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Isatuximab + Carfilzomib for Multiple Myeloma
Study Summary
This trial is testing isatuximab given with carfilzomib, with or without dexamethasone and lenalidomide, to see what effects, good and bad, it has in treating patients with multiple myeloma that has come back or did not respond to previous treatment.
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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Who is running the clinical trial?
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- You need to have specific test results from a clinical laboratory.I have had serious heart issues or a heart attack in the last 6 months, or my high blood pressure is not well controlled.I do not have severe or painful nerve damage.You have a medical condition that can be measured using specific guidelines.I am following the required pregnancy prevention measures.I had a stem cell transplant less than 12 weeks ago.I am currently being treated for an active infection.I am 18 years old or older.I have had 1-3 treatments for myeloma, am not resistant to carfilzomib, and it's been 8+ weeks since my last carfilzomib treatment.I haven't had or been treated for another cancer in the last 3 years.I've had at least 2 treatments including IMiD and PI, and possibly a bone marrow transplant over 12 weeks ago.My platelet count is over 100,000 and I can take daily aspirin.I haven't had radiation, chemo, or major surgery in the last 2-4 weeks.I have been diagnosed with multiple myeloma and have records of my treatment.You are allergic to specific parts of the study treatment.I understand the study's purpose and risks and have given my consent in writing.I have no stomach or intestine problems.I have had significant bleeding inside my body.I have HIV or active hepatitis B or C.I am mostly self-sufficient and can carry out daily activities.My multiple myeloma has worsened or not responded to my last treatment.You have a severe mental illness, or struggle with alcohol or drug addiction.I take more than 10 mg of prednisone or its equivalent daily.
- Group 1: Arm I (20 mg dexamethasone, isatuximab, carfilzomib)
- Group 2: Arm II (40 mg dexamethasone, isatuximab, carfilzomib)
- 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
Has the Food and Drug Administration given its blessing to Carfilzomib?
"Carfilzomib's safety is assessed as a 1 on our rating scale, indicating that there are only limited data points to suggest efficacy and drug security."
Are there still openings available to enrollees in this trial?
"Clinicaltrials.gov demonstrates that this healthcare research is still in the recruitment phase, with a first posting date of January 21st 2015 and an edit as recent as July 3rd 2022."
What indications is Carfilzomib typically employed to treat?
"Carfilzomib is typically given to those suffering from ophthalmia and sympathetic. This medication can also be used to treat branch retinal vein occlusion, macular edema, as well as communicable illnesses."
What other researches have been conducted regarding Carfilzomib?
"Presently, 579 medical trials are underway for Carfilzomib, with 146 of those being in the third stage. A majority of these studies take place near Mishawaka, Indiana; however 19278 other sites around the world have clinical research projects dedicated to this drug's efficacy."
Is this research endeavor being implemented in various healthcare establishments across the US?
"This research project is being administered at a quartet of clinical sites, such as the University of California in San Francisco, Icahn School of Medicine situated in New york City, Hackensack University Medical Center located near Hackensack and 4 other associated medical facilities."
What is the current size of this trial's participant base?
"Affirmative. Clinicaltrials.gov reveals that this clinical trial is open for recruitment, having first been posted on January 21st 2015 and last updated July 3rd 2022. The research requires 89 participants to be sourced from four sites."
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