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

NCT07637578 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: MM 214
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Multiple Myeloma; MM; RRMM; Relapsed multiple myeloma; Refractory multiple myeloma; Relapsed or refractory multiple myeloma; Elranatamab; Tocilizumab; T-cell engager

Outcome Measures

Primary Outcomes (1)

• Incidence of Cytokine Release Syndrome (CRS) in Cycle 1

  Evaluate the number of participants with events of CRS during Cycle 1 of study treatment. CRS events will be graded per the American Society for Transplantation and Cellular Therapy grading (ASTCT 2019).

  From Cycle 1 Day 1 to Cycle 1 Day 28 for all participants. Each cycle is 28 days.

Secondary Outcomes (13)

• Incidence of ≥ Grade 2 CRS during Cycle 1

  From Cycle 1 Day 1 to Cycle 1 Day 28 for all participants. Each cycle is 28 days.

• Incidence of all-grade CRS

  Every cycle from Cycle 1 Day 1 to 30 days after last dose of elranatamab, up to approximately 13 months (12 cycles, 28-day cycle length plus 30 days of follow-up).

• Incidence of recurrent CRS

  Every cycle from Cycle 1 Day 1 to 30 days after last dose of elranatamab, up to approximately 13 months (12 cycles, 28-day cycle length plus 30 days of follow-up).

• Timing of CRS relative to the first dose of elranatamab

  From Cycle 1 Day 1 to 30 days after last dose of elranatamab, up to approximately 13 months (12 cycles, 28-day cycle length plus 30 days of follow-up).

• Incidence of ≥ Grade 3 infections

  Every cycle from Cycle 1 Day 1 to 30 days after last dose of elranatamab, up to approximately 13 months (12 cycles, 28-day cycle length plus 30 days of follow-up).

Study Arms (2)

Safety Lead-in (Cohort 1)

EXPERIMENTAL

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.

Drug: Elranatamab; Drug: Tocilizumab

Expansion (Cohort 2)

EXPERIMENTAL

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.

Drug: Elranatamab; Drug: Tocilizumab

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.

Also known as: Elrexfio

Expansion (Cohort 2); Safety Lead-in (Cohort 1)

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.

Also known as: Actemra

Expansion (Cohort 2); Safety Lead-in (Cohort 1)

Eligibility Criteria

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

You may qualify if:

• Written informed consent, according to institutional guidelines, signed and dated by the participant or by a legal guardian prior to the performance of any study-specific procedures, sampling, or analyses
• At least 18 years-of-age at the time of signature of the ICF
• Has documented diagnosis of MM according to IMWG diagnostic criteria
• Measurable disease at screening, as assessed by local laboratory, defined by any of the following:
• Serum M-protein level ≥0.5 g/dL
• Urine M-protein level ≥200 mg/24 hours
• Light chain MM without measurable M-protein in the serum or the urine: serum free light chain (sFLC) ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda FLC ratio
• For participants without measurable disease in the serum, urine, or involved FLC, presence of plasmacytomas (≥2 cm x 1 cm)
• Relapsed and/or refractory MM received ≥1 prior line of therapy and must have been exposed to both lenalidomide and an anti-CD38 monoclonal antibody (in the same or separate prior lines)
• ECOG Performance Status score of 0 or 1
• Human immunodeficiency virus (HIV)-positive participants are eligible if they meet all of the following:
• No detectable viral load (i.e., \<50 copies/mL) at screening
• CD4+ count \>300 cells/mm3 at screening
• No acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 6 months of screening
• Receiving highly active antiretroviral therapy (HAART). Any changes in HAART due to resistance/progression should occur at least 3 months prior to enrollment. A change in HAART due to toxicity is allowed up to 4 weeks prior to enrollment. HAART that could interfere with study treatment is excluded (consult the Medical Monitor for a review of medications prior to enrollment, if needed).

You may not qualify if:

• History of antitumor therapy as follows, before the first dose of study drug
• Targeted therapy, epigenetic therapy, or treatment with an investigational drug or used an invasive investigational medical device within 21 days or at least 5 half-lives, whichever is shorter.
• Monoclonal antibody treatment for MM within 21 days.
• Cytotoxic therapy within 21 days.
• PI therapy within 14 days.
• Immunomodulatory agent therapy within 7 days.
• Radiotherapy within 14 days or focal radiation within 7 days.
• Prior gene modified adoptive cell therapy (e.g., chimeric antigen receptor modified \[CAR\]-T cells) ≤12 weeks before the first dose of study drug
• Has received any of the following:
• Packed red blood cells within the last 7 days prior to dosing
• Platelet transfusions within the last 7 days prior to dosing
• Live vaccine within 1 month prior to screening or plans to receive a live vaccine during the study
• History of Grade ≥3 CRS or ICANS with prior therapies.
• Current treatment with strong or moderate inducers of cytochrome P450 (CYP) 3A4 (CYP3A4) that cannot be discontinued at least 7 days prior to the start of elranatamab treatment and during the study.
• Has myelodysplastic syndrome or active malignancies (i.e., progressing or requiring treatment change in the last 12 months) other than RRMM. The only allowed exceptions are:

Sponsors & Collaborators

• Pfizer: collaborator
• SCRI Development Innovations, LLC: lead

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

tocilizumab

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

Study Officials

• Hans Lee, MD

  Sarah Cannon Research Institute (SCRI) Oncology Partners

  STUDY CHAIR

Central Study Contacts

Sarah Cannon Development Innovations, LLC

CONTACT

615-329-7274; SCRI.InnovationsMedical@scri.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): February 1, 2030
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share