Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06421675

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

Led by Ontario Clinical Oncology Group (OCOG) · Updated on 2026-04-27

40

Participants Needed

5

Research Sites

192 weeks

Total Duration

On this page

Sponsors

O

Ontario Clinical Oncology Group (OCOG)

Lead Sponsor

P

Pfizer

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older
  • Diagnosed with relapsed and/or refractory multiple myeloma defined by disease progression during or within 60 days of last treatment
  • Measurable disease according to IMWG criteria within 28 days before enrollment
  • Received at least three prior classes of drugs including immunomodulatory drugs, proteasome inhibitors, and anti-CD38 drugs
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less
Not Eligible

You will not qualify if you...

  • Active plasma cell leukemia with ≥20% of peripheral white blood cells or >2.0 × 109/L circulating plasma cells
  • Amyloidosis
  • POEMS syndrome
  • 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
  • Prior treatment with a BCMA targeting agent
  • Laboratory abnormalities within 28 days before enrollment including low neutrophils, low platelets, low hemoglobin, elevated liver enzymes, reduced kidney function, or high bilirubin
  • Unable to stay within 60 minutes of travel to the study hospital for the first 9 days after first dose or without a caregiver to monitor temperature and support
  • Significant heart conditions within 6 months prior to enrollment such as heart attack, serious arrhythmias, thromboembolic events, or prolonged QT syndrome
  • Ongoing Grade 2 or higher peripheral neuropathy or history of Guillain-Barre Syndrome or severe motor polyneuropathy
  • Unresolved effects of prior multiple myeloma therapy in the last 3 months worse than Grade 1
  • Active infections including hepatitis B or C, HIV, SARS-CoV2, or uncontrolled infections
  • Other active cancers within 2 years except certain skin cancers
  • Serious unstable medical or psychiatric conditions or recent major surgery
  • Known allergy to elranatamab or its components
  • Recent cancer treatments or enrollment in another interventional study
  • Recent live vaccinations or planned live vaccinations during the study
  • Pregnancy, lactation, or inability to meet contraception requirements
  • Inability to provide signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Vancouver Cancer Center

Vancouver, British Columbia, Canada, V5Z 1L3

Actively Recruiting

2

Juravinski Cancer Center

Hamilton, Ontario, Canada, L8V 1C3

Actively Recruiting

3

Kingston General Hospital

Kingston, Ontario, Canada, K7L 2V7

Actively Recruiting

4

London Health Science Centre - Victoria Hospital

London, Ontario, Canada, N6A 5W9

Not Yet Recruiting

5

Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

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Research Team

E

Emilio Aguirre, CRA,HIT,CHIM

CONTACT

D

Daryl Solomon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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