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Monoclonal Antibodies
Belantamab Mafodotin + Lenalidomide for Multiple Myeloma
Phase 2
Recruiting
Led By Jens Hillengass
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG), 2016 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from the start of consolidation until death due to any cause or last follow-up, assessed up to 5 years
Awards & highlights
Study Summary
This trial is testing the effectiveness of belantamab mafodotin, a targeted therapy, in combination with lenalidomide, a standard of care treatment, for patients with multiple myeloma who have minimal residual disease.
Who is the study for?
Adults diagnosed with multiple myeloma who still have minimal residual disease after a stem cell transplant can join. They should be in good enough health to perform daily activities, not pregnant or breastfeeding, and willing to use contraception. People with recent major surgery, active bleeding, severe liver conditions, certain infections like HIV or hepatitis B/C, or poor vision are excluded.Check my eligibility
What is being tested?
The trial is testing the combination of Belantamab Mafodotin (a targeted therapy) and Lenalidomide (a standard cancer treatment) on patients whose multiple myeloma isn't fully gone after a stem cell transplant. The goal is to see if this combo helps eliminate the remaining cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions at the infusion site for Belantamab Mafodotin, blurred vision due to eye-related toxicity, fatigue from both drugs, blood disorders such as low counts of different types of blood cells caused by Lenalidomide and potential risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to get out of my bed or chair and move around.
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My condition is officially diagnosed as multiple myeloma.
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I am 18 years old or older.
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I still have detectable cancer cells after intensive chemotherapy.
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All my side effects from previous cancer treatments are mild, except for hair loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from the start of consolidation until death due to any cause or last follow-up, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from the start of consolidation until death due to any cause or last follow-up, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Minimal residual disease (MRD) negative rate
Secondary outcome measures
Overall survival
Progression-free survival
Sustained MRD negative rate
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (belantamab mafodotin, lenalidomide)Experimental Treatment2 Interventions
Patients receive belantamab mafodotin IV over 30 minutes on day 1 and lenalidomide PO QD on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab Mafodotin
2021
Completed Phase 2
~10
Lenalidomide
2005
Completed Phase 3
~1480
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,838 Total Patients Enrolled
20 Trials studying Multiple Myeloma
2,080 Patients Enrolled for Multiple Myeloma
GlaxoSmithKlineIndustry Sponsor
4,753 Previous Clinical Trials
8,069,438 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,413 Patients Enrolled for Multiple Myeloma
Jens HillengassPrincipal InvestigatorRoswell Park Cancer Institute
3 Previous Clinical Trials
228 Total Patients Enrolled
3 Trials studying Multiple Myeloma
228 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken any experimental drugs or monoclonal antibodies recently.I am able to get out of my bed or chair and move around.I have tested positive for hepatitis C recently or had it in the past but now cleared.I am currently pregnant or breastfeeding.I am not pregnant or breastfeeding, and if able to have children, I agree to use contraception.I have another cancer type that's been stable for 2 years or is a treated skin cancer.I have serious heart issues or uncontrolled high blood pressure.Your vision in your worst eye is worse than 20/100, except if it's because of a treatable condition like cataracts within the last 6 months.Your hemoglobin level is at least 8.0 grams per deciliter within 14 days before starting the study treatment.My liver condition is stable and does not include severe symptoms like ascites or jaundice.Your liver enzyme levels are not too high, unless there is evidence of liver disease.I have tested positive for hepatitis B recently.I am HIV positive.My condition worsened after treatment with belantamab mafodotin.Your platelet count is at least 75 billion per liter within 14 days before starting the study treatment.Your total bilirubin level must be within a certain range, and if it's slightly higher, a specific type of bilirubin must be within a normal range.I have a kidney condition but it's only protein in my urine due to my cancer.I am currently on treatment for an active infection.My condition is officially diagnosed as multiple myeloma.I have not undergone plasmapheresis in the last 7 days.I haven't needed treatment for bleeding in the last 4 weeks.I have not had major surgery in the last four weeks.Your kidney function is good, with an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m^2 within 14 days before starting the study treatment.Your white blood cell count is normal.I am 18 years old or older.I still have detectable cancer cells after intensive chemotherapy.I am allergic to drugs similar to belantamab mafodotin or lenalidomide.My kidney tests show normal protein levels in my urine.I agree to use contraception or remain abstinent for 6 months after treatment.I have a mild eye surface condition.All my side effects from previous cancer treatments are mild, except for hair loss.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (belantamab mafodotin, lenalidomide)
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.
Are there still opportunities for individuals to partake in this experiment?
"This clinical trial is no longer taking applications; it was first advertised on the 12th of December 2022 and last updated on October 17th 2022. If you are looking for other trials, there are presently 818 studies searching for multiple myeloma candidates and 292 recruiting patients to take Belantamab Mafodotin medication."
Answered by AI
Has Belantamab Mafodotin received the sanction of the FDA?
"There is some evidence of Belantamab Mafodotin's safety, which warrants it a score of 2 on the Power assessment scale. Currently, there are no clinical data points to support its efficacy."
Answered by AI
What health issues does Belantamab Mafodotin typically treat?
"Belantamab Mafodotin is a viable therapeutic option for those suffering from chronic lymphocytic leukemia, amyloidosis, and certain cases of relapsed or refractory multiple myeloma. It has been known to be effective after at least two courses of systemic chemotherapy."
Answered by AI
How many participants are eligible for inclusion in this investigation?
"At this juncture, this particular trial is not accepting patient enrolment. It was first published on December 1st 2022 and the latest update to its parameters occurred on October 17th of the same year. For those seeking alternative trials, 818 have opened their doors for patients with multiple myeloma while 292 are presently recruiting participants that wish to receive Belantamab Mafodotin."
Answered by AI
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