenias with related therapies like bortezomib and lenalidomide.

What prior FDA approvals exist?

Isatuximab, an anti-CD38 monoclonal antibody, has been approved for the treatment of relapsed/refractory multiple myeloma, often in combination with pomalidomide and dexamethasone. Similar treatments include Daratumumab, another anti-CD38 monoclonal antibody, which has been approved in various combinations such as with bortezomib, melphalan, and prednisone for newly diagnosed multiple myeloma, and with lenalidomide and dexamethasone for relapsed/refractory cases. These treatments target CD38 on myeloma cells, enhancing the immune system's ability to combat the disease.

What other types of research exist?

Promising novel alternatives to Isatuximab for Plasma Cell Myeloma patients include Daratumumab (another anti-CD38 monoclonal antibody), Elotuzumab (an anti-SLAMF7 monoclonal antibody), and combination therapies involving Pomalidomide, Bortezomib, and Dexamethasone. These treatments have shown efficacy in clinical trials and are viable options for patients considering treatment in 2024.

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Monoclonal Antibodies

Isatuximab + Pomalidomide + Dexamethasone for Multiple Myeloma (IRAKLIA Trial)

Phase 3

Waitlist Available

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor

Be older than 18 years old

Must not have

Prior therapy with pomalidomide

Known acquired immunodeficiency syndrome (AIDS)-related illness or known human immunodeficiency virus (HIV) disease requiring antiviral treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a combination of three drugs to treat patients with multiple myeloma whose disease has not responded to previous treatments. The drugs include isatuximab, which can be given as an injection or through a vein, along with pomalidomide and dexamethasone. The treatment works by helping the immune system fight cancer and directly attacking cancer cells. Isatuximab is approved for use in combination with pomalidomide and dexamethasone for treating multiple myeloma.

Who is the study for?

This trial is for adults with multiple myeloma who've had at least one prior treatment including lenalidomide and a proteasome inhibitor. They must have measurable levels of certain proteins in their blood or urine, be able to perform daily activities (ECOG ≤2), and agree to use effective birth control. Excluded are those under 18, with severe heart issues, specific other cancers or conditions, or who don't meet safety lab criteria.

What is being tested?

The study compares two ways of giving Isatuximab (either through the skin as SC or into a vein as IV) combined with Pomalidomide and Dexamethasone in patients whose multiple myeloma has returned after treatment. Participants will be randomly assigned to one of these methods and can continue until their disease worsens or they experience unacceptable side effects.

What are the potential side effects?

Possible side effects include reactions at the injection site for SC administration, infusion-related reactions for IV administration, increased risk of infections due to lowered immunity from Dexamethasone and Isatuximab, potential blood clots from Pomalidomide, plus general fatigue and digestive disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have multiple myeloma and have been treated with lenalidomide and a proteasome inhibitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with pomalidomide before.

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I have HIV/AIDS and need antiviral treatment.

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I am under 18 years old.

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I have a serious heart condition.

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I am not using or willing to use effective birth control.

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I have been diagnosed with plasma cell leukemia.

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I have been diagnosed with active AL amyloidosis.

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I cannot tolerate anti-CD38 drugs or it's been less than 9 months since I last used them.

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My physical functioning is severely limited.

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My multiple myeloma did not respond to initial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Observed concentration before dosing (Cthrough) at steady state

Overall response rate (ORR)

Secondary study objectives

Change from baseline in European Organization for Research and Treatment of Cancer core quality of life questionnaire (EORTC QLQ-C30) score

Change from baseline in European Organization for Research and Treatment of Cancer quality of life myeloma module (EORTC QLQ-MY20)

Change from baseline in the European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension (EQ-5D-5L) scores

+21 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Isatuximab Subcutaneous (SC)Experimental Treatment7 Interventions

Isatuximab dose will be administered SC weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days in duration. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.

Group II: Isatuximab Intravenous (IV)Active Control7 Interventions

Isatuximab dose will be administered via IV infusion weekly for 4 weeks during Cycle 1 (Days 1, 8, 15, and 22) and Day 1 and 15 of subsequent cycles. Each cycle will be 28 days. Pomalidomide dose will be taken orally on Day 1 to Day 21 of each cycle at the time that is the most convenient for the participants prior to or after isatuximab administration, preferably at the same time every day. Dexamethasone will be taken orally on Day 1, 8, 15 and 22 (to be repeated every 28 days). Participants may receive other treatments as background treatment and/or rescue medication.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pomalidomide

2011

Completed Phase 2

~1020

Montelukast

2008

Completed Phase 4

~15460

Diphenhydramine

2002

Completed Phase 4

~1170

Methylprednisolone

2015

Completed Phase 4

~2280

Dexamethasone

2007

Completed Phase 4

~2650

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Plasma Cell Myeloma include monoclonal antibodies, proteasome inhibitors, and immunomodulatory drugs. Monoclonal antibodies like Isatuximab target CD38, a protein highly expressed on myeloma cells, leading to cell death through immune-mediated mechanisms. Proteasome inhibitors, such as bortezomib, disrupt protein degradation in myeloma cells, causing apoptosis. Immunomodulatory drugs like lenalidomide enhance the immune system's ability to attack myeloma cells and inhibit their growth. These mechanisms are crucial for patients as they specifically target the malignant cells, improving treatment efficacy and potentially reducing side effects compared to traditional chemotherapy.