What side effects are associated with this type of intervention?

Common treatments for Multiple Myeloma, such as Isatuximab (an anti-CD38 monoclonal antibody) combined with lenalidomide and dexamethasone, often result in side effects like neutropenia, infections (including upper respiratory tract infections and pneumonia), and infusion-related reactions. Other notable adverse events include fatigue, diarrhea, hypertension, and anemia. Severe side effects can include grade 3 or higher neutropenia, pneumonia, and hypertension. Similar treatments, like Daratumumab, also share these side effects, emphasizing the need for careful monitoring and management during therapy.

What prior FDA approvals exist?

Isatuximab is an anti-CD38 monoclonal antibody approved for the treatment of relapsed or refractory multiple myeloma. Similar drugs include Daratumumab, another anti-CD38 monoclonal antibody, which has been approved for use in combination with other agents like lenalidomide and dexamethasone. Other related treatments include Elotuzumab, a monoclonal antibody targeting SLAMF7, which is also used in combination with lenalidomide and dexamethasone. These therapies have shown efficacy in improving progression-free survival and overall response rates in multiple myeloma patients.

What other types of research exist?

Promising novel alternatives to Isatuximab for Multiple Myeloma patients include: 1) Elotuzumab, another monoclonal antibody targeting SLAMF7, which has shown efficacy in combination with lenalidomide and dexamethasone. 2) Daratumumab, an anti-CD38 monoclonal antibody, which has been effective in various combinations, including with bortezomib and dexamethasone. 3) Selinexor, a selective inhibitor of nuclear export, which has shown promise in combination with bortezomib and dexamethasone. 4) Carfilzomib, a proteasome inhibitor, which has demonstrated efficacy in combination with dexamethasone. These alternatives have been evaluated in clinical trials and have shown potential for treating relapsed or refractory Multiple Myeloma.

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Corticosteroid

Isatuximab + Lenalidomide + Dexamethasone for Multiple Myeloma (ITHACA 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

Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 or 2

Capable of giving voluntary written informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to follow-up (up to approximately 7 years)

Awards & highlights

ITHACA Trial Summary

This trial is testing a drug to see if it can help people with a certain type of cancer.

Who is the study for?

This trial is for people diagnosed within the last 5 years with high-risk smoldering multiple myeloma (SMM), which means they have certain levels of M-protein and bone marrow plasma cells but no severe symptoms. They should be able to perform daily activities with ease or with some limitations (ECOG Performance Status 0-2).Check my eligibility

What is being tested?

The study tests if adding Isatuximab to Lenalidomide and Dexamethasone can prolong the time patients live without their disease getting worse, compared to just Lenalidomide and Dexamethasone. It's a Phase 3 trial where one group gets all three drugs, while another gets only two.See study design

What are the potential side effects?

Possible side effects include reactions at the infusion site, increased risk of infections due to low blood cell counts, fatigue, digestive issues like constipation or diarrhea, and potential allergic reactions.

ITHACA Trial Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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I can sign the consent form on my own.

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I was diagnosed with high-risk smoldering multiple myeloma within the last 5 years.

ITHACA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to follow-up (up to approximately 7 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to follow-up (up to approximately 7 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to follow-up (up to approximately 7 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Plasma concentration of isatuximab: Cmax- Safety Run-in Part

Progression-free survival (PFS) Randomized Phase 3

Receptor density/receptor occupancy Safety Run-in Part

+1 more

Secondary outcome measures

Complete response rate - Randomized Phase 3

Duration of response (DOR)-Safety Run-in Part and Randomized Phase 3

EORTC QLQ-MY20 - Randomized Phase 3

+16 more

Side effects data

From 2023 Phase 1 & 2 trial • 351 Patients • NCT01084252

43%

Infusion Related Reaction

29%

Diarrhoea

29%

Cough

29%

Flushing

14%

Wheezing

14%

Skin Disorder

14%

Vomiting

14%

Contusion

14%

Dizziness

14%

Productive Cough

14%

Headache

14%

Stress Cardiomyopathy

14%

Laryngeal Oedema

14%

Parainfluenzae Virus Infection

14%

Pneumonia Streptococcal

14%

Acute Respiratory Failure

14%

Musculoskeletal Chest Pain

14%

Laryngospasm

14%

Cognitive Disorder

14%

Nausea

14%

Stomatitis

14%

Nasopharyngitis

14%

Pyuria

14%

Fatigue

14%

Otitis Media

14%

Upper Respiratory Tract Infection

14%

Procedural Pain

14%

Decreased Appetite

14%

Back Pain

14%

Dysgeusia

14%

Restless Legs Syndrome

14%

Insomnia

14%

Nasal Congestion

14%

Rhinitis Allergic

14%

Pruritus

14%

Rash

14%

Bronchitis

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1: Isatuximab 20mg/kg QW

Phase 1: Isatuximab 1mg/kg Q2W

Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W

Phase 1: Isatuximab 3mg/kg Q2W

Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma)

Phase 1: Isatuximab 20mg/kg Q2W

Phase 2 Stage 2: Isatuximab Alone

Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W

Phase 1: Isatuximab 5mg/kg Q2W

Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W

Phase 2 Stage 2: Isatuximab + Dexamethasone

Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W

Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma)

Phase 1: Isatuximab 10mg/kg QW

ITHACA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Isatuximab, lenalidomide, and dexamethasone (ILd)Experimental Treatment7 Interventions

Participants will receive isatuximab [intravenous (IV) administration] in combination with lenalidomide [per os (PO) administration] and dexamethasone [IV on Day 1 of Cycle 1 for participants receiving isatuximab IV only and PO otherwise for subsequent cycles] for 24 cycles followed by isatuximab monotherapy for 12 cycles for a total duration of 36 cycles. 1 cycle = 28 days. Participants may receive other treatments as pre-medication.

Group II: Lenalidomide and dexamethasone (Ld)Active Control2 Interventions

Lenalidomide [PO administration] in combination with dexamethasone [PO administration] for 24 cycles. 1 cycle = 28 days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetaminophen

2017

Completed Phase 4

~2030

Methylprednisolone or equivalent

2007

Completed Phase 4

~50

Isatuximab SAR650984

2015

Completed Phase 2

~580

Lenalidomide

2005

Completed Phase 2

~1070

Dexamethasone

2007

Completed Phase 4

~2590

0 / 3Eligibility 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 Multiple Myeloma include monoclonal antibodies like Isatuximab, proteasome inhibitors, and immunomodulatory drugs. Isatuximab targets 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 cancer cells, causing apoptosis. Immunomodulatory drugs like lenalidomide enhance the immune system's ability to attack myeloma cells and inhibit their growth. These treatments are crucial as they target specific pathways involved in myeloma cell survival and proliferation, thereby improving patient outcomes and prolonging progression-free survival.