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Proteasome Inhibitor
Ixazomib for Multiple Myeloma
Phase 2
Waitlist Available
Led By Shaji Kumar
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recovered (i.e., < grade 1 toxicity) from the reversible effects of prior antineoplastic therapy
Patients with relapsed multiple myeloma who have already received one or more standard treatment regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2.5 years
Awards & highlights
Study Summary
This trial study looks at the effects of ixazomib citrate on patients with multiple myeloma who have had a relapse, but are still responsive to bortezomib. Ixazomib citrate may prevent cancer cell growth by blocking some of the enzymes necessary for cell growth.
Who is the study for?
This trial is for patients with relapsed multiple myeloma who are not resistant to bortezomib. They should have recovered from previous treatments, have adequate organ function, and no severe concurrent illnesses. Those with certain infections or a recent history of other cancers (except nonmelanoma skin cancer) are excluded.Check my eligibility
What is being tested?
The study tests ixazomib citrate's effectiveness in treating relapsed multiple myeloma when it's not refractory to bortezomib. It includes dexamethasone, cyclophosphamide, daratumumab, and lab biomarker analysis to see if the drug can halt cancer cell growth by blocking key enzymes.See study design
What are the potential side effects?
Potential side effects may include fatigue, digestive issues like diarrhea or nausea, blood disorders such as low platelet counts or anemia, nerve damage that could cause pain or numbness (peripheral neuropathy), and increased risk of infection due to immune system suppression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have recovered from side effects of my previous cancer treatment.
Select...
I have multiple myeloma and have undergone at least one standard treatment.
Select...
I can take care of myself and perform daily activities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of confirmed responses with ixazomib citrate alone (Arm A [closed]), ixazomib citrate with dexamethasone (Arms B + C), or with dexamethasone and cyclophosphamide (Arm D), or with dexamethasone, cyclophosphamide, daratumumab (Arm E)
Secondary outcome measures
Dexamethasone
Event-free survival
Incidence of adverse events
+1 moreSide effects data
From 2021 Phase 2 trial • 8 Patients • NCT03202628100%
Fatigue
100%
Neutrophil count decreased
100%
White blood cell decreased
88%
Platelet count decreased
75%
Diarrhea
75%
Lymphocyte count decreased
63%
Constipation
63%
Peripheral sensory neuropathy
50%
Nausea
50%
Creatinine increased
25%
Hyperglycemia
13%
Urinary tract infection
13%
Wrist fracture
13%
Cardiac disorders - Other, specify
13%
Vomiting
13%
Anorexia
13%
Insomnia
13%
Hypoxia
13%
Resp, thoracic, mediastinal - Oth spec
13%
Hypoglycemia
13%
Tremor
13%
Anemia
13%
Blood and lymph sys disorders - Oth Spec
13%
Febrile neutropenia
13%
Fever
13%
Alkaline phosphatase increased
13%
Pneumonitis
13%
Rash maculo-papular
13%
Thromboembolic event
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT)
Trial Design
5Treatment groups
Experimental Treatment
Group I: Arm E (ixazomib citrate, cyclophosphamide, daratumumab)Experimental Treatment5 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm D (ixazomib citrate, dexamethasone, and cyclophosphamide)Experimental Treatment4 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm C (higher-dose ixazomib citrate and dexamethasone)Experimental Treatment3 Interventions
Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group IV: Arm B (ixazomib citrate and dexamethasone)Experimental Treatment3 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group V: Arm A (ixazomib citrate and dexamethasone, closed to accrual)Experimental Treatment3 Interventions
Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Daratumumab
2014
Completed Phase 3
~1860
Cyclophosphamide
1995
Completed Phase 3
~3780
Ixazomib Citrate
2012
Completed Phase 2
~200
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,205 Previous Clinical Trials
3,766,676 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,603 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,045 Total Patients Enrolled
578 Trials studying Multiple Myeloma
188,622 Patients Enrolled for Multiple Myeloma
Shaji KumarPrincipal InvestigatorMayo Clinic
15 Previous Clinical Trials
1,586 Total Patients Enrolled
15 Trials studying Multiple Myeloma
1,586 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have hepatitis B or active hepatitis C infection.I am HIV positive.This criterion refers to a list of specific conditions or factors that will be mentioned in the following text.I have recovered from side effects of my previous cancer treatment.My condition did not improve after treatment with a proteasome inhibitor and daratumumab.I have COPD with less than half the normal lung function.I have had moderate to severe asthma in the last 2 years or currently have uncontrolled asthma.My kidney function, measured by creatinine clearance, is adequate.I haven't had any cancer besides nonmelanoma skin cancer or carcinoma in situ, or if I have, it was more than 2 years ago and fully treated.I am not on any other experimental treatments but can take bisphosphonates.I do not have uncontrolled heart problems or recent heart attacks.My multiple myeloma can be measured by medical tests.Women who can have babies need to have a negative pregnancy test within 7 days before joining the trial.I have not been treated with proteasome inhibitors, or I've had less than 6 cycles without resistance.I have mild to no diarrhea without taking medication for it.I have severe nerve damage in my hands or feet, or moderate with pain.I have tested negative for hepatitis B or only have antibodies due to vaccination.Your white blood cell count is at least 1000/mL.Your platelet count is higher than 75,000 per milliliter and you have not received a platelet transfusion in the past 14 days.Your total bilirubin level should be no more than 1.5 times the upper limit of normal.Your liver enzymes (ALT and AST) are not more than three times the normal level.I have multiple myeloma and have undergone at least one standard treatment.I can take care of myself and perform daily activities.I haven't taken certain strong medications or herbal supplements like St. John's wort in the last 14 days.I have recently undergone chemotherapy.I do not have any major health issues that would prevent me from joining the trial.I have not had major surgery in the last 14 days.I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.Your hemoglobin level is at least 8.0 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Arm C (higher-dose ixazomib citrate and dexamethasone)
- Group 2: Arm B (ixazomib citrate and dexamethasone)
- Group 3: Arm A (ixazomib citrate and dexamethasone, closed to accrual)
- Group 4: Arm E (ixazomib citrate, cyclophosphamide, daratumumab)
- Group 5: Arm D (ixazomib citrate, dexamethasone, and cyclophosphamide)
Awards:
This trial has 1 awards, including:- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to join the experiment at this time?
"This trial is no longer accepting candidate applications. It was initially posted on January 31st, 2012 and last updated on October 25th, 2022. If you're in search of other studies, 807 trials are actively looking for patients with refractory plasma cell myeloma while 1345 clinical trials are recruiting participants to participate in Ixazomib Citrate research."
Answered by AI
What potential adverse effects could Ixazomib Citrate have on those consuming it?
"Our experts at Power graded Ixazomib Citrate a 2 due to the preliminary safety data collected in its Phase 2 trial, with no evidence of efficacy yet reported."
Answered by AI
What benefits are anticipated from the results of this experiment?
"This clinical trial is expected to last up to 2.5 years and its primary outcome will be the proportion of confirmed responses with ixazomib citrate alone, ixazomib citrate plus dexamethasone, or ixazomib citrate plus dexamethasone and cyclophosphamide. Secondary outcomes that are being monitored include a confirmed response rate with single agent ixazomib citrate or ixazomib citrate combined with dexmethasone, incidence of adverse events according to NCI CTCAE version 3.0 standards, as well as event-free"
Answered by AI
Are there additional investigations involving Ixazomib Citrate?
"At present, 1,345 different trials are in operation analysing the efficacy of Ixazomib Citrate. Of those tests 275 have reached Phase 3 and studies for this drug are being carried out across 43226 sites with a majority situated within Philadelphia, Pennsylvania."
Answered by AI
What is the maximum capacity of participants for this medical experiment?
"This research project is no longer actively seeking participants. This study was first published on the 31st of January 2012 and underwent its last update on October 25th 2022. If you are searching for alternative trials, 807 clinical studies recruiting refractory plasma cell myeloma patients remain open, as well as 1345 experiments that involve Ixazomib Citrate."
Answered by AI
What conditions is Ixazomib Citrate traditionally prescribed to treat?
"Ixazomib Citrate is frequently prescribed for synovitis and can also be beneficial in managing ophthalmia, sympathetic disorders, lung cancers and branch retinal vein occlusion."
Answered by AI
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