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Iberdomide and Daratumumab for Multiple Myeloma (IBEX Trial)

Phase 2

Recruiting

Led By Jeffery Zonder, M.D.

Research Sponsored by Barbara Ann Karmanos Cancer Institute

Eligibility Criteria Checklist

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

Must have

Patients who have completed Autologous Stem Cell Transplant (ASCT) 90-150 days prior to registration, without any post-ASCT therapy and without post-ASCT disease progression (according to IMWG criteria)

Completed ASCT within 90-150 days prior to registration, without any post-ASCT therapy and without evidence of post-ASCT disease progression (according to IMWG criteria)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

IBEX Trial Summary

This trial is testing if patients with Multiple Myeloma who still have some disease after initial therapy can benefit from continued treatment with Iberdomide and Daratumumab. The trial will assess the

Who is the study for?

This trial is for Multiple Myeloma patients who've had prior therapy with Daratumumab, responded at least partially, completed an Autologous Stem Cell Transplant (ASCT) within the last 90-150 days without progression, and are Minimal Residual Disease positive. They must be physically able to perform daily activities with minimal assistance (ECOG Performance Status ≤2), have adequate bone marrow function and organ function.Check my eligibility

What is being tested?

The trial tests if Iberdomide combined with subcutaneous Daratumumab can effectively maintain remission in Multiple Myeloma patients post-ASCT. It's a phase 2 study where participants receive Iberdomide orally for three weeks of each month and Daratumumab injections weekly initially, then less frequently over up to 26 cycles unless disease progresses.See study design

What are the potential side effects?

Potential side effects include reactions at the injection site from SC Daratumumab, blood cell count changes leading to increased infection risk or bleeding problems, fatigue, liver issues indicated by altered lab results, and kidney impairment as shown by creatinine levels.

IBEX Trial Eligibility Criteria

Inclusion Criteria

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

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I finished my stem cell transplant 3-5 months ago, haven't had treatment since, and my condition hasn't worsened.

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I finished my stem cell transplant 3-5 months ago and haven't had treatment or disease progression since.

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My liver tests are within normal limits, except for Gilbert's syndrome.

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My kidney function is good, with a creatinine clearance rate of at least 30 mL/min.

Select...

I can perform daily activities with minimal assistance.

Select...

I have Multiple Myeloma and responded well to my initial DARA therapy.

Select...

I tested positive for minimal residual disease after my stem cell transplant.

Select...

I have completed at least 3 cycles of DARA therapy and saw some improvement.

IBEX Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Rate of MRD (-) at 12 months

Secondary outcome measures

Frequency of treatment interruptions and dosage adjustments during maintenance

Overall Survival

Patient reported Quality of Life (QoL) per EORTC QLQ-C30

+5 more

IBEX Trial Design

1Treatment groups

Experimental Treatment

Group I: Iberdomide and DaratumumabExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Iberdomide

2021

Completed Phase 1

~60

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen PharmaceuticalsIndustry Sponsor

80 Previous Clinical Trials

205,011 Total Patients Enrolled

11 Trials studying Multiple Myeloma

672 Patients Enrolled for Multiple Myeloma

Barbara Ann Karmanos Cancer InstituteLead Sponsor

163 Previous Clinical Trials

9,196 Total Patients Enrolled

24 Trials studying Multiple Myeloma

1,291 Patients Enrolled for Multiple Myeloma

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,004 Total Patients Enrolled

87 Trials studying Multiple Myeloma

29,860 Patients Enrolled for Multiple Myeloma

Frequently Asked Questions

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

Is this medical study currently open for enrollment?

"As per the available information on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The initial posting of the trial occurred on January 16th, 2024, and it was last updated on December 20th, 2023."

Answered by AI

What is the current number of participants being recruited for this research endeavor?

"Indeed, the information available on clinicaltrials.gov strongly indicates that this research study is currently in the process of actively enrolling eligible participants. The trial was initially posted on January 16th, 2024 and underwent its most recent update on December 20th, 2023. To complete the study objectives, a total of 60 patients will be recruited from a single designated site."

Answered by AI

Have Iberdomide and Daratumumab received official endorsement from the FDA?

"Based on our evaluation, the safety of Iberdomide and Daratumumab is estimated to be at level 2 according to Power's scale. This determination is influenced by the fact that this trial falls under Phase 2, where some data exists supporting safety but none supporting efficacy yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma

Jeffrey Zonder 2024. "Iberdomide and Daratumumab as Maintenance Therapy After an Autologous Stem Cell Transplant for Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06107738.