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New treatment option for Multiple Myeloma
Official title Study of Belantamab Mafodotin With Carfilzomib, Pomalidomide, and Dexamethasone in Relapsed Multiple Myeloma
ClinicalTrials.gov ID: NCT05789303
What this study is testing
What is Belantamab mafodotin?
Belantamab mafodotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple myeloma.
Also referred to as Blenrep.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Doctors leading this study hope to learn if the combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone is effective and safe when given to people who have multiple myeloma that has gotten worse and is not responding to standard drugs that are used for treating multiple myeloma, including chimeric antigen receptor T-cell therapy. Participation in this research will last about 6 -24 months, but it may be less or more depending on your response to treatment.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must be ≥ 18 years of age.
- Life expectancy of more than three months.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Subject must have adequate organ function, defined by clinically confirmed lab values set by the study team.
- Female people: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in...
You likely can't join if
- Disease Related
- Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.
- Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is...
- Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding...
- Prior refractory status to belantamab mafodotin. Concurrent Conditions
- Current corneal epithelial disease except mild changes in corneal epithelium and mild punctate keratopathy.
See the full eligibility criteria
Who can join
- Subject must be ≥ 18 years of age.
- Life expectancy of more than three months.
- Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Subject must have adequate organ function, defined by clinically confirmed lab values set by the study team.
- Female people: contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male people: contraceptive should be used consistently with local regulations regarding the methods of contraception for those people in clinical studies. Male people are eligible to participate if they agree to the...
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
- Must agree to use a male condom, even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having...
- 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 enrollment except for alopecia and...
- Subject must be able to understand the study procedures and agree to participate in the study by providing written informed consent.
- Subject must be willing to comply with the requirements consistent with the belantamab mafodotin and pomalidomide Risk Evaluation and Mitigation Strategy (REMS) programs. DISEASE-RELATED:
- people with relapsed or refractory multiple myeloma requiring systemic therapy, who have progressed after 2+ prior lines of anti-myeloma treatments. A line of therapy consists of ≥1 complete cycle of a single agent, a...
- people may be exposed to lenalidomide, bortezomib, daratumumab, elotuzumab, pomalidomide and/or carfilzomib.
- If NO prior CAR T-cell therapy: people who have been deemed refractory to EITHER carfilzomib or pomalidomide are permitted but people cannot be refractory to both carfilzomib and pomalidomide. Refractoriness is defined...
- If prior CAR T-cell therapy: people whose most recent line of therapy was anti-B-cell maturation antigen (BCMA) targeted CAR T-cell therapy are permitted to enroll, regardless of carfilzomib/pomalidomide refractory...
- Measurable disease, as indicated by one or more of the following:
- Serum M-protein of 0.5 g/dL of greater. If serum protein electrophoresis is felt to be unreliable for routine M-protein measurement (i.e. M-spike in the beta region), then quantitative immunoglobulin levels are...
- Urine M-protein ≥ 200 mg/24 hours.
- Involved serum free light chains ≥ 10 mg/dL provided that free light chain ratio is abnormal.
- people must receive insurance approval for pomalidomide and dexamethasone.
What rules you out
- Disease Related
- Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia at the time of screening.
- Radiotherapy to multiple sites within 3 weeks before start of protocol treatment (localized radiotherapy to a single site 1 week before start is permissible).
- Subject must not have used an investigational drug or approved systemic anti-myeloma therapy (including systemic steroids) within 14 days preceding the first dose of study drug.
- Prior refractory status to belantamab mafodotin. Concurrent Conditions
- Current corneal epithelial disease except mild changes in corneal epithelium and mild punctate keratopathy.
- Subject must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note...
- Subject must not have presence of active renal condition (infection, requirement for dialysis or any other condition that could affect Subject's safety). people with isolated proteinuria resulting from multiple myeloma...
- Subject must not use contact lenses while participating in this study unless instructed by an ophthalmologist.
- Subject must not be simultaneously enrolled in any treatment clinical trial.
- Subject must not have had major surgery ≤ 2 weeks prior to initiating study treatment.
- Subject must not have any evidence of active mucosal or internal bleeding.
- Significant neuropathy (Grades 3-4, or Grade 2 with pain) at the time of the first dose and/or within 14 days before enrollment.
- Subject must not have evidence of cardiovascular risk including any of the following:
- Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block. Controlled atrial...
- History of myocardial infarction, acute coronary syndromes, coronary angioplasty, or stenting or bypass grafting within three (3) months of screening.
- Class III or IV heart failure as defined by the New York Heart Association functional classification system
- Uncontrolled hypertension.
- Subject must not have known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study...
- Subject must not have an active infection requiring treatment.
- Subject with HIV infection will be excluded unless certain T-cell count, viral load and clinical qualifications are met as confirmed by the study doctor Note: consideration must be given to anti-retroviral and...
- Patients with Hepatitis B will be excluded unless certain clinical criteria are met as confirmed by the study doctor.
- Subject must not have positive hepatitis C antibody test result or positive hepatitis C Ribonucleic acid test result at screening or within 3 months prior to first dose of study treatment unless the subject can meet the...
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.