Comparing 3 approaches for multiple myeloma

Exclusion

• −Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
• −Not sufficiently comfortable or understanding of the use of vital sign equipment, applying the ICE score, or other caregiver requirements, as per InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → discretion
• −e. Light chain amyloidosis f. Second malignancy requiring active therapy, exceptions including prostate cancer receiving androgen deprivation therapy or adequately treated breast cancer carcinoma on anti-hormonal agents and considered to have a very low risk of recurrence g. Underlying neurologic dysfunction (history of seizure, Cerebrovascular Accident (CVA) or Transient ischemic attack (TIA), intracranial hemorrhage, dementia or other cognitive impairment) h. Hepatitis B infection (HBV-DNA positive). Patients with HepBsAg (Surface antigen of Hepatitis B virus) or HepBcAb (Hepatitis B viral protein) positive are allowed on study, only if on antiviral prophylaxis and HBV-DNA viral load is undetectable.
• −Prior or concurrent exposure to any of the following:
• −Teclistamab or any anti-BCMA therapy
• −Other myeloma therapy (standard of careStandard of careThe treatment normally given for a condition outside a study.Read more → or investigational) including corticosteroids, within 3 days of first step-up dose of teclistamab
• −Toxicities from previous anticancer therapies that have not resolved to baselineBaselineYour starting measurements, taken before treatment begins.Read more → levels or to Grade 1 or less except for alopecia or peripheral neuropathy
• −High risk disease features including:
• −Central nervous system (CNS) involvement with myeloma
• −Extramedullary disease (≥1 soft tissue plasmacytoma not associated with bone)
• −Circulating plasma cells (plasma cell leukemia)
• −Rapidly progressive disease, as per investigator assessment
• −Concurrent disorders, including:
• −i. Active infection requiring anti-infective therapy (prophylactic antibiotics are allowed). Cytomegalovirus (CMV) IgG (Immunoglobulin G) positivity allowed, but must be CMV PCR (Polymerase Chain Reaction) negative.
• −j. Underlying coagulopathy that may increase the risk of bleeding in the setting of cytopenia.
• −Presence of the following cardiac conditions:
• −New York Heart Association stage III or IV congestive heart failure
• −Myocardial infarction or coronary artery bypass graft ≤6 months prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
• −History of severe non-ischemic cardiomyopathy
• −Concurrent medical or psychiatric condition or disease that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study, such as:
• −Uncontrolled diabetes
• −Acute diffuse infiltrative pulmonary disease
• −Evidence of active systemic viral, fungal, or bacterial infection, requiring systemic antimicrobial therapy
• −History of autoimmune disease with the exception of vitiligo, type I diabetes, and prior autoimmune thyroiditis that is currently euthyroid based on clinical symptoms and laboratory testing
• −Disabling psychiatric conditions (e.g., alcohol or drug abuse), severe dementia, or altered mental status
• −Other comorbidities felt by treating physician to require hospitalization for teclistamab step-up dosing, such as poorly controlled pain despite use of narcotics, multiple concurrent comorbidities (diabetes, advanced age, cardiac disease)
• −Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational siteTrial siteA hospital or clinic where a study is actually run.Read more →, to understand informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocolProtocolThe detailed plan a study must follow.Read more →-specified assessments
• −History of non-compliance with recommended medical treatments
• −Caregivers of multiple myeloma subjects treated with outpatient-based teclistamab (Part 2):
• −Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →:
• −Agree to be a caregiver for a participant with multiple myeloma enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in this study protocol to receive outpatient teclistamab (any of CohortsCohortA group of participants sharing a characteristic, followed together.Read more → 1, 2, 3)
• −Age 18 and greater
• −English-speaking
• −Must sign an Informed consent form
• −Attend mandatory orientation, equipment training, and provide transportation by car to and from Princess Margaret Cancer Centre until two days after completion of first three doses (at minimum 8 days to encompass step up dosing), and twice weekly to Day 27
• −Accompany the participant through the night and during the day, with no more than 2-hour gaps during the day during which the patient is alone, to end of study (Day 27 or completion of 6 total doses \[2 step up doses + 4 full doses\], whichever is later). More than one caregiver may participate to fill the required hours of accompaniment.
• −Agree to help administer home medications, buy groceries, prepare food and otherwise support the participant
• −Agree and capable of monitoring the participants vital signs, apply the Immune Effector Cell Encephalopathy (ICE) score, record findings, and report to the study team (by phone or in person)
• −Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →:
• −Unable to complete caregiver follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → assessments at 30 and 90 days after last treatment subject dose.
• −Major surgery within 2 weeks prior to the start of administration of study treatment (kyphoplasty or vertebroplasty are not considered major surgery).