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Corticosteroid
Isa-Pom-Dex for Multiple Myeloma
Phase 2
Recruiting
Led By Eben I Lichtman, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at the time of consent.
Documented symptomatic multiple myeloma that has previously responded to therapy (partial response or better) and is relapsed or relapsed and refractory to the last line of therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of a new combination treatment for advanced multiple myeloma that includes lower doses of two drugs.
Who is the study for?
This trial is for adults with relapsed or refractory multiple myeloma (RRMM) who have previously responded to therapy but are considered high-risk for severe toxicity from intensive treatments. They must not have had certain recent treatments, including monoclonal antibodies within the last 30 days and stem cell transplantation within the last 12 weeks.Check my eligibility
What is being tested?
The study tests a combination of isatuximab, pomalidomide, and dexamethasone at lower-than-standard doses in elderly/frail patients with RRMM. The goal is to evaluate safety and effectiveness when standard full-dose regimens pose too high a risk due to potential severe side effects.See study design
What are the potential side effects?
Potential side effects include immune system reactions, increased risk of infections, blood clots, bone marrow suppression leading to low blood cell counts, fatigue, nausea, diarrhea, and possibly others depending on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My multiple myeloma has come back or stopped responding after initially improving with treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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
Bone marrow minimal residual disease (MRD) negativity
Clinical benefit rate (CBR)
Duration of response
+8 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment3 Interventions
Subjects with relapsed or refractory multiple myeloma receiving the study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,284 Total Patients Enrolled
17 Trials studying Multiple Myeloma
21,963 Patients Enrolled for Multiple Myeloma
Genzyme, a Sanofi CompanyIndustry Sponsor
524 Previous Clinical Trials
85,580 Total Patients Enrolled
27 Trials studying Multiple Myeloma
9,765 Patients Enrolled for Multiple Myeloma
Eben I Lichtman, MDPrincipal InvestigatorUNC Lineberger Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had anti-CD38 therapy in the last 6 months.I responded to my last anti-CD38 treatment and haven't had it in 6 months.I am 18 years old or older.Your doctor believes that your overall health is too weak or fragile for any type of systemic treatment. This is often due to other health problems that are not related to the condition being studied.I am considered high risk for severe side effects from intense myeloma treatments.I had a stem cell transplant using my own cells within the last 12 weeks.My multiple myeloma has come back or stopped responding after initially improving with treatment.I haven't had myeloma treatment in the last 2 weeks.I have been treated with pomalidomide before.I haven't had monoclonal antibody therapy in the last 30 days.I have tried at least one treatment including an IMiD or PI for my condition without success.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arm
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 the Single Arm procedure compliant with FDA regulations?
"As this trial is in Phase 2, meaning there are some data supporting safety but none pertaining to efficacy, Single Arm's safety has been assigned a score of 2."
Answered by AI
Are there still opportunities to enroll in this clinical experiment?
"According to clinicaltrials.gov, this medical study has concluded recruitment. The trial was originally published on June 30th of 2023 and its last update occured on the 9th of June that same year. Fortunately, there are 1,078 other trials currently seeking participants at this time."
Answered by AI
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