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Proteasome Inhibitor

Iberdomide + Daratumumab vs. Bortezomib for Multiple Myeloma (EXCALIBER-RRMM Trial)

Phase 3

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

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

Must have

Documented diagnosis of multiple myeloma (MM) and measurable disease

Must have documented disease progression during or after their last anti-myeloma regimen

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

EXCALIBER-RRMM Trial Summary

This trial is testing a new combination of drugs to treat multiple myeloma that has come back or is not responding to treatment.

Who is the study for?

This trial is for people with multiple myeloma who've had 1-2 previous treatments but their cancer has gotten worse. They should be fairly active and able to do light work (ECOG score of 0, 1, or 2). It's not for those with certain other blood disorders, brain involvement by myeloma, or anyone previously treated with Iberdomide.Check my eligibility

What is being tested?

The study compares two drug combos in patients whose multiple myeloma has returned or didn't respond to treatment: one group gets Iberdomide with Dexamethasone and Daratumumab; the other gets Daratumumab, Bortezomib, and Dexamethasone. The goal is to see which works better.See study design

What are the potential side effects?

Possible side effects include fatigue, infections due to a weakened immune system from the drugs used in both treatments. There may also be specific reactions related to each drug like nerve damage from Bortezomib or blood clots from Iberdomide.

EXCALIBER-RRMM Trial Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with multiple myeloma and it can be measured.

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My myeloma has worsened despite my last treatment.

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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 have had 1 or 2 treatments for myeloma before.

EXCALIBER-RRMM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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

Progression-free Survival (PFS)

Secondary outcome measures

Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))

Duration of Response (DoR)

European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)

+12 more

EXCALIBER-RRMM Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3Experimental Treatment3 Interventions

Group II: Daratumumab in combination with Iberdomide and dexamethasone - Dose 2Experimental Treatment3 Interventions

Group III: Daratumumab in combination with Iberdomide and dexamethasone - Dose 1Experimental Treatment3 Interventions

Participants will receive oral iberdomide, subcutaneous daratumumab and oral dexamethasone.

Group IV: Daratumumab in combination with dexamethasone and bortezomibActive Control3 Interventions

Participants will receive subcutaneous daratumumab, bortezomib and oral dexamethasone

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

Daratumumab

2014

Completed Phase 3

~1860

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor

636 Previous Clinical Trials

128,107 Total Patients Enrolled

142 Trials studying Multiple Myeloma

39,999 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,507 Previous Clinical Trials

3,369,133 Total Patients Enrolled

72 Trials studying Multiple Myeloma

24,423 Patients Enrolled for Multiple Myeloma

April Sorrell, MDStudy DirectorCelgene

Media Library

Bortezomib (Proteasome Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04975997 — Phase 3

Multiple Myeloma Research Study Groups: Daratumumab in combination with Iberdomide and dexamethasone - Dose 3, Daratumumab in combination with Iberdomide and dexamethasone - Dose 2, Daratumumab in combination with dexamethasone and bortezomib, Daratumumab in combination with Iberdomide and dexamethasone - Dose 1

Multiple Myeloma Clinical Trial 2023: Bortezomib Highlights & Side Effects. Trial Name: NCT04975997 — Phase 3

Bortezomib (Proteasome Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04975997 — Phase 3

Frequently Asked Questions

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

Is there still room for more participants in this clinical trial?

"Yes, this information is accurate. The last update to the study was on 11/15/2022 and it is still actively recruiting patients that meet the requirements."

Answered by AI

In how many distinct geographical areas is this research being conducted?

"Currently, 37 clinical trial sites are open for recruitment. These locations include Florida Cancer Specialists in Fort Myers, Florida, Center for Cancer And Blood Disorders in Bethesda, Maryland, and Dana Farber Cancer Institute in Boston, Massachusetts."

Answered by AI

How is Daratumumab most often utilized?

"Daratumumab can be used as an effective treatment for ophthalmia, sympathetic, branch retinal vein occlusion, and macular edema."

Answered by AI

Does Daratumumab have a good safety profile?

"Given that this is a Phase 3 trial with evidence of efficacy and multiple rounds of data supporting safety, our team has rated the Daratumumab as having a level 3 safety."

Answered by AI

What other studies has Daratumumab been involved in?

"Daratumumab was first studied in 2002 and, since then, there have been 1,457 completed studies. As of now, there are 710 active studies taking place--a large number of which are located in Fort Myers, Florida."

Answered by AI

How many people have signed up to be a part of this experiment?

"In order to carry out this study, 864 patients who fit the eligibility requirements must enroll. Patients can choose to participate in this trial from different locations, such as Florida Cancer Specialists in Fort Myers, Florida and Center for Cancer And Blood Disorders in Bethesda, Maryland."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

2022. "Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04975997.

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