Phase II Trial for Evaluation of Alternate Doses and Dosing Schedules of Belantamab Mafodotin in Triple-Class Refractory Multiple Myeloma

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Platelets \>= 50 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

• Total bilirubin =\< 2.0 x upper limit of normal (ULN) (=\< 28 days prior to registration); (total bilirubin \>= 2.0 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \< 35%)

• Alanine aminotransferase =\< 2.5 x ULN (=\< 28 days prior to registration)

• Aspartate transaminase =\< 2.5 x ULN (=\< 28 days prior to registration)

• Estimated glomerular filtration rate (eGFR) \>= 30 mL/min/1.73 m\^2 (=\< 28 days prior to registration)

‣ As calculated by Modification of Diet in Renal Disease (MDRD) formula

• Spot urine \[albumin/creatinine ratios (spot urine)\] =\< 500 mg/g (56 mg/mmol) OR urine dipstick negative/trace \[if \>1+ only eligible if confirmed =\< 500 mg/g (56 mg/mmol) by albumin/creatinine ratio (spot urine from first void)\] (=\< 28 days prior to registration)

• Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only. Both females and males must agree to follow the instructions

‣ NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

• Provide written informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the study protocol

• Willingness to provide mandatory blood specimens for correlative research

• Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Time Frame
Start Date: 2024-01-04
Estimated Completion Date: 2027-05-29
Participants
Target number of participants: 62
Treatments
Active_comparator: Group I (low dose belantamab mafodotin)
Patients 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.
Experimental: Group II (low dose and high dose belantamab mafodotin)
Patients 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.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov