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Corticosteroid

Mezigdomide + Ixazomib + Dexamethasone for Multiple Myeloma

Phase 1 & 2
Recruiting
Led By Kathleen A Dorritie, MD
Research Sponsored by Kathleen Dorritie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status < 2
Patients must have a confirmed diagnosis of multiple myeloma and have received 1-3 prior lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing new treatments for multiple myeloma, an incurable blood cancer, to improve the median life expectancy to 10 years. It is monitoring toxicity and side effects closely to maximize patient safety.

Who is the study for?
This trial is for adults with multiple myeloma who've had 1-3 prior treatments and have been exposed to specific anti-myeloma drugs. They must be relatively fit (ECOG <2), not pregnant, willing to follow pregnancy prevention measures, and without certain other health conditions or recent participation in another clinical trial.Check my eligibility
What is being tested?
The study tests Mezigdomide combined with Ixazomib and Dexamethasone in patients with relapsed/refractory multiple myeloma. Dosages are adjusted based on age, previous side effects, or comorbidities. The trial includes close monitoring for safety.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system, blood disorders, increased risk of infections due to lowered immunity from Dexamethasone, possible liver enzyme changes due to Ixazomib, and gastrointestinal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most of my daily activities without help.
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I have multiple myeloma and have been treated 1-3 times before.
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I have measurable signs of multiple myeloma.
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I have been treated with a proteasome inhibitor, IMiD, and anti-CD38 antibody.
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I can get ixazomib for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
Phase l: Recommended Phase II Dose (RP2D)
Phase ll: Overall Response Rate (ORR)
Secondary outcome measures
Depth of Response
Duration of Response (DOR)
Incidence and severity of Adverse Events
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase ll (RP2D): Mezigdomide + Ixazomib + DexamethasoneExperimental Treatment3 Interventions
Mezigdomide: RP2D daily on days 1-21 of a 28-day schedule Ixazomib: RP2D PO weekly on days 1, 8 and 15 of a 28-day schedule Dexamethasone: RP2D on days 1, 8, 15 and 22
Group II: Phase l: Mezigdomide + Ixazomib + DexamethasoneExperimental Treatment3 Interventions
Dose level -2: Mezigdomide: 0.3 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 2.3 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level -1: Mezigdomide: 0.6 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 2.3 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level 0 (Starting dose): Mezigdomide: 0.6 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 3.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level +1: Mezigdomide: 1.0 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 3.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22 Dose level +2: Mezigdomide: 1.0 mg daily on days 1-21 of a 28-day schedule; Ixazomib: 4.0 mg PO weekly on days 1, 8 and 15 of a 28-day schedule; Dexamethasone: 40 or 20 mg on days 1, 8, 15 and 22
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Mezigdomide
2023
Completed Phase 1
~40
Ixazomib
2017
Completed Phase 4
~3370

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Who is running the clinical trial?

Kathleen DorritieLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,639 Previous Clinical Trials
4,128,966 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,886 Patients Enrolled for Multiple Myeloma
Kathleen A Dorritie, MDPrincipal InvestigatorUPMC Hillman Cancer Center

Frequently Asked Questions

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

Are there any openings available for participants in this research study?

"As evidenced by clinicaltrials.gov, this trial is not currently enrolling patients at the moment despite being posted on October 1st 2023 and updated recently on September 15th 2023. Nevertheless, there are 812 other trials that have contracted participants already."

Answered by AI

In what ways is this research endeavor being designed to benefit the public?

"Bristol-Myers Squibb, the primary sponsor of this trial, has stipulated that the main objective they will be evaluating over a 17 month period is Overall Response Rate (ORR). Additionally, investigators are tasked with assessing secondary outcomes such as Depth of Response (given by IMWG Uniform Response Criteria), Duration of Reponse, and Progression-free Survival."

Answered by AI
~23 spots leftby Oct 2026