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

NCT06421675 | Recruiting Phase 2 DMC

• 1 other identifier: OCOG-2023-EMBRACE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief 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. 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

Refractory Multiple Myeloma

Keywords

relapsed; refractory; multiple myeloma; elranatamab; cytokine release syndrome; immune effector-cell associated neurotoxicity

Outcome Measures

Primary Outcomes (2)

• 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.

  2 weeks

• 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.

  24 months

Secondary Outcomes (10)

• Overall response rate.

  36 months

• Progression free survival.

  36 months

• Duration of response.

  36 months

• Time to response.

  36 months

• Adverse Events

  36 months

Other Outcomes (3)

• Exploratory outcome BCMA expression (biologic tumor characteristics)

  36 months

• Feasibility, adherence and satisfaction of remote patient monitoring

  First 9 days of treatment.

• Patient satisfaction with the use of the remote monitoring device

  First 9 days of treatment.

Study Arms (1)

Elranatamab injection

EXPERIMENTAL

The 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.

Drug: Elranatamab injection

Interventions

Elranatamab injection DRUG

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

Also known as: Elrexio

Elranatamab injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• Pfizer: collaborator
• McMaster University: collaborator

Study Sites (5)

Vancouver Cancer Center

Vancouver, British Columbia, V5Z 1L3, Canada

RECRUITING

Juravinski Cancer Center

Hamilton, Ontario, L8V 1C3, Canada

RECRUITING

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

London Health Science Centre - Victoria Hospital

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Recurrence; Cytokine Release Syndrome

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Systemic Inflammatory Response Syndrome; Inflammation; Shock

Study Officials

• Hira Mian, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Jim Wright, MD

  OCOG - McMaster University

  STUDY DIRECTOR

Central Study Contacts

Emilio Aguirre, CRA,HIT,CHIM

CONTACT

905-527-2299; aguirre@mcmaster.ca

Daryl Solomon

CONTACT

905-527-2299; solomd5@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: May 20, 2024
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)