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Proteasome Inhibitor
Isatuximab + Carfilzomib for Multiple Myeloma
Phase 1
Waitlist Available
Research Sponsored by Thomas Martin, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of multiple myeloma (MM) and documentation of treatment
For patients with platelets > 100,000 cells/ul, able to take aspirin daily as prophylactic anticoagulation therapy for ARM 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 1, 2, and 3 years from start of treatment
Awards & highlights
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.
Who is the study for?
This trial is for adults with multiple myeloma that has come back or hasn't responded to treatment. They should have had at least one but no more than three prior treatments and can't be very sick (ECOG <=2). People who've had certain other cancers, serious heart issues, or major procedures recently can't join. Participants need to understand the study and agree to use birth control if needed.Check my eligibility
What is being tested?
The trial tests a combination of drugs: Isatuximab (a monoclonal antibody), Carfilzomib (blocks cancer cell growth), Dexamethasone, and Lenalidomide (chemotherapy drugs). It aims to find the best dose of Isatuximab with these drugs in patients whose multiple myeloma has returned or is resistant.See study design
What are the potential side effects?
Possible side effects include immune system changes leading to organ inflammation, reactions during infusion into the body, increased risk of infections due to lowered immunity, potential blood disorders from chemotherapy agents like Dexamethasone and Lenalidomide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with multiple myeloma and have records of my treatment.
Select...
My platelet count is over 100,000 and I can take daily aspirin.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
My multiple myeloma has worsened or not responded to my last treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at 1, 2, and 3 years from start of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at 1, 2, and 3 years from start of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
ARM I: Incidence of Dose-Limiting Toxicities (DLT)
ARM I: Maximum tolerated dose (MTD) of isatuximab
ARM II: Overall Response Rate (ORR)
Secondary outcome measures
ARM I: Clinical benefit response (CBR)
ARM I: Incidence of isatuximab-specific antidrug antibodies (ADA)
ARM I: Overall Response Rate (ORR)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (40 mg dexamethasone, isatuximab, carfilzomib)Experimental Treatment3 Interventions
40 mg dexamethasone IV given on Days 1, 8, 15 and 22 (use as premed to isatuximab).
All patients will receive a fixed dose of Isatuximab (SAR650984) according to the assigned dose. Patients receive isatuximab IV over 4-6 hours on day 1, 3-4 hours on Day 8, 15, and 22 of cycle 1 and then on days 1 and 15 of subsequent cycle (patients may be eligible for rapid siatuximab given over 75 minutes), and carfilzomib IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm I (20 mg dexamethasone, isatuximab, carfilzomib)Experimental Treatment3 Interventions
20 mg dexamethasone IV given on days 1, 8, 15, 22 (pre- SAR650984 and carfilzomib), then dexamethasone 4 IV or PO mg Day 2, 9, 16.
All patients will receive a fixed dose of Isatuximab (SAR650984) according to their assigned dose cohort. Patients receive isatuximab IV over 4-6 hours on days 1 and 15 of every cycle for the starting cohort, and days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of subsequent cycles. Carfilzomib IV will be administered over 10 minutes on days 1, 2, 8, 9, 15, and 16 . Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may continue treatment after 8 courses if clinical benefit is present at the investigator's discretion (carfilzomib may be switched to days 1, 2, 15, and 16 after 8 cycles per investigator discretion).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Carfilzomib
2017
Completed Phase 3
~1440
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
Thomas Martin, MDLead Sponsor
3 Previous Clinical Trials
62 Total Patients Enrolled
3 Trials studying Multiple Myeloma
62 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,605 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,657 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,397 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,118 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (20 mg dexamethasone, isatuximab, carfilzomib)
- Group 2: Arm II (40 mg dexamethasone, isatuximab, carfilzomib)
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.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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