← Back to Search

Corticosteroid

Mezigdomide + Ixazomib + Dexamethasone for Multiple Myeloma

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

<p>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.</p>

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

<p>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.</p>

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

Select...

I can do most of my daily activities without help.

Select...

I have multiple myeloma and have been treated 1-3 times before.

Select...

I have measurable signs of multiple myeloma.

Select...

I have been treated with a proteasome inhibitor, IMiD, and anti-CD38 antibody.

Select...

I can get ixazomib for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

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

Mezigdomide

2023

Completed Phase 1

~40

Dexamethasone

2007

Completed Phase 4

~2590

Ixazomib

2017

Completed Phase 4

~3370

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kathleen DorritieLead Sponsor

1 Previous Clinical Trials

1 Total Patients Enrolled

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,030 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

Recent research and studies

clinicaltrials.govStudy

Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma

Kathleen Dorritie 2023. "Mezigdomide Plus Ixazomib and Dexamethasone for Relapsed and Refractory Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06050512.