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Monoclonal Antibodies
Belantamab Mafodotin + Pomalidomide + Dexamethasone for Multiple Myeloma
Phase 2
Recruiting
Led By Ajay K. Nooka, MD,MPH,FACP
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All prior treatment-related toxicities (defined by National Cancer Institute- Common Toxicity Criteria for Adverse Events [NCI-CTCAE], version 4.03) must be =< grade 1 at the time of enrolment except for alopecia
Participant must be >= 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a combination of drugs to treat patients with high-risk myeloma. The drugs work in different ways to kill cancer cells or stop their growth.
Who is the study for?
This trial is for adults over 18 with high-risk myeloma who've had a stem cell transplant within the last year and are not pregnant or breastfeeding. They should have certain genetic markers, good organ function, no severe eye disease, infections, or allergies to study drugs. Participants must agree to use contraception.Check my eligibility
What is being tested?
The trial tests belantamab mafodotin (a targeted antibody-chemotherapy combo), pomalidomide (a chemotherapy drug), and dexamethasone (an anti-inflammatory) in treating high-risk myeloma patients to see if this combination kills more cancer cells.See study design
What are the potential side effects?
Potential side effects include vision problems due to corneal changes, liver issues like jaundice or cirrhosis, kidney problems requiring dialysis, nerve damage causing neuropathy, bleeding risks from blood disorders and allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
All my side effects from previous cancer treatments are mild, except for hair loss.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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My blood test shows 20% or more plasma cells.
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My cancer is high-risk due to specific genetic changes.
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I have had a hysterectomy, both ovaries removed, or my tubes tied, with documentation.
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
Secondary outcome measures
Duration of response
Incidence of adverse events
Minimal residual disease (MRD) negativity rate
+5 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (belantamab mafodotin, pomalidomide, dexamethasone)Experimental Treatment3 Interventions
Patients receive belantamab mafodotin IV over 30 minutes on day 1 of every other cycle, pomalidomide PO QD on days 1-21, and dexamethasone PO QD on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Belantamab Mafodotin
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,662 Total Patients Enrolled
25 Trials studying Multiple Myeloma
1,945 Patients Enrolled for Multiple Myeloma
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,782 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,399 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,820 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,097 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- All my side effects from previous cancer treatments are mild, except for hair loss.I am not allergic to belantamab mafodotin or similar drugs.I am 18 years old or older.I do not have any infections that need treatment.Your white blood cell count is at least 1.5 x 10^9 per liter.I can take care of myself and am up and about more than half of my waking hours.I do not have hepatitis B, or if I do, I meet specific health criteria.I have been diagnosed with a specific blood or bone marrow condition.Your alanine aminotransferase (ALT) levels are not more than 2.5 times the upper limit of normal.I haven't had monoclonal antibody treatment in the last 30 days.My blood test shows 20% or more plasma cells.I do not have any known heart risks.You have tested positive for hepatitis C within the last 3 months.You have HIV, unless you meet specific criteria.I have not undergone plasmapheresis in the last 7 days.I haven't taken any experimental drugs or standard myeloma treatments in the last 14 days.Your urine test shows that the amount of albumin compared to creatinine is less than 500 mg/g (56 mg/mmol).My cancer is high-risk due to specific genetic changes.I have had a hysterectomy, both ovaries removed, or my tubes tied, with documentation.I am a male and agree to follow the required contraceptive guidelines during and 6 months after the study.I do not have any serious eye surface diseases.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have any active kidney problems affecting my safety, except for protein in my urine due to multiple myeloma.I have no other cancers, or they've been stable for 2 years, except for treated non-melanoma skin cancer.I am not allergic to the study drugs or similar compounds.Your hemoglobin level should be at least 8.0 grams per deciliter within the last 28 days before starting the treatment.Your total bilirubin level should be no more than 1.5 times the upper limit of normal. If your isolated bilirubin level is higher, it's okay if the direct bilirubin level is less than 35%. This test should be done within 28 days before starting the treatment.I am not pregnant or breastfeeding and follow local birth control guidelines.Your kidneys are working well, with an estimated filtration rate of at least 30 mL per minute, based on a recent test.I had a stem cell transplant for my myeloma within a year of diagnosis and have seen improvement.I am at high risk and did not reach partial remission after my stem cell transplant.You have had a bad reaction to steroid treatment in the past.I have not had major surgery in the last 4 weeks.I cannot take certain blood thinners due to allergies or side effects.I have a known brain or spinal cord condition.You have had a bad reaction to acyclovir or a similar antiviral medication in the past.Your platelet count is at least 75 x 10^9 per liter of blood.I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that didn't spread.I do not have any current bleeding from my internal organs or mucous membranes.I do not have severe liver problems like cirrhosis or jaundice.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (belantamab mafodotin, pomalidomide, dexamethasone)
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 any current opportunities for recruitment into this trial?
"All evidence from clinicaltrials.gov points to this medical trial's ongoing search for suitable patients, which began on July 21st 2022 and was most recently amended on the same date."
Answered by AI
How many individuals have registered to partake in this experiment?
"Affirmative. Details on clinicaltrials.gov demonstrate that this medical experiment, which was first announced on July 21st 2022, is actively recruiting volunteers. Approximately 34 participants must be enrolled from a single research site."
Answered by AI
What potential side effects could be experienced from Belantamab Mafodotin?
"Taking into account the fact that Belantamab Mafodotin is being tested in Phase 2 trials, our team at Power gives it a safety rating of a 2 as there is evidence to suggest its safety but no data supporting its efficacy."
Answered by AI
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