Symptoms and General Pathology

All Conditions

Neoplasms

Heart and Blood Diseases

Blood and Lymph Conditions

Immune System Diseases

Nervous System Diseases

Substance Related Disorders

Rare Diseases

Syndrome

Multiple Myeloma

Neoplasms, Plasma Cell

Cytokine Release Syndrome

Neurotoxicity Syndromes

Neoplasms by Histologic Type

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Lymphoproliferative Disorders

Immunoproliferative Disorders

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

The administration of two step-up elranatamab doses (12 mg and 32 mg) and full dose 76 mg. The dosing interval for the first 6 cycles (each cycle q28 days) is every week, cycles 7-12 are bi-weekly. The dosing interval will increase to q4 weeks (cycle 13+) according to IMWG dose-response criteria of \>= VGPR. Further dosing interval increase to q8weeks (cycles 19+) will be done among participants based on response criteria IMWG of \>= CR.

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

Elranatamab injection

Emilio Aguirre, CRA,HIT,CHIM

Sharon Nason

Nazir Jacques Bahlis, MD

Irwindeep Sandhu, MD

Christopher Venner, MD

Hira Mian, MD

Arleigh Robertson McCurdy, MD

Jim Wright, MD

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.

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.

Multi-center, single-arm, phase II study of single-agent elranatamab in patients with relapsed and/or refractory multiple myeloma.

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

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

BCMA levels in blood and their relationship to clinical response and progression.

Feasibility, adherence and satisfaction of remote patient monitoring during the first 9 days of treatment using an outpatient remote monitoring device

Patient satisfaction with the use of the remote monitoring device will be captured using a single, 5-point likert scale question, asked when the device is returned.

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.

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.

Overall response rate, defined by the IMWG criteria.

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.

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.

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.

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).

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.

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma	NCT06421675	Refractory Mult...	Elranatamab inj...	18 Years -	Ontario Clinical Oncology Group (OCOG)
Outpatient and Intermittent Dosing of Elranatamab in Relapsed/Refractory Multiple Myeloma	NCT06421675	Refractory Mult...	Elranatamab inj...	18 Years -	Ontario Clinical Oncology Group (OCOG)

Spots Global Cancer Trial Database for elranatamab injection