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Monoclonal Antibodies

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

Phase 3

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 4 years

Awards & highlights

IRAKLIA Trial Summary

This trialevaluates two ways of delivering a drug combo to treat multiple myeloma. Participants will receive either a subcutaneous or intravenous infusion plus other drugs until disease progression or AEs.

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.Check my eligibility

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.See study design

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.

IRAKLIA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

IRAKLIA Trial 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

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

Primary outcome measures

Observed concentration before dosing (Cthrough) at steady state

Overall response rate (ORR)

Secondary outcome measures

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

IRAKLIA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Isatuximab Subcutaneous (SC)Experimental Treatment3 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).

Group II: Isatuximab Intravenous (IV)Active Control3 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2590

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,165 Previous Clinical Trials

3,514,768 Total Patients Enrolled

14 Trials studying Plasma Cell Myeloma

3,437 Patients Enrolled for Plasma Cell Myeloma

Clinical Sciences & OperationsStudy DirectorSanofi

863 Previous Clinical Trials

2,019,634 Total Patients Enrolled

12 Trials studying Plasma Cell Myeloma

3,093 Patients Enrolled for Plasma Cell Myeloma

Media Library

Isatuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05405166 — Phase 3

Plasma Cell Myeloma Research Study Groups: Isatuximab Intravenous (IV), Isatuximab Subcutaneous (SC)

Plasma Cell Myeloma Clinical Trial 2023: Isatuximab Highlights & Side Effects. Trial Name: NCT05405166 — Phase 3

Isatuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405166 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What adverse effects could arise from Isatuximab Subcutaneous (SC) administration?

"Isatuximab Subcutaneous (SC) has been evaluated extensively and its safety is considered to be of the highest degree, earning it a score of 3."

Answered by AI

Is there a limit to the number of participants participating in this experiment?

"Affirmative. Data hosted on clinicaltrials.gov demonstrates that this medical investigation, initially posted on June 23rd 2022, is still in need of participants. To date, 534 patients must be accepted at two different sites for the trial to take place."

Answered by AI

Are any fresh participants actively being sought for this research endeavor?

"Affirmative. Information on clinicaltrials.gov indicates that this research project is currently enrolling participants. The trial was published on June 23rd 2022 and underwent its most recent update in December of the same year. A total of 534 patients are required from two different medical sites for data collection purposes."

Answered by AI

What are the foremost aims of this trial?

"The primary outcome of this trial, monitored over a two year period will be the concentration before dosing (Cthrough) at steady state. Secondary outcomes that are being observed include changes from baseline in European Quality of Life Group questionnaire with 5 dimensions and 5 levels per dimension scores, incidence rate of infusion-related reactions as well as duration of response. The EQ-5D-5L is a measure of health status providing an easy to understand generic measure for healthcare utility comprised by self-care mobility pain/discomfort anxiety/depression descriptors and a 20 cm vertical visual analogue scale rating respondent's self rated wellbeing between the best possible health"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM

2022. "SC Versus IV Isatuximab in Combination With Pomalidomide and Dexamethasone in RRMM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405166.