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Corticosteroid

Ixazomib + Dexamethasone vs. Triple Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Leon Bernal-Mizrachi, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Patients must have confirmed relapsed or refractory MM

Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, or 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of first dose of study treatment to the date of first documented pd or death, assessed up to 2 years

Awards & highlights

Study Summary

This trial is studying how well ixazomib and dexamethasone or ixazomib, dexamethasone, and lenalidomide work in treating patients with multiple myeloma.

Who is the study for?

This trial is for patients with multiple myeloma that has come back or isn't responding to treatment. They must have measurable disease, be in fair health (ECOG 0-2), meet certain blood and biochemical criteria, and not be pregnant or breastfeeding. Participants should have had 1-3 prior treatments but can't join if they've used experimental proteasome inhibitors recently or haven't recovered from previous chemo.Check my eligibility

What is being tested?

The study compares two drug combinations: Ixazomib with Dexamethasone versus Ixazomib, Dexamethasone, and Lenalidomide. It's looking at how well these work based on a gene rearrangement called NFKB2 in the cancer cells. The goal is to see which combination is more effective for treating multiple myeloma.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system stimulation by Lenalidomide, such as blood clots and bone marrow suppression leading to low blood cell counts. Ixazomib may cause gastrointestinal issues like nausea and skin rash, while Dexamethasone can lead to increased appetite, mood changes, and trouble sleeping.

Eligibility Criteria

Inclusion Criteria

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

Select...

My multiple myeloma has returned or is not responding to treatment.

Select...

I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of first dose of study treatment to the date of first documented pd or death, assessed up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of first dose of study treatment to the date of first documented pd or death, assessed up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of first dose of study treatment to the date of first documented pd or death, assessed 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

Response rate of very good partial response (VGPR) or better

Secondary outcome measures

CR, stringent CR, and VGPR rate

Combined CR + VGPR rate

Duration of response (DOR)

+6 more

Other outcome measures

Gene expression profile

Transcribed mutations via RNA-sequencing

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374

26%

Diarrhoea

23%

White blood cell count decreased

21%

Platelet count decreased

15%

Neutrophil count decreased

13%

Pneumonia

Rash

Anaemia

Constipation

Malaise

Pyrexia

Acute kidney injury

Nasopharyngitis

Influenza

Pneumonia bacterial

Tumour lysis syndrome

Febrile neutropenia

Prinzmetal angina

Bile duct stone

Gastroenteritis

Interstitial lung disease

Taste disorder

Enterocolitis

Duodenal ulcer

100%

80%

60%

40%

20%

Study treatment Arm

[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

[Overall]; Combination Therapy + Ixazomib Therapy

[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (ixazomib, dexamethasone, lenalidomide)Experimental Treatment3 Interventions

MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A and lenalidomide PO daily on days 1-21.

Group II: Arm B (ixazomib and dexamethasone)Experimental Treatment2 Interventions

MUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone as in arm A.

Group III: Arm A (ixazomib and dexamethasone)Active Control2 Interventions

UNMUTATED NFKB2 REARRANGEMENT: Patients receive ixazomib and dexamethasone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

2005

Completed Phase 3

~1480

Dexamethasone

2007

Completed Phase 4

~2590

Ixazomib

2017

Completed Phase 4

~3370

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,516 Total Patients Enrolled

16 Trials studying Multiple Myeloma

864 Patients Enrolled for Multiple Myeloma

Millennium Pharmaceuticals, Inc.Industry Sponsor

404 Previous Clinical Trials

46,842 Total Patients Enrolled

82 Trials studying Multiple Myeloma

9,990 Patients Enrolled for Multiple Myeloma

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,501 Total Patients Enrolled

25 Trials studying Multiple Myeloma

1,906 Patients Enrolled for Multiple Myeloma

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT02765854 — Phase 2

Multiple Myeloma Research Study Groups: Arm B (ixazomib and dexamethasone), Arm A (ixazomib and dexamethasone), Arm C (ixazomib, dexamethasone, lenalidomide)

Multiple Myeloma Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT02765854 — Phase 2

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02765854 — Phase 2

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 still available for individuals to join this research project?

"Confirmed, this research endeavour is in its active recruitment phase. The trial was initially published on September 1st 2016 and the record has been updated as recently as January 5th 2022."

Answered by AI

Has the Food and Drug Administration endorsed Ixazomib for commercial use?

"Since this is a Phase 2 trial, meaning there is limited data available on its efficacy but some evidence of safety, our team evaluated the drug's risk level as a 2."

Answered by AI

Have there been any antecedent research experiments using Ixazomib?

"Currently, there are 715 concurrent studies researching Ixazomib, with 168 of those in the advanced Phase 3 phase. Though Joliet, Illinois is the principal hub for these trials, 26000 other facilities are conducting research into this medication."

Answered by AI

What therapeutic objectives is Ixazomib employed to accomplish?

"Ophthalmia, sympathetic ophthalmia, and branch retinal vein occlusion that have failed to respond to a minimum of two systemic chemotherapy treatments can be managed with Ixazomib."

Answered by AI

To what extent is the capacity of this clinical trial being utilized?

"Affirmative. Clinicaltrials.gov details that this clinical trial, which was first advertised on September 1st 2016 and most recently edited on January 5th 2022, is presently recruiting participants across 4 sites with the purpose of finding 90 individuals for inclusion."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement

Leon Bernal-Mizrachi 2016. "Ixazomib and Dexamethasone Versus Ixazomib, Dexamethasone and Lenalidomide, Randomized With NFKB2 Rearrangement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02765854.

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