Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
Phase II Trial for Evaluation of Alternate Doses and Dosing Schedules of Belantamab Mafodotin in Triple-Class Refractory Multiple Myeloma
3 other identifiers
interventional
62
1 country
1
Brief Summary
This phase II trial tests alternate doses and dosing schedules of belantamab mafodotin in treating patients with triple-class multiple myeloma that has come back (after a period of improvement) (recurrent) and/or does not respond to treatment (or that has not responded to previous treatment) (refractory). Belantamab mafodotin is a monoclonal antibody, belantamab, linked to a chemotherapy drug, mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as BCMA receptors, and delivers mafodotin to kill them. This trial may help researchers determine if alternate doses and dosing schedules work better in preventing certain side effects, such as eye toxicity, and treating patients with recurrent or refractory multiple myeloma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2024
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2023
CompletedFirst Posted
Study publicly available on registry
May 6, 2023
CompletedStudy Start
First participant enrolled
January 4, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 29, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 29, 2034
February 3, 2026
January 1, 2026
5.5 years
April 27, 2023
January 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Grade 3/4 keratopathy-free rate
The proportion of successes will be estimated by the number of successes (proportion of patients free of grade 3/4 keratopathy at the time of dose #4) divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. If both arms prove to meet the primary endpoint, they will be evaluated indirectly in relation to each other similar, to a Bayesian pick the winner, approach if only one can be brought forward for further testing
At the time of dose 4
Secondary Outcomes (6)
Overall response rate
Up to 5 years
Incidence of adverse events (AEs)
Up to 5 years
Time to progression
From registration to the earliest date of documentation of disease progression, assessed up to 5 years
Progression free survival (PFS)
From registration to the earliest date of documentation of disease progression or relapse or death due to any cause, assessed up to 5 years
Overall survival (OS)
From registration to death due to any cause, assessed up to 5 years
- +1 more secondary outcomes
Study Arms (2)
Group I (low dose belantamab mafodotin)
ACTIVE COMPARATORPatients receive low dose belantamab mafodotin intravenously (IV) on day 1 of each cycle. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. All patients undergo a CT scan, a MRI scan, or a PET/CT scan during screening and patients with plasmacytoma (a MM tumor in bone or soft tissue) also undergo imaging scans on study. Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial.
Group II (low dose and high dose belantamab mafodotin)
EXPERIMENTALPatients receive belantamab mafodotin IV on day 1. Cycle repeats at 3 weeks for the next cycle and then every 6 weeks for subsequent cycles in the absence of disease progression or unacceptable toxicity. All patients undergo a CT scan, a MRI scan, or a PET/CT scan during screening and patients with plasmacytoma (a MM tumor in bone or soft tissue) also undergo imaging scans on study. Patients undergo bone marrow aspirate and biopsy during screening and on study as well as collection of blood samples throughout the trial.
Interventions
Given IV
Undergo collection of blood samples
Undergo bone marrow aspirate
Undergo biopsy
Undergo CT scan
Undergo MRI scan
Undergo PET/CT scan
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
- Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as defined in International Myeloma Working Group (IMWG) criteria, and:
- If patients have undergone stem cell transplantation (SCT), day 0 of SCT must be \> 100 days prior to registration to be eligible for the study
- Has had disease progression after \>= 3 prior lines of anti-myeloma treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or ixazomib), one immunomodulatory agent (eg.thalidomide, lenalidomide or pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or isatuximab)
- Prior non-belantamab mafodotin anti-BCMA agent exposure is allowed; patients with prior treatment with an anti-BCMA chimeric antigen receptor (CAR)-T or bispecific antibody will be allowed to participate in the study
- Has measurable disease with at least one of the following:
- Serum M-protein \>= 0.5 g/dL (\>= 5 g/L)
- Urine M-protein \>= 200 mg/24 h
- Serum free light chain (FLC) assay: Involved FLC level \>= 10 mg/dL (\>= 100 mg/L) and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65)
- Note: Patients with non-secretory disease will be allowed to participate
- Absolute neutrophil count \>= 0.75 x 10\^9/L (=\< 28 days prior to registration)
- Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
- Hemoglobin \>= 7.0 g/dL (=\< 28 days prior to registration)
- Without growth factor support, blood transfusion, or platelet stimulating agents for the past 14 days, excluding erythropoietin
- +13 more criteria
You may not qualify if:
- Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis, active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom Macroglobulinemia
- Prior belantamab mafodotin therapy. However, patients with prior exposure to another non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA bispecific antibody will be allowed to participate in the study
- Systemic active infection requiring treatment
- Any unresolved toxicity \>= grade 2 from previous treatment except for alopecia, or peripheral neuropathy up to grade 2
- Any major surgery =\< 4 weeks prior to registration
- Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities except renal impairment) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures
- Evidence of active mucosal or internal bleeding
- Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if participant otherwise meets entry criteria
- Participants with previous or concurrent malignancies other than multiple myeloma are excluded, unless the prior malignancy has been considered medically stable for \> 2 years. The participant must not be receiving active therapy, other than hormonal therapy for this disease. NOTE: Participants with curatively treated nonmelanoma skin cancer are allowed without a 2-year restriction.
- Evidence of cardiovascular risk, including any of the following:
- Evidence of current clinically significant untreated arrhythmias, including clinically significant electrocardiogram (ECG) abnormalities including 2nd degree (Mobitz type II) or 3rd degree atrioventricular (AV) block
- History of myocardial infarction (=\< 6 months), acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within 12 weeks of screening
- Class III or IV heart failure as defined by the New York Heart Association functional classification system \[NYHA, 1994\]
- Uncontrolled hypertension
- Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to drugs chemically related to belantamab mafodotin, or any of the components of the study treatment
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo D. Parrondo, M.D.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2023
First Posted
May 6, 2023
Study Start
January 4, 2024
Primary Completion (Estimated)
June 29, 2029
Study Completion (Estimated)
June 29, 2034
Last Updated
February 3, 2026
Record last verified: 2026-01