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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
Age ≥ 18 years of age
Histologically confirmed multiple myeloma according to WHO classification. Pathology report to be sent to BrUOG for confirmation
Must not have
Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort
Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
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.
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.
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 belowSelect...
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 fully active or can carry out light work.
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My liver tests are within normal limits.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken specific strong medications or herbal supplements like Ginkgo biloba or St. John's wort in the last 14 days.
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I do not have an active infection, hepatitis B or C, or HIV.
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I have moderate to severe nerve damage or mild with pain.
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I am not pregnant or breastfeeding.
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My myeloma has spread to my brain or spinal cord.
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I have not had any surgery in the last 14 days.
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I do not have any uncontrolled heart problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2021 Phase 4 trial • 45 Patients • NCT0341637429%
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
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
262 Previous Clinical Trials
68,927 Total Patients Enrolled
The Miriam HospitalOTHER
243 Previous Clinical Trials
37,695 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken specific strong medications or herbal supplements like Ginkgo biloba or St. John's wort in the last 14 days.I have untreated Multiple Myeloma, but may have had emergency steroids or radiation.I have not had radiotherapy in the last 14 days.I do not have an active infection, hepatitis B or C, or HIV.I do not have any stomach or intestine problems that affect my ability to swallow pills.I am 18 years old or older.I haven't had any cancer besides nonmelanoma skin cancer or carcinoma in situ, or if I have, it was treated over 2 years ago with no remaining signs.I have moderate to severe nerve damage or mild with pain.My multiple myeloma diagnosis is confirmed by a pathology report.My kidneys are functioning well enough for treatment.I am a woman who is either not able to have children, practices safe contraception, or is not sexually active.I am a male and agree to use effective contraception or practice true abstinence during and up to 90 days after the study.My tests show measurable signs of my disease, as defined by specific criteria.I am not pregnant or breastfeeding.My blood tests show enough neutrophils and platelets without recent transfusions.I am fully active or can carry out light work.My myeloma has spread to my brain or spinal cord.My liver tests are within normal limits.I have not had any surgery in the last 14 days.I do not have any uncontrolled heart problems.I have not had a serious infection or needed antibiotics in the last week.You are expected to live for at least 6 more months, as confirmed by your doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Ixazomib Regimen
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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