Multiple Myeloma Clinical Trial
Belantamab Mafodotin and Lenalidomide for the Treatment of Multiple Myeloma in Patients With Minimal Residual Disease Positive After Stem Cell Transplant
This phase II trial investigates the effect of belantamab mafodotin and lenalidomide on minimal residual disease negative rates in patients with multiple myeloma with minimal residual disease positive after stem cell transplant. Belantamab mafodotin is a monoclonal antibody, called belantamab, linked to a chemotherapy drug, called mafodotin. Belantamab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as B-cell maturation antigen (BCMA) receptors, and delivers mafodotin to kill them. Lenalidomide may help block the formation of growths that may become cancer, and is used as a standard of care treatment for multiple myeloma. Giving belantamab mafodotin and lenalidomide may help to maintain minimal residual disease negativity in patients with multiple myeloma.
I. Assess the minimal residual disease (MRD) negative rate at the end (after 12 months) of consolidation with belantamab mafodotin in combination with lenalidomide post autologous stem cell transplantation.
I. Assess sustained MRD negative rate, progression free survival (PFS) and overall survival (OS).
Patients receive belantamab mafodotin intravenously (IV) over 30 minutes on day 1 and lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats every 8 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 12 weeks and the periodically for up to 5 years.
Age >= 18 years of age at time of consent
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Histologically or cytologically confirmed diagnosis of multiple myeloma (MM) as defined according to International Myeloma Working Group (IMWG), 2016 criteria, and
Patient is considered transplant eligible, and
Is not MRD negative complete response (CR) after high dose chemotherapy
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L (within 14 days of first dose of study treatment)
Hemoglobin >= 8.0 g/dL (within 14 days of first dose of study treatment)
Platelets >= 75 X 10^9/L (within 14 days of first dose of study treatment)
Total bilirubin =< 1.5 X upper limit of normal (ULN) (isolated bilirubin >= 1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%) (within 14 days of first dose of study treatment)
Alanine aminotransferase (ALT) =< 2.5 X ULN or < 5 times ULN if documented liver infiltration (within 14 days of first dose of study treatment)
Estimated glomerular filtration rate (eGFR) >= 30 mL/min/ 1.73 m^2 (within 14 days of first dose of study treatment)
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) (within 14 days of first dose of study treatment)
A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Not a woman of childbearing potential (WOCBP) OR
A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period
Female participants of childbearing potential are to have a negative serum pregnancy test within 72 hours before the first dose of study intervention
A male participant must agree to use an adequate method of contraception (as described below) during the treatment period and for at least 6 months after the last dose of study treatment to allow for clearance of any altered sperm, along with the following:
Refrain from donating sperm PLUS either:
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 contraception/barrier
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 enrolment except for alopecia
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Evidence of active bleeding requiring intervention within the last four weeks prior to first dose of study treatment
Current corneal epithelial disease except mild changes in corneal epithelium
Any major surgery within the last four weeks of first dose of study treatment
Use of contact lenses while participating in this study
Participant must not have had plasmapheresis within 7 days prior to first dose of study treatment
Presence of active renal condition (infection, requirement for dialysis or any other condition that could affect patient's safety). Patients with isolated proteinuria resulting from MM are eligible
Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions (including lab abnormalities) that could interfere with patient's safety or compliance to the study procedures
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 patient otherwise meets entry criteria
Malignancies other than disease under study, unless the second malignancy has been medically stable for at least 2 years and, in the opinion of the principal investigators, will not affect the evaluation of the effects of clinical trial treatments on the currently targeted malignancy. Participants with curatively treated non-melanoma skin cancer may be enrolled without a 2-year restriction
Evidence of cardiovascular risk including any of the following:
Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant electrocardiography (EKG) abnormalities such as 2nd degree (type II) or 3rd degree atrioventricular (AV) block.
History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within two months of first dose.
Class III or IV heart failure as defined by the New York Heart Association functional classification system.
Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to belantamab mafodotin or lenalidomide
Active infection requiring antibiotic, antiviral, or antifungal treatment
Known human immunodeficiency virus (HIV) infection
Presence of hepatitis B surface antigen (HBsAg), at or within 3 months of registration Note: If Hepatitis B core antibody (HBcAb) present, see additional monitoring recommendations
Positive hepatitis C antibody test result or positive hepatitis C ribonucleic acid (RNA) test result at or within 3 months prior registration. Note: Patients with positive hepatitis C antibody due to prior resolved disease can be eligible, only if a confirmatory negative hepatitis C RNA test is obtained.
Note: Hepatitis RNA testing is optional and patients with negative hepatitis C antibody test are not required to also undergo hepatitis C RNA testing
Best corrected visual acuity in the worst seeing eye worse than 20/100 (Snellen equivalent). Participants with vision worse than 20/100 due to a treatable condition (e.g., cataract) may be considered on an individual case basis within 6 months before registration
Use of an investigational drug within 14 days of first dose of study treatment or five half-lives, whichever is shorter, preceding the first dose of study drug. Prior treatment with a monoclonal antibody within 30 days of first dose of study treatment
Previously progressed on treatment with belantamab mafodotin
Pregnant or lactating female participants
Unwilling or unable to follow protocol requirements
Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Buffalo New York, 14263, United States More Info
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.