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Monoclonal Antibody
Quadruple Therapy for Multiple Myeloma
Phase 1 & 2
Recruiting
Led By Shebli Atrash, MD, MS
Research Sponsored by Shebli Atrash
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Active, newly diagnosed multiple myeloma with CRAB features or a myeloma-defining event per the IMWG 2014 criteria
ECOG Performance Status of less than or equal to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Study Summary
This trial is testing a new drug combo for multiple myeloma to see if it's effective and has any harmful side effects.
Who is the study for?
Adults with multiple myeloma who've had at least one prior therapy can join this trial. They must have good organ function, agree to use effective contraception, and not be pregnant or breastfeeding. People with certain heart, lung, kidney conditions, active infections or other recent cancers aren't eligible. Participants need to avoid contact lenses and haven't received certain treatments recently.Check my eligibility
What is being tested?
The study is testing the effectiveness of belantamab mafodotin combined with carfilzomib, lenalidomide, and dexamethasone in treating multiple myeloma. It aims to see if this drug combo improves patient outcomes compared to current standard treatments.See study design
What are the potential side effects?
Potential side effects include reactions related to infusion of the drugs, changes in blood counts leading to increased infection risk or bleeding tendencies, fatigue, digestive issues like nausea or diarrhea; as well as possible eye problems due to belantamab mafodotin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been recently diagnosed with active multiple myeloma.
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I can take care of myself but might not be able to do heavy physical work.
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I have had at least one treatment for my multiple myeloma.
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My condition is considered high-risk due to specific genetic changes.
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My heart pumps well, with an ejection fraction over 40%.
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I have not had chemotherapy in the last 14 days and have recovered from its side effects.
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I agree not to donate sperm and to use effective birth control.
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I have not worsened while on a full dose of lenalidomide.
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I am 18 years old or older.
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I can swallow pills.
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My lung function is at least half of what is expected for someone my age and size.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish Maximum Tolerated Dose (MTD)
Evaluate Complete Response (CR)
Secondary outcome measures
Best Response
Complete Response (CR)
Duration of Response (DoR)
+8 moreOther outcome measures
Safety - Adverse Events (AEs)
Safety - Adverse Events of Special Interest (AESIs)
Safety - Serious Adverse Events (SAEs)
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Phase IIExperimental Treatment1 Intervention
Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin
Group II: Phase IExperimental Treatment1 Intervention
Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin
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Who is running the clinical trial?
Shebli AtrashLead Sponsor
2 Previous Clinical Trials
12 Total Patients Enrolled
2 Trials studying Multiple Myeloma
12 Patients Enrolled for Multiple Myeloma
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,137 Total Patients Enrolled
17 Trials studying Multiple Myeloma
3,181 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,370 Previous Clinical Trials
1,377,618 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,670 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been recently diagnosed with active multiple myeloma.I have not undergone plasmapheresis in the last 7 days.I haven't had cancer in the last 5 years, except for skin cancer.I have moderate to severe numbness, tingling, or pain in my hands or feet.I can take care of myself but might not be able to do heavy physical work.I agree not to donate eggs during and for 4 months after my treatment ends.I stopped taking carfilzomib, lenalidomide, or dexamethasone due to side effects.You have tested positive for hepatitis C or have had a positive test result for hepatitis C within the last 3 months before starting the study treatment.I have not received any live vaccines in the last 30 days.I have had at least one treatment for my multiple myeloma.You have tested positive for hepatitis B.I have AL amyloidosis or POEMS syndrome.I have had only one treatment cycle for my multiple myeloma.My condition is considered high-risk due to specific genetic changes.You have specific levels of certain proteins in your blood or urine that indicate the presence of the disease.My heart pumps well, with an ejection fraction over 40%.I have an ongoing kidney condition.I am currently on medication for an infection.I haven't taken any experimental drugs recently.I have had a condition where my lymphocytes grow abnormally.My cancer has spread to my brain or spinal cord.I have not had chemotherapy in the last 14 days and have recovered from its side effects.I can follow the study's procedures for its duration.I have not had radiation therapy in the last 14 days.I have a serious heart condition.I have been diagnosed with HIV.My organs are functioning well.I have been diagnosed with plasma cell leukemia.I have not had major surgery in the last 4 weeks.My liver condition is currently unstable.I haven't had monoclonal antibody treatment in the last 30 days.I agree not to donate sperm and to use effective birth control.I have not worsened while on a full dose of lenalidomide.I am 18 years old or older.I can swallow pills.I have a history of cancer.I am currently experiencing bleeding from internal organs or mucous membranes.You have had a skin condition called erythema multiforme from taking lenalidomide or similar medications.I have a mild eye surface condition.My lung function is at least half of what is expected for someone my age and size.
Research Study Groups:
This trial has the following groups:- Group 1: Phase I
- Group 2: Phase II
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.
What are the end goals of this experiment?
"This five-year clinical trial seeks to identify Maximum Tolerated Dose (MTD), whilst also assessing secondary outcomes such as Time to Progression, Overall Survival and Duration of Response. Specifically, the latter is calculated for each participant who achieves a Partial Response or better from their first assessment until either disease progression or death occurs."
Answered by AI
Is this survey of medical participants currently recruiting?
"Affirmative. Clinicaltrials.gov indicates that this clinical trial is in the midst of recruitment, having been posted on April 13th 2021 and last updated October 26th 2022. There are 70 places available at a single location for participants to join in."
Answered by AI
What is the total enrollment figure for this scientific experiment?
"Affirmative. Accessing the clinicaltrials.gov website reveals that this trial is actively attempting to recruit patients, having been posted on April 13th 2021 and recently updated October 26th 2022. 70 participants are needed for the single location of enrolment."
Answered by AI
What indications are most frequently treated with Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin?
"Ophthalmic sympathetic ophthalmia is traditionally managed with the combination of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin. This concoction may also prove beneficial for managing conditions such as branch retinal vein occlusion, macular edema or cases that have seen two prior systemic chemotherapy regimens."
Answered by AI
Are there any documented occurrences of utilizing Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin in a medical test?
"Currently, there are 721 clinical studies in existence that investigate the efficacy of Carfilzomib, Lenalidomide, Dexamethasone and Belantamab Mafodotin. Out of those trials, 168 have passed into Phase 3. The primary research centre for these treatments is based in Joliet, Illinois; however additional locations across 25802 cities are running their own experiments too."
Answered by AI
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