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

Recruiting now · Phase 2

Conditions studied: Refractory Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT06421675

Run by

Ontario Clinical Oncology Group (OCOG)

People needed

40

Starts

2025-03-28

Expected to finish

2028-12-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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).

Where it is running

• Vancouver Cancer Center — Vancouver, British Columbia, Canada (enrolling)
• Juravinski Cancer Center — Hamilton, Ontario, Canada (enrolling)
• Kingston General Hospital — Kingston, Ontario, Canada (enrolling)
• London Health Science Centre - Victoria Hospital — London, Ontario, Canada (enrolling)
• London Health Science Centre - Victoria Hospital — London, Ontario, Canada (enrolling)
• Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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