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Isatuximab + Lenalidomide for Multiple Myeloma
Phase 2
Recruiting
Led By Muzzaffar Qazilbash, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult patients 18 to 70 years old, with newly diagnosed symptomatic myeloma
Subjects must have high-risk myeloma as defined by specific criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
Study Summary
This trial will test if isatuximab, with lenalidomide, can help treat highrisk multiple myeloma post-stem cell transplant.
Who is the study for?
This trial is for adults aged 18-70 with newly diagnosed high-risk multiple myeloma who've had a partial response or better after stem cell transplant. They must have adequate organ function, agree to birth control measures, and not be pregnant or breastfeeding. Excluded are those with progressing myeloma, recent major surgery, active infections requiring treatment, known drug allergies relevant to the study drugs, or HIV/hepatitis.Check my eligibility
What is being tested?
The trial tests if adding Isatuximab to Lenalidomide as maintenance therapy post-stem cell transplant can help control high-risk multiple myeloma. Participants will receive this combination treatment and their disease progression will be monitored.See study design
What are the potential side effects?
Possible side effects of Isatuximab plus Lenalidomide may include infusion reactions from Isatuximab and blood disorders, fatigue, digestive issues like diarrhea or constipation from Lenalidomide. There's also a risk of infection due to immune system effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old with newly diagnosed myeloma.
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My myeloma is classified as high-risk.
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I can care for myself but may not be able to do active work.
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I agree to use birth control and not donate sperm.
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My cancer responded well to initial treatments.
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I am not pregnant or breastfeeding and will follow the birth control requirements.
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I had a stem cell transplant with the right preparation and my cell counts recovered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5
Trial Design
1Treatment groups
Experimental Treatment
Group I: isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT)Experimental Treatment2 Interventions
Both isatuximab and lenalidomide are FDA approved and commercially available for the treatment of relapsed or refractory MM (MM that has come back or stopped responding to treatment). Participants will begin taking the study drugs about 60-180 days after your ASCT. Participants may receive the study drugs for about 3 years. After that, participants will have follow-up visits 1 time a year for the 3 years after your last dose of study drugs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
lenalidomide
2012
Completed Phase 3
~3920
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,974 Previous Clinical Trials
1,789,415 Total Patients Enrolled
76 Trials studying Multiple Myeloma
5,756 Patients Enrolled for Multiple Myeloma
SanofiIndustry Sponsor
2,164 Previous Clinical Trials
3,514,919 Total Patients Enrolled
47 Trials studying Multiple Myeloma
10,140 Patients Enrolled for Multiple Myeloma
Muzzaffar Qazilbash, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood counts need to meet certain requirements.I am between 18 and 70 years old with newly diagnosed myeloma.You must have a detectable disease as defined by specific criteria when you are diagnosed.I can communicate in English or another language.I have allergies to drugs similar to the ones used in this study.My myeloma is classified as high-risk.I do not have any uncontrolled illnesses.I can care for myself but may not be able to do active work.My major organs are functioning well.I have not had major surgery in the last 4 weeks.I agree to use birth control and not donate sperm.My myeloma worsened before starting maintenance treatment.I am currently being treated for an infection.You have had a severe allergic reaction or skin rash to certain medications.My cancer responded well to initial treatments.I am not pregnant or breastfeeding and will follow the birth control requirements.I had a stem cell transplant with the right preparation and my cell counts recovered.I am HIV-positive or have active hepatitis A, B, or C.
Research Study Groups:
This trial has the following groups:- Group 1: isatuximab plus lenalidomide after an autologous stem cell transplantation (ASCT)
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 eligibility for this clinical study confined to adults, or are minors also allowed to participate?
"The parameters for enrolment into this clinical trial state that the minimum age is 18 and no more than 70 years old."
Answered by AI
Are there opportunities for individuals to join this research endeavor?
"Evidently, this clinical research is currently not seeking participants as the last update was on March 8th of 2023. Initially posted in September 30th 2023, there are presently 810 other studies actively enrolling patients."
Answered by AI
Who is able to sign up for the research protocol?
"This medical trial seeks 61 individuals with multiple myeloma aged between 18 and 70."
Answered by AI
Has the FDA accorded its blessing to isatuximab combined with lenalidomide post-autologous stem cell transplantation?
"Our experts at Power assessed the safety of isatuximab plus lenalidomide after an autologous stem cell transplantation to be a 2 on a scale from 1-3. This decision was based off the Phase 2 trial data, which confirms safety but does not yet prove efficacy."
Answered by AI
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