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Refractory Multiple MyelomaPhase 2EMBRACENCT06421675

Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma

A Phase 2 study testing Elranatamab injection in people with Refractory Multiple Myeloma, run by Ontario Clinical Oncology Group (OCOG) at 6 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Refractory Multiple Myeloma
What is being tested?
Elranatamab injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
6 sitesCanada
Study dates
28 Mar 2025to Dec 2028
Phase
Phase 2
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

  • Relapsed and/or refractory MM defined as:
  • Documented evidence of progressive disease (PD) after achieving at least minimal response (MR) for ≥ 1 cycle during a previous MM treatment (i.e., relapsed MM).
  • Disease progression during or within 60 days from the end of the most recent MM treatment (i.e., refractory MM).
  • Measurable disease based on IMWG criteria, defined as at least one of the following, documented within 28 days before enrollment:
  • Serum M-protein ≥ 0.5 g/dl.
  • Urine M-protein excretion ≥ 200 mg/24 h.
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  • Serum-free light chains (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/l) AND an abnormal serum-free light chain ratio (< 0.26 or > 1.65) only for patients without measurable serum or urine M protein.
  • Receipt of at least three prior classes of drugs either in separate regimens or as combinations.
  • The three classes are defined as:
  • An immunomodulatory drug (lenalidomide or pomalidomide), a proteasome inhibitor (bortezomib, ixazomib, carfilzomib), and an anti-CD38 drug (daratumumab or isatuximab).
  • At least 18 years of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of ≤2.

Who cannot join

  • Medical conditions
  • Active plasma cell leukemia (either 20% of peripheral white blood cells or > 2.0 × 109/L circulating plasma cells by standard differential).
  • Amyloidosis.
  • POEMS syndrome (Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal plasma cell disorder, Skin Changes).
  • Monoclonal gammopathy of unknown significance or smoldering multiple myeloma.
  • Solitary plasmacytoma.
Show all 43Show fewer
  • Stem cell transplant within 12 weeks prior to enrollment or active graft versus host disease.
  • History of prior treatment with a BCMA targeting agent.
  • Laboratory Parameters
  • Laboratory results within 28 days as per below prior to enrollment:
  • Absolute neutrophil count (ANC) ≤ 1.0 x 109 /L) (use of growth factor is permitted if completed at least 7 days prior to enrollment).
  • Platelet count ≤ 25 x 109 /L (transfusion support permitted if completed at least 7 days prior to enrollment).
  • Hemoglobin ≤ 8.0 g/dL (transfusion support permitted if completed at least 7 days prior to enrollment, concurrent erythropoietin stimulating agents allowed).
  • Serum AST and ALT > 2.5 x upper limit of normal (ULN).
  • Creatinine clearance < 30 mL/min (according to the Cockcroft Gault formula, by 24-hour urine collection for creatinine clearance, or according to local institutional standard method).
  • Total bilirubin > 2.0 x ULN (≥ 3.0 unless known to have Gilbert's disease).
  • Support Requirement
  • As this protocol requires outpatient administration, the patient will be excluded if they cannot agree to the following for the first 9 days post-first dose of drug administration:
  • Staying within 60 minutes of travel distance to their trial-based hospital.
  • Must have a caregiver/support person who will stay with the patient.
  • Patient and/or their caregiver/support person agree to monitor and record oral temperature q8 hours.
  • Patients must agree that if they have an oral temperature of (≥38°C), they must report to the study team within 1 hour and can come to the hospital for admission within 2 hours.
  • Other co-morbidities
  • Impaired cardiovascular function or clinically significant cardiovascular diseases, defined as any of the following within 6 months before enrollment:
  • Acute myocardial infarction or acute coronary syndromes (eg, unstable angina, coronary artery bypass graft, coronary angioplasty or stenting, symptomatic pericardial effusion).
  • Clinically significant cardiac arrhythmias (eg, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia).
  • Thromboembolic or cerebrovascular events (eg, transient ischemic attack, cerebrovascular accident, deep vein thrombosis [unless associated with a central venous access complication], or pulmonary embolism).
  • Prolonged QT syndrome (or triplicate average QTcF >470 msec at screening).
  • Ongoing Grade ≥2 peripheral sensory or motor neuropathy.
  • History of Guillain-Barre Syndrome (GBS) or GBS variants, or history of any Grade ≥3 peripheral motor polyneuropathy.
  • Unresolved acute effects of any prior therapy for MM in the last three months to either baseline severity or NCI CTCAE ≤Grade 1.
  • Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
  • Any other active malignancy within 2 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities), or surgical (major surgery within 14 days prior to enrollment) that could interfere with the patient's safety, obtaining informed consent or compliance to the study procedures.
  • Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to elranatamab or any of the components of the study treatment.
  • Concomitant Medications
  • Treatment with a chemotherapeutic or anti-MM drug within the last 28 days or 5 half-lives (whichever is shorter) prior to enrollment or are currently enrolled in another interventional clinical study.
  • Receipt of any other therapy to treat cancer (including radiation, biologics, cellular therapies, and/or steroids at doses > 20 mg dexamethasone or equivalent) within 14 days prior to the enrollment.
  • Receipt of any live vaccine within 30 days prior to enrollment or expected need of live vaccination during study participation. (Administration of locally approved non-live vaccine can be done as per local guidelines during the screening and/or treatment period including the COVID-19 mRNA vaccine. Elranatamab should be administered ± 7 days from the SARS-CoV-2 vaccine administration).
  • Pregnancy and Contraception
  • Pregnancy or lactating female or inability of female patients of childbearing potential (FCBP) to meet contraception requirements (see Section 5.1.3.).
  • Informed Consent
  • Inability to provide signed, informed consent.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Emilio Aguirre, CRA,HIT,CHIM contact

905-527-2299 ext. 42650

aguirre@mcmaster.ca

Daryl Solomon contact

905-527-2299 ext. 42622

solomd5@mcmaster.ca

6 sites in 1 country

Canada6 sites, 6 recruiting

  • Juravinski Cancer Center

    Hamilton, Ontario, L8V 1C3

    Hira Mian, MD, 905-387-9495, hira.mian@medportal.ca

    Recruiting

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

    Ashlee Young, Trial Activation Coordinator, 613-549-6666, ashlee.young@kingstonhsc.ca

    Bethany Monteith, MD

    Recruiting

  • London Health Science Centre - Victoria Hospital

    London, Ontario, N6A 5W9

    Martha de Lacerda Louzada, MD, 01-519-685-8500, Martha.Louzada@lhsc.on.ca

    Recruiting

  • Ottawa Hospital

    Ottawa, Ontario, K1H 8L6

    Arleigh Robertson McCurdy, MD, 613-737-8899 ext. 71281

    Recruiting

  • Vancouver Cancer Center

    Vancouver, British Columbia, V5Z 1L3

    Christopher Venner, MD, 604-877-6000

    Recruiting

  • Bc Cancer - Victoria

    Victoria, British Columbia, V8R 6V5

    ASHLEY FREEMAN, MD, 01-250-519-5500, ashley.freeman@bccancer.bc.ca

    Recruiting

Other trials in Canada

About this study

Official title: A Study of Elranatamab Management With Outpatient and Intermittent Dosing in Relapsed/Refractory Multiple Myeloma

A phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. The primary objective of this study is to improve the tolerability and safety of elranatamab in patients with relapsed and/or refractory multiple myeloma by evaluating an outpatient and intermittent dosing strategy.

Read the detailed description

This is a multi-centre, single arm, phase II study of single agent elranatamab in patients with relapsed and/or refractory multiple myeloma (MM) who have previously received at least three classes of therapeutic agents and are refractory to the last line of treatment. Potential study participants must have documented evidence of refractory or progressive disease during or within 60 days (measured from the end of the last cycle) of completing treatment with the last anti-myeloma drug regimen used just prior to study entry. Study participants will receive SC administration of elranatamab until disease progression, unacceptable toxicity or death. The primary short term outcome is hospitalization rate within the first 2 weeks of Cycle 1 of treatment; the primary long term outcome is rate of grade 3+ infections within the first 24 months of treatment. Study participants will be followed for survival for 36 months from the date of enrollment. A total of 40 study participants will be enrolled across approximately 5 Canadian clinical trial sites.

Being tested
Elranatamab injection
Keywords
relapsed, refractory, multiple myeloma, elranatamab, cytokine release syndrome, immune effector-cell associated neurotoxicity
Medical subject headings
Multiple Myeloma, Recurrence, Cytokine Release Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elranatamab injectionDrug

    Also called Elrexio

    Elranatamab (Elrexfio) is a humanized bispecific antibody that targets both BCMA-expressing multiple myeloma (MM) cells and CD3-expressing T cells.

Study groups in NCT06421675
Study groupRoleWhat they receive
Elranatamab injectionExperimentalThe administration of two step-up elranatamab doses (12 mg and 32 mg) and full dose 76 mg. The dosing interval for the first Cycle (each cycle q28 days) is every week. Cycles 2-3, the dosing interval increases to q2weeks. Cycles 4-12, the dosing interval increases to q4weeks. Cycles 13+, further dosing interval increases to q8weeks will be scheduled if a participant meets criteria for IMWG complete response (CR) in Cycle 12 (bone marrow required at Cycle 12 to confirm). If a participant does not meet CR criteria at Cycle 12, they will be continued on Q4W dosing.
Receives: Drug: Elranatamab injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization rate

    Hospitalization rate, defined as the number of patients who are hospitalized within the first 2 weeks of Cycle 1 of treatment, due to any cause, divided by the number of patients who are treated with elranatamab.

    Measured: 2 weeks

  2. Rate of grade 3+ infections

    Rate of grade 3+ infections as grade by NCI CTCAE v5 within the first 24 months of treatment, defined as the number of patients who experience a grade 3+ infection within 24 months of treatment, divided by the number of patients who are treated with elranatamab.

    Measured: 24 months

Secondary outcomes (10)

  1. Overall response rate.

    Overall response rate, defined by the IMWG criteria.

    Measured: 36 months

  2. Progression free survival.

    PFS, defined as the time from the date of first dose until confirmed PD per IMWG criteria or death due to any cause, whichever occurs first.

    Measured: 36 months

  3. Duration of response.

    DOR is defined, for participants with an overall response per IMWG criteria, as the time from the first documentation of overall response that is subsequently confirmed, until confirmed PD per IMWG criteria, or death due to any cause, whichever occurs first.

    Measured: 36 months

  4. Time to response.

    TTR is defined, for participants with an overall response per IMWG criteria, as the time from the date of first dose to the first documentation of overall response that is subsequently confirmed.

    Measured: 36 months

  5. Adverse Events

    AEs will be graded according to NCI CTCAE Version 5. CRS and ICANS will be assessed. AEs will be characterized by type, frequency, severity, timing, seriousness, and relationship to elranatamab. AEs will be presented with and without regard to causality based on the investigator's judgment. The frequency of overall toxicity, categorized by toxicity Grades 1 through 5, will be described. Additional summaries will be provided for AEs that are observed with higher frequency and for AESIs (including CRS and ICANS).

    Measured: 36 months

  6. Clinical laboratory data

    Clinical laboratory data will be classified by grade according to NCI CTCAE version 5.0 and will be analyzed using summary statistics. The worst on-treatment grades during the treatment period will be summarized.

    Measured: 36 months.

  7. Overall survival

    OS, defined from the date of study registration to the date or death due to any cause.

    Measured: 36 months

  8. Patient Frailty

    Frailty will be measured using the IMWG frailty score and the time for the 4-meter walk test will be recorded.

    Measured: To the time of disease progression.

  9. Frequency and Timing of Hospitalization

    Frequency and timing hospitalization will be recorded during the first two weeks of the study treatment.

    Measured: 2 weeks.

  10. Patient Quality of Life

    QoL during treatment measured using the EORTC QOL Questionnaire-C30 instrument EORTC QLQ-C30

    Measured: To the time of disease progression.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2024
  2. Study start28 Mar 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Multi-center, single-arm, phase II study of single-agent elranatamab in patients with relapsed and/or refractory multiple myeloma.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06421675
Sponsor's protocol ID
OCOG-2023-EMBRACE
Acronym
EMBRACE
Status last verified
Sep 2026
First submitted
11 Mar 2024
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Elranatamab injection in people with Refractory Multiple Myeloma, run by Ontario Clinical Oncology Group (OCOG) at 6 sites 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 12 inclusion and 43 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 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Emilio Aguirre, CRA,HIT,CHIM (905-527-2299 ext. 42650, aguirre@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization rate (time frame: 2 weeks). 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?

On the ClinicalTrials.gov record for NCT06421675.

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 28 Sep 2026.

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