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Alkylating Agent

Ixazomib + Cyclophosphamide + Dexamethasone for Multiple Myeloma

Phase 2
Waitlist Available
Research Sponsored by John L. Reagan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of Multiple Myeloma that has not been previously treated (although patients that received emergent steroid and/or local radiation therapy will be permitted to enter the study). Details need to be submitted to BrUOG with dates and doses.
Age ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study treatment completion, an average of 2 years
Awards & highlights

Study Summary

This trial will test if ixazomib is more effective and has less side effects than bortezomib.

Who is the study for?
Adults with newly diagnosed multiple myeloma, good liver function, and a life expectancy of at least 6 months can join. They must be able to perform daily activities with ease (ECOG status 0-1) and agree to use effective contraception methods or practice abstinence. Excluded are those with moderate-to-severe peripheral neuropathy, recent surgery or radiotherapy, active infections, known allergies to study drugs, GI issues affecting drug absorption, uncontrolled heart conditions, certain drug interactions within the last two weeks.Check my eligibility
What is being tested?
The trial is testing a combination of Ixazomib (a newer drug potentially better than bortezomib), Cyclophosphamide and Dexamethasone in patients who haven't been treated for multiple myeloma before. The aim is to find out if this regimen is more effective and has fewer side effects like nerve damage compared to current treatments.See study design
What are the potential side effects?
Possible side effects include low blood counts leading to increased infection risk or bleeding problems; nerve damage which might cause pain or numbness; liver issues; allergic reactions; gastrointestinal symptoms like nausea or diarrhea; fatigue; and potential interference with other medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have untreated Multiple Myeloma, but may have had emergency steroids or radiation.
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I am 18 years old or older.
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My multiple myeloma diagnosis is confirmed by a pathology report.
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My kidneys are functioning well enough for treatment.
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I am a woman who is either not able to have children, practices safe contraception, or is not sexually active.
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I am a male and agree to use effective contraception or practice true abstinence during and up to 90 days after the study.
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My tests show measurable signs of my disease, as defined by specific criteria.
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My blood tests show enough neutrophils and platelets without recent transfusions.
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I am fully active or can carry out light work.
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My liver tests are within normal limits.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study treatment completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study treatment completion, an average of 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
Evaluation of the Response Rate of Ixazomib With Metronomic Cyclophosphamide and Dexamethasone for First-line Treatment of Multiple Myeloma.
Secondary outcome measures
Evaluation of the Toxicities Associated With Ixazomib With Metronomic Cyclophosphamide and Dexamethasone.

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%
Compression fracture
17%
Constipation
17%
Malaise
17%
Tibia fracture
17%
Bone pain
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
[KRd]; Carfilzomib + Lenalidomide + Dexamethasone Therapy
[Overall]; Combination Therapy + Ixazomib Therapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Ixazomib RegimenExperimental Treatment3 Interventions
Cycle 1: Ixazomib: 4mg/day 1, 8, 15, Cyclophosphamide: 50 mg/day continuous daily, Dexamethasone: 20 mg/day 1, 8, 15 Cycles 2-6: Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18, Cyclophosphamide: 50 mg/day continuous, daily, Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18 Maintenance: Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Cyclophosphamide
FDA approved
Ixazomib
FDA approved

Find a Location

Who is running the clinical trial?

John L. ReaganLead Sponsor
1 Previous Clinical Trials
11 Total Patients Enrolled
Rhode Island HospitalOTHER
257 Previous Clinical Trials
70,972 Total Patients Enrolled
The Miriam HospitalOTHER
237 Previous Clinical Trials
37,193 Total Patients Enrolled

Media Library

Cyclophosphamide (Alkylating Agent) Clinical Trial Eligibility Overview. Trial Name: NCT02412228 — Phase 2
Multiple Myeloma Research Study Groups: Ixazomib Regimen
Multiple Myeloma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT02412228 — Phase 2
Cyclophosphamide (Alkylating Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02412228 — Phase 2

Frequently Asked Questions

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

Are participants being enrolled in this clinical trial at the current time?

"This study is no longer recruiting patients. Although it was last updated on 7/21/2022, the trial was originally posted on 8/1/2015. There are presently 827 trials actively enrolling patients with multiple myeloma and 1349 trials for Ixazomib actively enrolling participants if you are seeking other studies to participate in."

Answered by AI

What conditions does Ixazomib typically help ameliorate?

"Ixazomib is used to treat synovitis, but it has also been found helpful in managing ophthalmia, sympathetic nerve disorders, and various types of cancer including those effecting the lungs and retina."

Answered by AI

Are there any other scientific papers that mention Ixazomib?

"There are 1349 clinical trials currently underway for the use of Ixazomib. 278 of these studies have reached Phase 3 testing. The majority of these trials originate from Philadelphia, Pennsylvania; however, there are 42384 total locations running similar tests."

Answered by AI

Could you please give an overview of Ixazomib's safety profile?

"While there is some data suggesting Ixazomib's safety, it is still in Phase 2 of clinical trials and has not been proven effective yet. Consequently, our team at Power only rates its safety as a 2."

Answered by AI

How many patients are included in the scope of this experiment?

"Though this particular clinical trial is not seeking new participants at the moment, there are plenty of other research studies that might be a better fit. There are 827 trials actively recruiting patients with multiple myeloma and 1349 Ixazomib trials enrolling patients right now."

Answered by AI
~1 spots leftby Mar 2025