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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 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
67%
Rash
50%
Diarrhoea
50%
Decreased appetite
33%
Nasopharyngitis
33%
Taste disorder
33%
White blood cell count decreased
17%
Bone pain
17%
Compression fracture
17%
Constipation
17%
Malaise
17%
Tibia fracture
17%
Neutrophil count decreased
17%
Anaemia
17%
Pyrexia
17%
Platelet count decreased
17%
Spinal compression fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy
[KRd]; Carfilzomib + 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 2
~1070
Dexamethasone
2007
Completed Phase 4
~2590
Ixazomib
2017
Completed Phase 4
~3370

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,212 Total Patients Enrolled
16 Trials studying Multiple Myeloma
865 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
1,646 Previous Clinical Trials
2,564,528 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,904 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
~8 spots leftby Jun 2025
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