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Monoclonal Antibodies
Triple Therapy for Multiple Myeloma
Phase 1 & 2
Waitlist Available
Led By Shaji K. Kumar, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease
All prior treatment-related toxicities (defined by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE), version 5.0) must be =< grade 1 at the time of enrolment except for alopecia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is studying the best dose and effect of belantamab mafodotin given with lenalidomide and daratumumab in treating patients with multiple myeloma.
Who is the study for?
Adults with relapsed, refractory, or untreated multiple myeloma who've had at least one prior therapy including a proteasome inhibitor and an immunomodulatory drug. They must have measurable disease, be in good physical condition (ECOG PS 0-2), not pregnant or breastfeeding, willing to provide samples for research, and meet specific blood count and organ function criteria. Exclusions include recent major surgery, other cancers within 2 years (except certain cases), concurrent treatments for multiple myeloma, HIV positive status, active renal conditions or severe liver disease.Check my eligibility
What is being tested?
The trial is testing the combination of belantamab mafodotin (a monoclonal antibody linked to chemotherapy) with lenalidomide (an immune system modulator) and daratumumab (another monoclonal antibody) on patients with multiple myeloma. It aims to determine the best dose and observe how well this combination works against cancer cells that express BCMA receptors.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to treatment such as infusion-related reactions from antibodies; effects from chemotherapy like nausea or hair loss; changes in blood counts leading to increased infection risk; eye problems due to belantamab mafodotin; fatigue; digestive issues; and possible impact on liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by tests.
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All my side effects from previous cancer treatments are mild, except for hair loss.
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I am a male willing to follow specific guidelines to prevent pregnancy during and after treatment.
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I have multiple myeloma that didn't respond to treatment including a proteasome inhibitor and lenalidomide.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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
Complete response rate with belantamab, daratumumab, and lenalidomide, OR alternating cycles of daratumumab, lenalidomide, dexamethasone and belantamab, lenalidomide and dexamethasone, when used as initial therapy (Phase II)
Maximum tolerated dose (MTD) of belantamab in combination with daratumumab and lenalidomide in patients with relapsed and/or refractory multiple myeloma (Phase I)
Secondary outcome measures
Greater than or equal to very good partial response (VGPR) rate
Incidence of adverse events
Incidence of toxicity (Phase I)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm B (belantamab mafodotin, lenalidomide, daratumumab, Dxevo)Experimental Treatment10 Interventions
INDUCTION: Patients receive belantamab mafodotin IV over 30 minutes on day 1 of cycles 2, 4, 6, 8, 10, and 12, lenalidomide PO QD on days 1-21, daratumumab IV over 90 minutes on days 1, 8, 15, and 22 of cycles 1 and 3, and days 1 and 15 on cycles 5, 7, 9, and 11. Patients also receive dexamethasone PO on days 1, 8, 15 and 22. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Beginning cycle 13, patients receive belantamab mafodotin IV over 30 minutes on day 1 of even numbered cycles, lenalidomide PO QD on days 1-21, and daratumumab IV over 90 minutes on day 1 of odd numbered cycles. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Group II: Arm A (belantamab mafodotin, lenalidomide, daratumumab)Experimental Treatment9 Interventions
INDUCTION: Patients receive belantamab mafodotin IV over 30 minutes on day 1 of odd number cycles, lenalidomide PO QD on days 1-21, and daratumumab IV over 90 minutes on days 1, 8, 15, and 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Beginning cycle 13, patients receive belantamab mafodotin IV over 30 minutes on day 1 of odd number cycles (starting cycle 13), lenalidomide PO QD on days 1-21, and daratumumab IV over 90 minutes on day 1. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Dexamethasone
2007
Completed Phase 4
~2590
Skeletal Survey X-Ray
2021
Completed Phase 2
~10
Bone Marrow Aspiration
2011
Completed Phase 2
~1740
Low Dose Computed Tomography of the Whole Body
2021
Completed Phase 2
~10
Bone Marrow Biopsy
2021
Completed Phase 2
~10
Belantamab Mafodotin
2021
Completed Phase 2
~10
Daratumumab
2014
Completed Phase 3
~1860
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,662 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,125 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,078 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,706 Patients Enrolled for Multiple Myeloma
Shaji K. Kumar, M.D.Principal InvestigatorMayo Clinic in Rochester
8 Previous Clinical Trials
2,774 Total Patients Enrolled
8 Trials studying Multiple Myeloma
2,774 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by tests.I am at risk for heart disease.All my side effects from previous cancer treatments are mild, except for hair loss.Your absolute neutrophil count is at least 1200 per cubic millimeter within the past 14 days.I am HIV positive.I have not had plasmapheresis in the last 14 days.I am not pregnant or breastfeeding.I am not currently on any other treatments for my multiple myeloma.I have a stomach condition or surgery that may affect how I absorb pills.I am a male willing to follow specific guidelines to prevent pregnancy during and after treatment.My blood clotting tests are normal or managed if I'm on blood thinners.I do not have serious liver problems like ascites, jaundice, or cirrhosis.You have tested positive for hepatitis C within the past 3 months.I am not allergic to corticosteroids, monoclonal antibodies, human proteins, or their components.I have a corneal condition, but it's not severe.You do not have hepatitis B, as shown by a negative test for hepatitis B surface antigen or antibodies to hepatitis B surface and/or core antigens.I have multiple myeloma that didn't respond to treatment including a proteasome inhibitor and lenalidomide.I have not had major surgery in the last 28 days.I have a precancerous condition of the bone marrow.I haven't had or been treated for another cancer within the last 2 years.Your platelet count should be at least 100,000 per cubic millimeter.I do not have any active kidney problems that could affect my safety in the study.I am 18 years old or older.I do not have any uncontrolled illnesses.I have had radiation therapy for a single bone marrow tumor.I am able to care for myself and perform daily activities.Your hemoglobin level is at least 9.0 grams per deciliter.I have multiple myeloma and have had little to no treatment.Your kidneys are working well enough, as shown by a recent test.Your total bilirubin level must be within a certain range, as measured in a blood test taken within the last two weeks.Your liver enzyme levels are not too high, unless you have liver involvement, in which case they can be a little higher.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (belantamab mafodotin, lenalidomide, daratumumab, Dxevo)
- Group 2: Arm A (belantamab mafodotin, lenalidomide, daratumumab)
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.
For what medical purposes is Daratumumab most commonly prescribed?
"Daratumumab is indicated for the treatment of ophthalmia, sympathetic. It can also help patients who have received at least two rounds of prior systemic chemotherapy, those with branch retinal vein occlusion, and macular edema."
Answered by AI
Can people with certain medical conditions participate in this research?
"From the information available on clinicaltrials.gov, it seems that this clinical trial is still in need of patients. This particular trial was first posted on 6/4/2021 and underwent its most recent edit on 6/10/2022."
Answered by AI
What are the goals that this clinical trial is hoping to achieve?
"The primary objective of this 28-day clinical trial is to observe the complete response rate in patients that receive belantamab, daratumumab, and lenalidomide as initial therapy. Secondary objectives include measuring progression-free survival and overall response rate."
Answered by AI
How many individuals are enrolled in this clinical trial?
"Yes, the trial is still open to new participants. According to the clinicaltrials.gov website, the study was first posted on June 4th, 2021 and last updated on June 10th, 2022. Right now, the study only needs 12 more patients at a single enrolment site."
Answered by AI
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