BridgeMD
New treatment option for Multiple Myeloma
Official title Plan Development for Giving Teclistamab in the Outpatient Setting
ClinicalTrials.gov ID: NCT06251076
What this study is testing
What is Teclistamab?
Teclistamab is an investigational medicine, being studied as a potential treatment for multiple myeloma.
Also referred to as TECVAYLI.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a pilot study to develop an outpatient-based process for the administration of teclistamab for for relapsed/refractory multiple myeloma patients and to evaluate the burden on caregivers of patients receiving outpatient administration of teclistamab.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Multiple Myeloma Patients to Receive Outpatient Teclistamab (Part 1):
- Eligible for teclistamab treatment as per Health Canada approved indication:
- Age 18 and greater
- Relapsed or refractory multiple myeloma
- Received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
You likely can't join if
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- Prior or concurrent exposure to any of the following:
- Teclistamab or any anti-BCMA therapy
- Other myeloma therapy (standard of care or investigational) including corticosteroids, within 3 days of first step-up dose of teclistamab
- Toxicities from previous anticancer therapies that have not resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral...
- High risk disease features including:
See the full eligibility criteria
Who can join
- Multiple Myeloma Patients to Receive Outpatient Teclistamab (Part 1):
- Eligible for teclistamab treatment as per Health Canada approved indication:
- Age 18 and greater
- Relapsed or refractory multiple myeloma
- Received at least 3 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody
- Demonstrated disease progression on the last therapy
- For Cohorts 1 and 2, participants must agree to receive treatment at Princess Margaret Cancer Centre. For Cohort 3, participants must agree to receive treatment at Stronach Regional Cancer Centre.
- Must sign the informed consent form (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for the study and is willing to participate...
- Have one or more caregivers meeting study criteria.
- Have clinical laboratory values meeting study criteria.
- Rockwood Clinical Frailty Scale - threshold score ≤ 5
- A woman of childbearing potential must have a negative highly-sensitive serum pregnancy test at screening and must agree to:
- Practicing true abstinence; or
- Have a sole partner who is vasectomized; or
- Practicing ≥1 highly-effective, user-independent method of contraception.
- A woman must agree not to donate eggs (ova, oocytes) or freeze for future use, for the purposes of assisted reproduction during the study. Upon study end, female participants must agree to continue with product...
- A man must wear a condom (with or without spermicidal foam/gel/film/cream/suppository) when engaging in any activity that allows for passage of ejaculate to another person during the study, and thereafter to continue...
- A male participant must agree not to donate sperm for the purpose of reproduction during the study, and thereafter to follow product monograph guidelines with ongoing teclistamab off-study.
What rules you out
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- Prior or concurrent exposure to any of the following:
- Teclistamab or any anti-BCMA therapy
- Other myeloma therapy (standard of care or investigational) including corticosteroids, within 3 days of first step-up dose of teclistamab
- Toxicities from previous anticancer therapies that have not resolved to baseline 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: e. Light chain amyloidosis f. Second malignancy requiring active therapy, exceptions including prostate cancer receiving androgen deprivation therapy or adequately treated breast cancer...
- 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 randomization
- 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
- Major surgery within 2 weeks prior to the start of administration of study treatment (kyphoplasty or vertebroplasty are not considered major surgery).
- 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...
- 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...
- Any other issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the...
- History of non-compliance with recommended medical treatments Caregivers of multiple myeloma people treated with outpatient-based teclistamab (Part 2): Inclusion Criteria:
- Agree to be a caregiver for a participant with multiple myeloma enrolled in this study protocol to receive outpatient teclistamab (any of Cohorts 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...
- 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...
- 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 Criteria:
- Not sufficiently comfortable or understanding of the use of vital sign equipment, applying the ICE score, or other caregiver requirements, as per Investigator discretion
- Unable to complete caregiver follow-up assessments at 30 and 90 days after last treatment subject dose.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.