A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of the study (Part 1 and Part 2) is to evaluate the safety of a step-up dosing approach (starting with low doses followed by higher doses) of the study medicine (elranatamab) in participants with multiple myeloma that has come back after responding to treatment or has not responded to treatment (relapsed/refractory multiple myeloma). This study will also look at the safety and efficacy of different doses of elranatamab, as well as different intervals between doses. Participants in the study will receive elranatamab as an injection under the skin at the study clinic. After the initial step-up doses, participants will start receiving one dose every week. The frequency of clinic visits for injections may then decrease over time. Participation will be at least two years.

Key facts

Study ID

NCT05014412

Run by

Pfizer

People needed

86

Starts

2021-10-07

Expected to finish

2025-12-12

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of multiple myeloma (IMWG criteria, Rajkumar et al, 2014)
• Measurable disease, as defined by at least 1 of the following:
• Serum M-protein >0.5 g/dL by SPEP
• Urinary M-protein excretion >200 mg/24 hours by UPEP
• Serum immunoglobulin FLC≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio
• Refractory to at least one IMiD
• Refractory to at least one PI
• Refractory to at least one anti-CD38 antibody
• Relapsed/refractory to last anti-myeloma regimen
• ECOG performance status ≤1
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1
• Not pregnant and willing to use contraception

You may not qualify if…

• Smoldering multiple myeloma
• Active Plasma cell leukemia
• POEMS syndrome
• Amyloidosis
• Waldenström's macroglobulinemia
• Known active CNS involvement or clinical signs of myelomatous meningeal involvement
• Stem cell transplant within 12 weeks prior to enrollment or active GVHD
• Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection
• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ or Stage 0/1 malignancy with minimal risk of recurrence per investigator.
• Previous treatment with an anti-BCMA bispecific antibody or CAR-T cell therapy.
• Live attenuated vaccine within 4 weeks of the first dose
• Previous administration with an investigational drug within 30 days or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)
• Known or suspected hypersensitivity to the study intervention, or any of its excipients

Where it is running

• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Mayo Clinic — Scottsdale, Arizona, United States
• Poudre Valley Hospital — Fort Collins, Colorado, United States
• Cancer Care & Hematology - Fort Collins — Fort Collins, Colorado, United States
• Poudre Valley Health System (PVHS) — Fort Collins, Colorado, United States
• UCHealth Cancer Care & Hematology - Greeley — Greeley, Colorado, United States
• UCHealth Cancer Care & Hematology - Loveland — Loveland, Colorado, United States
• UF Health Shands Cancer Hospital — Gainesville, Florida, United States
• UF Health Shands Hospital Pharmacy Investigational Drug Service - Main — Gainesville, Florida, United States
• UF Health Shands Hospital — Gainesville, Florida, United States
• East Jefferson General Hospital Bone Marrow Transplant Clinic — Metairie, Louisiana, United States
• East Jefferson General Hospital — Metairie, Louisiana, United States
• Tulane University — New Orleans, Louisiana, United States
• The Regents of the University of Michigan — Ann Arbor, Michigan, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• MSK Basking Ridge — Basking Ridge, New Jersey, United States
• MSK Monmouth — Middletown, New Jersey, United States
• MSK Bergen — Montvale, New Jersey, United States
• MSK Commack — Commack, New York, United States
• MSK Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy — Long Island City, New York, United States
• Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• MSK Nassau — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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