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Ixazomib + Cyclophosphamide + Dexamethasone for Multiple Myeloma
Study Summary
This trial is testing cyclophosphamide given with ixazomib citrate and dexamethasone to see what effects, good and bad, it has in treating patients with previously untreated multiple myeloma or light chain amyloidosis.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a high level of a specific type of protein in your blood.I am not on any experimental treatments, but I may be taking bisphosphonates for bone health.You have a known hepatitis B infection or an active hepatitis C infection.I have amyloidosis affecting my organs and need treatment.Your liver enzyme levels (ALT and AST) are not more than three times the normal limit.I have severe nerve pain or numbness in my hands or feet.Your blood tests show high levels of a specific protein and an irregular ratio of two types of proteins.I have not had major surgery in the last 14 days.COHORT B ONLY: Your alkaline phosphatase levels must be less than or equal to 750 U/L.Women who can have babies need to have a negative pregnancy test within 7 days before joining the study.I am a male and agree to follow the birth control requirements.I haven't taken any strong medication that affects liver enzymes in the last 2 weeks.For group B only: Your NT-ProBNP level needs to be less than 7500 ng/dL.You have more than 200 milligrams of a specific protein in your urine over a 24-hour period.I have been diagnosed with MGUS or smoldering myeloma.I agree to practice true abstinence as a form of contraception.I agree to follow one of the birth control methods if I can have children.I have mild to no diarrhea without taking medication for it.I have multiple myeloma and am interested in Phase I, Cohort A.I do not have severe heart problems or recent heart attacks.I have a stomach or intestine condition that affects how I absorb pills or makes it hard for me to swallow.I had treatment for solitary plasmacytoma over 14 days ago. I may have used specific allowed medications.My kidneys are functioning well enough, with a creatinine clearance of at least 30 mL/min.I do not have any major health issues that would prevent me from joining the trial.I am HIV positive.Only for Cohort B: Your blood test shows high levels of a substance called immunoglobulin free light chain and an abnormal ratio of different types of this substance.Your hemoglobin level is at least 8.0 grams per deciliter.Your platelet count is at least 75,000 per cubic millimeter.You have a high enough count of a type of white blood cell called neutrophils.I had radiotherapy less than 2 weeks ago, or 1 week if the treated area was small.I have not received any treatment for my condition.I haven't had any cancer besides nonmelanoma skin cancer or in situ carcinoma, or if I did, it was more than 2 years ago and fully treated.I am of childbearing age and do not plan to use birth control.I am currently breastfeeding.I am able to care for myself and perform daily activities.My multiple myeloma can be measured by medical tests.I have received chemotherapy or steroids for multiple myeloma, but steroids for non-cancer conditions are okay.Your total bilirubin level is less than or equal to 1.5 times the normal limit.
- Group 1: Treatment (ixazomib citrate, cyclophosphamide, dexamethasone)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is there capacity for additional participants in this clinical experiment?
"Unfortunately, this clinical trial is no longer open for new enrollees. The protocol was published on August 20th 2013 and had its last amendment submitted on 25th of August 2022. Fortunately, there are currently 905 studies recruiting participants with amyloidosis and 1296 trials looking to recruit candidates for Pharmacological Study."
What key objectives is this clinical experiment striving to achieve?
"The main target of this nearly year-long trial is to establish the Maximum Tolerable Dose (MTD) of Cyclophosphamide. To evaluate treatment efficacy, secondary objectives including Progression Free Survival rate, overall Survival Time and Number of Patients with Grade 3 or Higher Adverse Events will be measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. These grades indicate a severe but non-life threatening medical issue that require hospitalization or prolongation of it; disabling symptoms; and limiting self care ability as per daily activities definition."
Could you provide an overview of the existing research on Pharmacological Study?
"Currently, there are 1,296 pharmacological studies underway worldwide with 270 of them in their final phase. Most notably, Philadelphia is running a significant amount of trials for this medical intervention with 41,819 total locations conducting research on the subject matter."
How many participants have so far enrolled in this experiment?
"At present, this trial is not accepting any more patients. It was first published on August 20th 2013 and the last update occurred on August 25th 2022. However, those interested in participating in clinical studies may want to consider looking into 905 amyloidosis-related trials or 1296 drug research initiatives that are currently enrolling volunteers."
What common health issues are addressed through Pharmacological Study?
"Pharmacological Study is traditionally prescribed to treat synovitis, but it has also been found effective at treating ophthalmia and sympathetic disorders, as well as certain types of cancer like lung cancer and branch retinal vein occlusion."
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