Multiple MyelomaPhase 4NCT06251076
Plan Development for Giving Teclistamab in the Outpatient Setting
A Phase 4 study testing Teclistamab and Tocilizumab in people with Multiple Myeloma and Relapsed Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Relapsed Cancer, Refractory Cancer
- What is being tested?
- Teclistamab and Tocilizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2024to Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.
- 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 monograph guidelines with ongoing teclistamab off-study.
- 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 with product monograph guidelines. If a female partner is of childbearing potential, she must also be practicing a highly effective method of contraception.
- 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.
- 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 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)
Who cannot join
- 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:
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- 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:
- 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.
- 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.
- 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 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, 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 site, to understand informed consent 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 protocol-specified assessments
- History of non-compliance with recommended medical treatments
- Caregivers of multiple myeloma subjects treated with outpatient-based teclistamab (Part 2):
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
About this study
Official title: Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed/Refractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden
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.
- Conditions
- Multiple Myeloma, Relapsed Cancer, Refractory Cancer
- Being tested
- Teclistamab, Tocilizumab
- Medical subject headings
- Multiple Myeloma, Recurrence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeclistamabDrug
Also called TECVAYLI
Teclistamab is an antibody therapy (bispecific T-cell engager [BiTE]) that binds to two target proteins on different cells; CD3 on healthy T cells and B cell maturation antigen (BCMA) on myeloma cells. This brings healthy T cells and the myeloma cells close together so the T cells can more effectively kill them. Teclistamab is approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
TocilizumabDrug
Also called ACTEMRA
Toclilzumab is an interleukin inhibitor approved for the treatment of patients with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) and other indications.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Give teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph. Receives: Drug: Teclistamab |
| Cohort 2 | Experimental | Give teclistamab step-up dosing at Princess Margaret Cancer Centre with the addition of one dose of prophylactic tocilizumab prior to step-up dose 1. Receives: Drug: Teclistamab; Drug: Tocilizumab |
| Cohort 3 | Experimental | Give teclistamab step-up dosing at Southlake Regional Cancer Centre in the outpatient setting using the best method(s) as determined from Cohorts 1 and 2. Receives: Drug: Teclistamab; Drug: Tocilizumab |
| Caregiver Cohort | No intervention | Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median of day hospital encounters or hospitalizations as assessed by using descriptive statistics.
Used to guide development of written processes and protocols for teclistamab outpatient management.
Measured: 1 year
Median incidence of toxicities that are related to underlying disease, disease-related or background regimen as assessed by CTCAE v5.0.
Used to guide development of written processes and protocols for teclistamab outpatient management.
Measured: 1 year
Secondary outcomes (1)
Median for Caregiver Quality of Life Index-Care (CQOLC) scale. Minimum value is 0, maximum value is 140. Lower score means worse outcome.
Used to assess caregiver burden.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start19 Nov 2024
- Primary completion15 Jun 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Sponsor
- Investigators
- Christine Chen, Dr., Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251076
- Sponsor's protocol ID
- Outpatient TEC
- Other IDs
- CAPCR 23-5935, 64007957MMY4009
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient-based Teclistamab Step-up Dosing in Patients With Relapsed/Refractory Multiple Myeloma: Process Development in Academic and Community Centres, and Evaluating Impact on Caregiver Burden
- ClinicalTrials.gov ID
- NCT06251076
- Acronym / sponsor ID
- Outpatient TEC
- Conditions
- Multiple Myeloma, Relapsed Cancer, Refractory Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TeclistamabGive teclistamab step-up dosing at Princess Margaret Cancer Centre as per product monograph. |
| Cohort 2 | Experimental | Drug: Teclistamab, Drug: TocilizumabGive teclistamab step-up dosing at Princess Margaret Cancer Centre with the addition of one dose of prophylactic tocilizumab prior to step-up dose 1. |
| Cohort 3 | Experimental | Drug: Teclistamab, Drug: TocilizumabGive teclistamab step-up dosing at Southlake Regional Cancer Centre in the outpatient setting using the best method(s) as determined from Cohorts 1 and 2. |
| Caregiver Cohort | No intervention | –Caregivers of participants in Cohorts 1, 2, and 3 will complete various questionnaires to assess impact. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Eligible for teclistamab treatment as per Health Canada approved indication:
- 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 in the study. Consent is to be obtained prior to the initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.
- Have one or more caregivers meeting study criteria.
- Have clinical laboratory values meeting study criteria.
Key exclusion criteria (32 listed)
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to any study drug or its excipients.
- Prior or concurrent exposure to any of the following:
- 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:
- Concurrent disorders, including:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeclistamabAlso: TECVAYLITeclistamab is an antibody therapy (bispecific T-cell engager [BiTE]) that binds to two target proteins on different cells; CD3 on healthy T cells and B cell maturation antigen (BCMA) on myeloma cells. This brings healthy T cells and the myeloma cells close together so the T cells can more effectively kill them. Teclistamab is approved for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. | Drug | Cohort 1, Cohort 2, Cohort 3 |
| TocilizumabAlso: ACTEMRAToclilzumab is an interleukin inhibitor approved for the treatment of patients with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) and other indications. | Drug | Cohort 2, Cohort 3 |
Primary outcome
Median of day hospital encounters or hospitalizations as assessed by using descriptive statistics.
Time frame: 1 year
Used to guide development of written processes and protocols for teclistamab outpatient management.
Median incidence of toxicities that are related to underlying disease, disease-related or background regimen as assessed by CTCAE v5.0.
Time frame: 1 year
Used to guide development of written processes and protocols for teclistamab outpatient management.
1 secondary outcome
Median for Caregiver Quality of Life Index-Care (CQOLC) scale. Minimum value is 0, maximum value is 140. Lower score means worse outcome.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Chen, Dr. principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Teclistamab and Tocilizumab in people with Multiple Myeloma and Relapsed Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Chen, Dr. (416-946-2827, Christine.Chen@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median of day hospital encounters or hospitalizations as assessed by using descriptive statistics. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.