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

Part of paid clinical trials in Denver, Colorado.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT07637578
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    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.
  • Tocilizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jun 10, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Oct 31, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-in (Cohort 1)
    Participants will receive a single intravenous (IV) dose of tocilizumab prior to the first step-up dose (SUD) of elranatamab. Elranatamab will be administered subcutaneously (SC) each cycle. Cycles will be 28 days. 6 participants will be enrolled into this Lead-In Cohort 1 to evaluate safety of regimen before proceeding to enroll into Expansion cohort.
  • Experimental: Expansion (Cohort 2)
    Participants will receive a single intravenous (IV) dose of tocilizumab prior to the first step-up dose (SUD) of elranatamab. Elranatamab will be administered subcutaneously (SC) each cycle. Cycles will be 28 days. 40 participants will be enrolled into this Expansion Cohort 2.

Primary Outcome Measure

Incidence of Cytokine Release Syndrome (CRS) in Cycle 1 [ Time Frame: From Cycle 1 Day 1 to Cycle 1 Day 28 for all participants. Each cycle is 28 days. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218
Henning Schade, MD (PRINCIPAL_INVESTIGATOR)
Willamette Valley Cancer Institute and Research CenterEugeneOregon97401
Christopher Yasenchak, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Hans Lee, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Denver, CO

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By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Colorado Blood Cancer Institute· Denver, COWillamette Valley Cancer Institute and Research Center· Eugene, ORSCRI Oncology Partners· Nashville, TN

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