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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
Must not have
Female patients who are breast feeding or have a positive serum pregnancy test during the screening period
Refractory to carfilzomib or bortezomib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the date of first dose of study treatment to the date of the first documentation of a confirmed response, assessed up to 2 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently breastfeeding or have tested positive for pregnancy.
Select...
My condition did not improve with carfilzomib or bortezomib treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the date of first dose of study treatment to the date of the first documentation of a confirmed response, 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 the first documentation of a confirmed response, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Response rate of very good partial response (VGPR) or better
Secondary study objectives
Duration of response (DOR)
Incidence of adverse events
Overall response rate (CR + VGPR + partial response [PR]), stable disease or progression
+1 more
Other study objectives
Gene expression profile
Transcribed mutations via RNA-sequencing

Side effects data

From 2021 Phase 4 trial • 45 Patients • NCT03416374
29%
Diarrhoea
24%
White blood cell count decreased
20%
Platelet count decreased
16%
Rash
16%
Neutrophil count decreased
11%
Pneumonia
9%
Constipation
9%
Malaise
9%
Pyrexia
9%
Anaemia
9%
Nasopharyngitis
7%
Decreased appetite
7%
Taste disorder
4%
Acute kidney injury
4%
Influenza
2%
Bile duct stone
2%
Gastroenteritis
2%
Pneumonia bacterial
2%
Bone pain
2%
Febrile neutropenia
2%
Duodenal ulcer
2%
Enterocolitis
2%
Tibia fracture
2%
Interstitial lung disease
2%
Prinzmetal angina
2%
Compression fracture
2%
Spinal compression fracture
2%
Tumour lysis syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
[Overall]; Combination Therapy + Ixazomib Therapy
[VRd]; Bortezomib + Lenalidomide + Dexamethasone Therapy
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
Dexamethasone
2007
Completed Phase 4
~2650
Ixazomib
2017
Completed Phase 4
~3510
Lenalidomide
2005
Completed Phase 3
~2240

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,814 Previous Clinical Trials
8,161,559 Total Patients Enrolled
16 Trials studying Multiple Myeloma
854 Patients Enrolled for Multiple Myeloma
Millennium Pharmaceuticals, Inc.Industry Sponsor
404 Previous Clinical Trials
46,836 Total Patients Enrolled
82 Trials studying Multiple Myeloma
9,990 Patients Enrolled for Multiple Myeloma
Emory UniversityLead Sponsor
1,697 Previous Clinical Trials
2,603,846 Total Patients Enrolled
27 Trials studying Multiple Myeloma
1,873 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 Nov 2025
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