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Corticosteroid

Novel Drug Regimens for Multiple Myeloma

Phase 1 & 2

Waitlist Available

Research Sponsored by iTeos Belgium SA

Eligibility Criteria Checklist

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

Must have

Participants must have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0,1or 2.

Participants must have a documented diagnosis of relapse/refractory Multiple Myeloma and have measurable disease as defined per IMWG criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing a new drug for safety, how well it works, and how it is metabolized in people with relapsed or refractory multiple myeloma.

Who is the study for?

This trial is for people with relapsed or refractory Multiple Myeloma who have tried at least three prior treatments, including IMiD, PI, and Anti-CD-38. They must show measurable disease progression after their last therapy and be in a stable enough condition to participate (ECOG 0-2). Women of childbearing age and men must agree to use contraception.Check my eligibility

What is being tested?

The study is testing EOS884448 alone or combined with iberdomide and dexamethasone for safety, tolerability, effectiveness against the cancer, how it's processed by the body, and its mechanism of action in patients whose multiple myeloma has come back or hasn't responded to treatment.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue from dexamethasone use along with potential blood sugar increases. Gastrointestinal issues may occur due to medication intake affecting absorption.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am able to care for myself and perform daily activities.

Select...

My multiple myeloma has returned or didn't respond to treatment, and it can be measured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Number of participants with any adverse events (AEs) and serious adverse events (SAEs)

Number of participants with dose limiting toxicity (DLT)

Number of participants with overall response (partial or better) as determined by IMWG criteria

+1 more

Secondary outcome measures

Duration of Response (DOR)

Maximum concentration (Cmax) of EOS884448 at each dose level

Percentage of participants with anti-drug antibodies to EOS884448

+2 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Trial Design

3Treatment groups

Experimental Treatment

Group I: C: Participants will receive EOS884448, iberdomide and dexamethasoneExperimental Treatment3 Interventions

EOS884448, iberdomide and dexamethasone will be administered

Group II: B: Participants will receive EOS884448 and iberdomideExperimental Treatment2 Interventions

EOS884448 and iberdomide will be administered

Group III: A: Participants will receive EOS884448Experimental Treatment1 Intervention

EOS884448 will be administered

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iberdomide

2021

Completed Phase 1

~60

Dexamethasone

2007

Completed Phase 4

~2590

EOS884448

2020

Completed Phase 1

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,638 Previous Clinical Trials

4,128,498 Total Patients Enrolled

87 Trials studying Multiple Myeloma

29,904 Patients Enrolled for Multiple Myeloma

iTeos TherapeuticsIndustry Sponsor

7 Previous Clinical Trials

1,381 Total Patients Enrolled

GlaxoSmithKlineIndustry Sponsor

4,750 Previous Clinical Trials

8,067,436 Total Patients Enrolled

47 Trials studying Multiple Myeloma

6,417 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05289492 — Phase 1 & 2

Multiple Myeloma Research Study Groups: C: Participants will receive EOS884448, iberdomide and dexamethasone, A: Participants will receive EOS884448, B: Participants will receive EOS884448 and iberdomide

Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05289492 — Phase 1 & 2

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289492 — Phase 1 & 2

Frequently Asked Questions

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

Is this experiment currently taking on more participants?

"Per clinicaltrials.gov, this medical study is still searching for participants to take part in the trial; it was first made public on May 1st 2022 and received its latest update June 15th of the same year."

Answered by AI

How many individuals are taking part in this experiment?

"Affirmative. According to the details available on clinicaltrials.gov, this medical experiment is actively enrolling patients since its initial posting date of May 1st 2022 and latest update on June 15th 2022. At present, 162 participants are being recruited at one hospital site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma

2022. "Study of Novel Regimens in Relapsed or Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289492.