Phase 4 Myeloma Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For patients with multiple myeloma (Part 1):

• Adults aged 18 or older who have been diagnosed with multiple myeloma that has come back or stopped responding to treatment, and whose cancer has worsened on the most recent treatment — where the treating doctor determines the person meets the Health Canada-approved criteria for teclistamab
• People who have already received at least 3 different types of myeloma treatment, including specific drug types known as a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody treatment
• People assigned to Cohorts 1 or 2 must agree to receive treatment at Princess Margaret Cancer Centre; people in Cohort 3 must agree to receive treatment at Stronach Regional Cancer Centre
• People who are willing and able to sign a consent form before any study-related procedures begin
• People who have at least one caregiver who also meets the study's caregiver requirements
• People whose recent blood and laboratory test results meet the study's required values (confirm with trial site)
• People who score 5 or below on a standard frailty assessment scale called the Rockwood Clinical Frailty Scale
• Women who could become pregnant must have a negative pregnancy blood test at the start of the study, and must agree to use a reliable method of contraception — such as complete abstinence, having a partner who has had a vasectomy, or at least one highly effective non-user-dependent contraceptive method
• Women must agree not to donate or freeze eggs for reproductive purposes during the study, and to continue following the medication guidelines after the study ends
• Men must agree to use a condom during any activity that could pass ejaculate to another person throughout the study, and to follow medication guidelines afterward; if their partner can become pregnant, that partner must also use a highly effective contraceptive method
• Men must agree not to donate sperm for reproduction during the study, and to follow medication guidelines afterward

For caregivers (Part 2):

• Adults aged 18 or older who agree to act as a caregiver for a patient enrolled in this study
• English-speaking individuals
• People willing to sign a consent form
• People who are able to attend a mandatory orientation and equipment training session, and who can provide car transport to and from Princess Margaret Cancer Centre at the required times during the step-up dosing period and twice weekly until Day 27
• People who can stay with and accompany the patient through the night and during the day — with no more than 2-hour gaps during the day when the patient is alone — from the start of treatment through to Day 27 or the completion of 6 total doses, whichever is later (more than one caregiver may share this responsibility)
• People who agree to help with tasks such as giving the patient their home medications, buying groceries, preparing food, and providing general support
• People who agree to, and are capable of, monitoring the patient's vital signs, applying a standard neurological assessment tool called the ICE score, recording findings, and reporting results to the study team by phone or in person

Who may not be able to join:

For patients with multiple myeloma (Part 1):

• People who have a serious allergy, dangerous sensitivity, or intolerance to the study drug or any of its ingredients
• People who have previously received teclistamab or any treatment that targets a protein called BCMA
• People who have received any other myeloma treatment — including steroids — within 3 days before the first step-up dose of teclistamab
• People who still have significant side effects from previous cancer treatments that have not returned to their normal baseline or reduced to a mild level, except for hair loss or mild nerve-related symptoms
• People whose cancer has certain high-risk features, including: myeloma that has spread to the brain or spinal fluid; soft tissue tumours outside the bone (extramedullary disease); cancer cells circulating in the blood (plasma cell leukaemia); or cancer that is progressing very rapidly, as assessed by the treating doctor
• People with certain other medical conditions, including: a protein deposit disease called light chain amyloidosis; a second cancer currently requiring active treatment (with some exceptions for certain prostate or breast cancers — confirm with trial site); a history of neurological conditions such as seizures, stroke, mini-stroke, bleeding in the brain, dementia, or other significant thinking or memory problems; active hepatitis B infection with detectable virus in the blood (people with certain hepatitis B markers may still be eligible if they are on antiviral treatment and the virus is undetectable — confirm with trial site); an active infection currently requiring treatment with antibiotics, antifungals, or antivirals; or a bleeding disorder that may increase the risk of serious bleeding
• People with significant heart problems, including: severe heart failure (New York Heart Association stage III or IV); a heart attack or major heart surgery within the past 6 months; a history of serious irregular heart rhythms or unexplained fainting not thought to be caused by dehydration or a simple fainting response; or a history of severe non-ischemic heart muscle disease
• People who have had major surgery within 2 weeks before starting the study treatment (note: certain spinal procedures such as kyphoplasty or vertebroplasty are not considered major surgery)
• People with other medical or mental health conditions likely to interfere with the study, including: uncontrolled diabetes; a serious lung condition; an active widespread infection requiring treatment; a history of autoimmune disease (with some exceptions — confirm with trial site); serious mental health or substance use conditions, severe dementia, or significantly altered mental state; any other health issues that the treating doctor believes would require hospitalisation during the step-up dosing period; any condition that could affect the person's ability to safely receive treatment or understand the consent process; or a history of not following recommended medical treatment

For caregivers (Part 2):

• People who are not sufficiently comfortable with, or do not adequately understand, the use of vital sign monitoring equipment, the ICE neurological assessment tool, or other caregiver responsibilities, as assessed by the study investigator
• People who are unable to complete follow-up assessments at 30 and 90 days after the patient's last treatment dose

Important: Always verify eligibility with the trial site directly before applying.