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Proteasome Inhibitor
Isatuximab + Carfilzomib + Pomalidomide for Multiple Myeloma
Phase 2
Waitlist Available
Led By Rebecca W Silbermann
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 50%)
- Creatinine clearance (CrCl) of >= 30 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study treatment until death or last known alive (censored), assessed up to 24 months
Awards & highlights
Study Summary
This trial is testing isatuximab, carfilzomib, and pomalidomide to see if they can treat patients with multiple myeloma that has come back or does not respond to treatment.
Who is the study for?
Adults with relapsed or refractory multiple myeloma, who have had at least one prior therapy, can join this trial. They must have good liver and kidney function, no severe heart issues, and not be pregnant or breastfeeding. Participants should agree to use effective contraception and not have any allergies to the drugs being tested.Check my eligibility
What is being tested?
The trial is testing a combination of three treatments: Isatuximab (a monoclonal antibody), Carfilzomib (an enzyme blocker), and Pomalidomide (a chemotherapy drug). It aims to see if this trio is effective in treating patients whose multiple myeloma has returned or resisted other treatments.See study design
What are the potential side effects?
Possible side effects include immune system reactions, fatigue, nausea, risk of infections due to low blood cell counts, potential heart problems like hypertension or arrhythmias, as well as liver-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My kidneys are functioning well enough (CrCl >= 30 mL/min).
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My diagnosis of multiple myeloma is confirmed by lab tests.
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I am 18 years old or older.
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My multiple myeloma has returned after treatment.
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My blood and organs are functioning normally.
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I can safely receive blood clot prevention treatment for pomalidomide.
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I have undergone at least one treatment for my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study treatment until death or last known alive (censored), assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study treatment until death or last known alive (censored), assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Incidence of grade > 2 toxicities
Overall survival
+2 moreOther outcome measures
Frequency of minimal residual disease negative remissions at time of complete response
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (isatuximab, carfilzomib, pomalidomide)Experimental Treatment3 Interventions
Patients receive isatuximab IV over 30-60 minutes on days 1, 8, 15, and 22 of cycle 1, and days 1 and 15 of subsequent cycles, carfilzomib IV over 10 to 30 minutes on days 1, 8, 15, and pomalidomide PO QD on days 1-21. 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
Carfilzomib
2017
Completed Phase 3
~1440
Isatuximab
2016
Completed Phase 3
~370
Pomalidomide
2011
Completed Phase 2
~1020
Find a Location
Who is running the clinical trial?
Oregon Health and Science UniversityOTHER
973 Previous Clinical Trials
6,846,024 Total Patients Enrolled
4 Trials studying Multiple Myeloma
33 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,163 Previous Clinical Trials
3,512,475 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,196 Patients Enrolled for Multiple Myeloma
OHSU Knight Cancer InstituteLead Sponsor
230 Previous Clinical Trials
2,090,721 Total Patients Enrolled
12 Trials studying Multiple Myeloma
1,584 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will use effective birth control during and for 3 months after the study.I have not received a live vaccine in the last 30 days.I am experiencing side effects from my previous myeloma treatment.I have had a stem cell transplant from a donor.I am allergic to Captisol, a substance used in some cancer drugs.I am currently using steroids, but only in forms that don't affect my whole body.I haven't had cancer treatment or radiation in the last 2 weeks or longer, depending on the treatment type.I am HIV positive.I agree to use birth control during and for 3 months after the study.I have an autoimmune disease, but it's not vitiligo or hypothyroidism.You have an abnormal level of a specific type of protein in your blood.Your heart's pumping function is at least 40%, as measured by an echocardiogram.I can take care of myself but might not be able to do heavy physical work.Your liver enzymes (AST and ALT) are not more than twice the normal level.I do not have any uncontrolled heart or blood pressure problems.Your total bilirubin level is within the normal range for the hospital's standards.You have a disease that can be measured by the doctor.I am not allergic to isatuximab or similar cancer treatments.I currently have an infection that affects my whole body.My liver is working well.You have hepatitis C virus in your blood, unless you have successfully completed treatment and the virus has stayed away for at least 12 weeks.You need to have a certain level of white blood cells called neutrophils in your blood.I have a high number of plasma cells in my blood.I have tested positive for hepatitis B or have been vaccinated against it.My kidneys are functioning well enough (CrCl >= 30 mL/min).You have a high level of a specific protein in your urine.My condition did not improve after treatment with carfilzomib or pomalidomide.I had a stem cell transplant using my own cells within the last 3 months.I have POEMS syndrome.Your hemoglobin level is at least 8.0 grams per deciliter within 14 days before joining the study.I have another cancer besides non-melanoma skin cancer, treated over 5 years ago or approved by the PI.I have or had lung inflammation treated with steroids.My diagnosis of multiple myeloma is confirmed by lab tests.Your platelet count is at least 75,000 per microliter within 14 days before joining the study.Your free light chain levels are too high and your serum free light chain ratio is abnormal.I have not taken immunosuppressive drugs in the last 7 days.I am 18 years old or older.My multiple myeloma has returned after treatment.My blood and organs are functioning normally.I have been diagnosed with myelodysplastic syndrome.I have or might have amyloidosis.My multiple myeloma is of the IgM subtype.I have been diagnosed with Waldenstrom macroglobulinemia.I can safely receive blood clot prevention treatment for pomalidomide.Side effects from my previous treatments have mostly gone away.My kidney function is within normal ranges.I had to stop taking carfilzomib or pomalidomide due to side effects.I have undergone at least one treatment for my condition.You are allergic to any of the ingredients in the study treatment and cannot take steroids and H2 blockers before the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (isatuximab, carfilzomib, pomalidomide)
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.
Could you outline any prior trials involving Pomalidomide?
"Currently, 184 medical trials are underway to study the effectiveness of pomalidomide. In Phase 3 alone, 26 studies have been initiated in Harrison, New york and 6357 other sites around the world."
Answered by AI
How many patients are being administered the treatment in this clinical experiment?
"Affirmative - according to the data posted on clinicaltrials.gov, this medical experiment is presently seeking volunteers. It was initially shared on June 14th 2022 and updated for the last time that same day. A total of 44 participants are necessary from a single recruitment centre."
Answered by AI
Is admission to this research endeavor available at the present time?
"Per clinicaltrials.gov, this medical experiment is still in search of participants. The trial was initially posted on June 14th 2022 and has been modified since then as recently as the same date."
Answered by AI
Has the FDA sanctioned Pomalidomide for medicinal use?
"Pomalidomide was assigned a score of 2 on our safety scale, as there is evidence to back its security but not yet any clinical efficacy data."
Answered by AI
How pioneering is this clinical research?
"Since its original scientific research in 2010, sponsored by Sanofi and involving 351 participants, pomalidomide has gained Phase 1 & 2 drug approval. Nowadays there are an impressive 184 active clinical trials for this medication spread across 49 countries and 1055 cities."
Answered by AI
What are the primary maladies that Pomalidomide is utilized to address?
"Patients with active multiple myeloma, refractory or relapsed forms of this cancer can be treated using Pomalidomide."
Answered by AI
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