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A Study of Elranatamab Outpatient Administration in Patients With Relapsed/Refractory Multiple Myeloma

NCT07637578 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-11

No results posted yet for this study

Summary

This is a Phase II, open-label, nonrandomized, single-arm study of elranatamab that will be administered in the outpatient setting in 2 sequential cohorts of participants with relapsed or refractory multiple myeloma (RRMM). The primary objective of this study is to evaluate the overall incidence of cytokine release syndrome (CRS) during Cycle 1 of elranatamab treatment following a single prophylactic dose of tocilizumab.

Conditions

  • Multiple Myeloma (MM)
  • Multiple Myeloma Refractory
  • Multiple Myeloma in Relapse
  • Multiple Myeloma

Interventions

DRUG

Elranatamab

Elranatamab will be administered subcutaneously (SC) in step-up doses on Day 1 (12 mg) and Day 4 (32 mg) followed by dosing of 76 mg on Day 8, Day 15, and Day 22 during Cycle 1, then 76 mg every other week for Cycle 2 and 3. For Cycles 4- 12, elranatamab 76 mg dose will be given once a cycle. Participants will receive a maximum of 12 cycles of elranatamab. Cycles will be 28 days.

DRUG

Tocilizumab

A single (one time) intravenous (IV) dose of tocilizumab 8 mg/kg will be administered 1-4 hours prior to the first step-up dose (SUD) of elranatamab in Cycle 1. Cycles will be 28 days.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Hans Lee, MD · Sarah Cannon Research Institute (SCRI) Oncology Partners

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-10-31
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07637578 on ClinicalTrials.gov