Alternate Doses and Dosing Schedules of Belantamab Mafodotin for Treatment of Triple-Class Refractory Multiple Myeloma
- Conditions
- Recurrent Multiple MyelomaRefractory Multiple Myeloma
- Registration Number
- NCT05847569
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria:<br><br> - Age >= 18 years<br><br> - Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2<br><br> - Histologically or cytologically confirmed diagnosis of multiple myeloma (MM), as<br> defined in International Myeloma Working Group (IMWG) criteria, and:<br><br> - If patients have undergone stem cell transplantation (SCT), day 0 of SCT must<br> be > 100 days prior to registration to be eligible for the study<br><br> - Has had disease progression after >= 3 prior lines of anti-myeloma<br> treatments including one proteasome inhibitor (eg. bortezomib, carfilzomib or<br> ixazomib), one immunomodulatory agent (eg.thalidomide, lenalidomide or<br> pomalidomide) and one anti-CD38 monoclonal antibody (eg.daratumumab or<br> isatuximab)<br><br> - Prior non-belantamab mafodotin anti-BCMA agent exposure is allowed; patients<br> with prior treatment with an anti-BCMA chimeric antigen receptor (CAR)-T or<br> bispecific antibody will be allowed to participate in the study<br><br> - Has measurable disease with at least one of the following:<br><br> - Serum M-protein >= 0.5 g/dL (>= 5 g/L)<br><br> - Urine M-protein >= 200 mg/24 h<br><br> - Serum free light chain (FLC) assay: Involved FLC level >= 10 mg/dL (>=<br> 100 mg/L) and an abnormal serum free light chain ratio (< 0.26 or > 1.65)<br><br> - Note: Patients with non-secretory disease will be allowed to participate<br><br> - Absolute neutrophil count >= 0.75 x 10^9/L (=< 28 days prior to registration)<br><br> - Without growth factor support, blood transfusion, or platelet stimulating<br> agents for the past 14 days, excluding erythropoietin<br><br> - Hemoglobin >= 7.0 g/dL (=< 28 days prior to registration)<br><br> - Without growth factor support, blood transfusion, or platelet stimulating<br> agents for the past 14 days, excluding erythropoietin<br><br> - Platelets >= 50 x 10^9/L (=< 28 days prior to registration)<br><br> - Without growth factor support, blood transfusion, or platelet stimulating<br> agents for the past 14 days, excluding erythropoietin<br><br> - Total bilirubin =< 2.0 x upper limit of normal (ULN) (=< 28 days prior to<br> registration); (Isolated bilirubin >= 2.0 x ULN is acceptable if bilirubin is<br> fractionated and direct bilirubin is < 35%)<br><br> - Alanine aminotransferase =< 2.5 x ULN (=< 28 days prior to registration)<br><br> - Aspartate transaminase =< 2.5 x ULN (=< 28 days prior to registration)<br><br> - Estimated glomerular filtration rate (eGFR) >= 30 mL/min/1.73 m^2 (=< 28 days<br> prior to registration)<br><br> - As calculated by Modification of Diet in Renal Disease (MDRD) formula<br><br> - Spot urine (albumin/creatinine ratios [spot urine]) =< 500 mg/g (56 mg/mmol) OR<br> urine dipstick negative/trace (if >1+ only eligible if confirmed =< 500 mg/g<br> [56 mg/mmol] by albumin/creatinine ratio [spot urine from first void]) (=< 28<br> days prior to registration)<br><br> - Negative pregnancy test done =< 7 days prior to registration, for persons of<br> childbearing potential only. Both females and males must agree to follow the<br> instructions<br><br> - NOTE: If the urine test is positive or cannot be confirmed as negative, a serum<br> pregnancy test will be required<br><br> - Provide written informed consent which includes compliance with the requirements and<br> restrictions listed in the informed consent form (ICF) and in the study protocol<br><br> - Willingness to provide mandatory blood specimens for correlative research<br><br> - Willing to return to enrolling institution for follow-up (during the Active<br> Monitoring Phase of the study)<br><br>Exclusion Criteria:<br><br> - Active plasma cell leukemia at the time of screening. Symptomatic amyloidosis,<br> active POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal<br> plasmaproliferative disorder, myeloma protein, and skin changes), Waldenstrom<br> Macroglobulinemia<br><br> - The only exception is emergency use of a short course of systemic corticosteroids<br> (equivalent to, or less than: dexamethasone 40 mg/day for a maximum of 4 days)<br> before treatment<br><br> - Prior belantamab mafodotin therapy. However, patients with prior exposure to another<br> non-belantamab mafodotin anti-BCMA agent such as an anti-BCMA CAR-T or anti-BCMA<br> bispecific antibody will be allowed to participate in the study<br><br> - Systemic active infection requiring treatment<br><br> - Any unresolved toxicity >= grade 2 from previous treatment except for alopecia,<br> or peripheral neuropathy up to grade 2<br><br> - Any major surgery =< 4 weeks prior to registration<br><br> - Any serious and/or unstable pre-existing medical, psychiatric disorder or other<br> conditions (including lab abnormalities except renal impairment) that could<br> interfere with participant's safety, obtaining informed consent or compliance to the<br> study procedures<br><br> - Evidence of active mucosal or internal bleeding<br><br> - Current unstable liver or biliary disease per investigator assessment defined by the<br> presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or<br> gastric varices, persistent jaundice, or cirrhosis. Note: Stable chronic liver<br> disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary<br> involvement of malignancy is acceptable if participant otherwise meets entry<br> criteria<br><br> - Participants with previous or concurrent malignancies other than multiple myeloma<br> are excluded, unless the prior malignancy has been considered medically stable for<br> > 2 years. The participant must not be receiving active therapy, other than<br> hormonal therapy for this disease. NOTE: Participants with curatively treated<br> nonmelanoma skin cancer are allowed without a 2-year restriction.<br><br> - Evidence of cardiovascular risk, including any of the following:<br><br> - Evidence of current clinically significant untreated arrhythmias, including<br> clinically significant electrocardiogram (ECG) abnormalities including 2nd<br> degree (Mobitz type II) or 3rd degree atrioventricular (AV) block<br><br> - History of myocardial infarction (=< 6 months), acute coronary syndromes<br> (including unstable angina), coronary angioplasty, or stenting or bypass<br> grafting within 12 weeks of screening<br><br> - Class III or IV heart failure as defined by the New York Heart Association<br> functional classification system [NYHA, 1994]<br><br> - Uncontrolled hypertension<br><br> - Known immediate or delayed hypersensitivity reaction or idiosyncratic reaction to<br> drugs chemically related to belantamab mafodotin, or any of the components of the<br> study treatment<br><br> - Known human immunodeficiency virus (HIV) infection, unless the participant can meet<br> all of the following criteria:<br><br> - Established anti-retroviral therapy (ART) for at >=4 weeks and HIV viral<br> load < 400 copies/mL<br><br> - CD4+ T-cell (CD4+) counts >= 350 cells/uL<br><br> - No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic<br> infections < 12 months prior<br><br> - Note: consideration must be given to ART and prophylactic antimicrobials that<br> may have a drug-drug inter
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Grade 3/4 keratopathy-free rate
- Secondary Outcome Measures
Name Time Method Overall response rate;Incidence of adverse events (AEs);Time to progression;Progression free survival (PFS);Overall survival (OS);Minimal residual disease (MRD) negativity rate