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

NCT05014412 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: C1071009MagnetisMM-9
• Study Type: interventional
• Target: 86
• Locations: 4 countries
• Sites: 50

Brief Summary

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.

Conditions

Multiple Myeloma

Keywords

BCMA; Multiple Myeloma; Relapse/Refractory; RRMM; Elranatamab; Targeted T-cell; MagnetisMM; MM9; Phase 2; B-Cell Maturation Antigen; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Grade 2 or Higher Cytokine Release Syndrome (CRS) During Cycle 1: Parts 1 and 2

  CRS: supraphysiologic response following any immune therapy that results in the activation or engagement of endogenous or infused T-cells and/or other immune effector cells. Symptoms must include fever at the onset, and may include hypotension, hypoxia and end organ dysfunction. As per ASTCT criteria, Grade (G) 1: fever (temperature \>=38 degree Celsius), hypotension and/or hypoxia none; G 2: fever, hypotension not requiring vasopressors, hypoxia requiring low-flow nasal cannula/ facemask or blow-by; G 3: fever, hypotension requiring a vasopressor with or without vasopressin, hypoxia requiring high-flow nasal cannula/ facemask, nonrebreather mask, or Venturi mask; G 4: fever, hypotension requiring multiple vasopressors (excluding vasopressin), hypoxia requiring positive pressure. Organ toxicities associated with CRS graded according to CTCAE v5.0. G 1: Mild, G 2: Moderate, G 3: severe, and G 4: life-threatening consequences; urgent intervention indicated. G 5: death related to AE.

  Parts 1 and 2: Cycle 1 (28 days)

Secondary Outcomes (17)

• Number of Participants With Dose Limiting Toxicities (DLTs): Part 2A

  Part 2A: 28 days starting from the first 116 or 152 mg dose

• Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [All Causalities and Treatment Related]: Parts 1 and 2

  Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)

• Number of Participants With Maximum Grade 3 or 4 and Grade 5 AEs [All Causalities and Treatment Related] Per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5: Parts 1 and 2

  Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)

• Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2

  Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)

• Number of Participants With Hematological Measures With Baseline CTCAE Grade >=2 Shifted to a Maximum CTCAE Grade 3-4: Parts 1 and 2

  Parts 1 and 2: From start of treatment to end of the study (approximately 3 years 7 months)

Study Arms (4)

Part 1

EXPERIMENTAL

Evaluation of step-up priming dosing

Drug: Elranatamab

Part 2A

EXPERIMENTAL

Dose determination

Drug: Elranatamab

Part 2B

EXPERIMENTAL

Dose expansion

Drug: Elranatamab

Part 2C

EXPERIMENTAL

To explore higher dose intensity

Drug: Elranatamab

Interventions

Elranatamab DRUG

BCMA-CD3 bispecific antibody

Part 1; Part 2A; Part 2B; Part 2C

Eligibility Criteria

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

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (50)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Poudre Valley Hospital

Fort Collins, Colorado, 80524, United States

Location

Cancer Care & Hematology - Fort Collins

Fort Collins, Colorado, 80528, United States

Location

Poudre Valley Health System (PVHS)

Fort Collins, Colorado, 80528, United States

Location

UCHealth Cancer Care & Hematology - Greeley

Greeley, Colorado, 80634, United States

Location

UCHealth Cancer Care & Hematology - Loveland

Loveland, Colorado, 80538, United States

Location

UF Health Shands Cancer Hospital

Gainesville, Florida, 32608, United States

Location

UF Health Shands Hospital Pharmacy Investigational Drug Service - Main

Gainesville, Florida, 32610, United States

Location

UF Health Shands Hospital

Gainesville, Florida, 32610, United States

Location

East Jefferson General Hospital Bone Marrow Transplant Clinic

Metairie, Louisiana, 70006, United States

Location

East Jefferson General Hospital

Metairie, Louisiana, 70006, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

The Regents of the University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

MSK Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

MSK Monmouth

Middletown, New Jersey, 07748, United States

Location

MSK Bergen

Montvale, New Jersey, 07645, United States

Location

MSK Commack

Commack, New York, 11725, United States

Location

MSK Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy

Long Island City, New York, 11101, United States

Location

Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

New York, New York, 10021, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MSK Nassau

Uniondale, New York, 11553, United States

Location

Cleveland Clinic Taussig Cancer Institute

Cleveland, Ohio, 44195, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

Texas Oncology-South Austin

Austin, Texas, 78745, United States

Location

Blood Cancer and Stem Cell Transplant Clinic

San Antonio, Texas, 78229, United States

Location

Methodist Healthcare System of San Antonio dba Methodist Hospital

San Antonio, Texas, 78229, United States

Location

Methodist Hospital Investigational Pharmacy

San Antonio, Texas, 78229, United States

Location

Methodist Plaza Clinical Trials Office

San Antonio, Texas, 78229, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Nagoya City University Hospital

Nagoya, Aichi-ken, 467-8602, Japan

Location

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo, 150-8935, Japan

Location

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2TH, United Kingdom

Location

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, SE1 9RT, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

University College London Hospitals NHS Foundation Trust NIHR

London, W1T 7HA, United Kingdom

Location

The Royal Marsden NHS Foundation Trust

Surrey, SM2 5PT, United Kingdom

Location

Related Publications (2)

• Lon HK, Hibma J, Jiang S, Sullivan S, Vandendries E, Skoura A, Wang D, Elmeliegy M. Population Exposure-Response Efficacy Analysis of Elranatamab (PF-06863135) in Patients with Multiple Myeloma. Target Oncol. 2025 Sep;20(5):803-819. doi: 10.1007/s11523-025-01168-y. Epub 2025 Aug 18.

  PMID: 40826257 DERIVED

• Elmeliegy M, Viqueira A, Vandendries E, Hickman A, Conte U, Irby D, Hibma J, Lon HK, Piscitelli J, Soltantabar P, Skoura A, Jiang S, Wang D. Dose Optimization of Elranatamab to Mitigate the Risk of Cytokine Release Syndrome in Patients with Multiple Myeloma. Target Oncol. 2025 Mar;20(2):349-359. doi: 10.1007/s11523-025-01134-8. Epub 2025 Feb 25.

  PMID: 40000533 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

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

Limitations and Caveats

ASTCT: American Society for Transplantation and Cellular Therapy. CTCAE: Common Terminology Criteria for Adverse Events. g/dl: Gram/deciliter mg: Milligram BM: Bone marrow Cm: Centimeter SPD: Sum of the products of diameters mcl: Microliter

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 20, 2021
• Study Start: October 7, 2021
• Primary Completion: June 15, 2023
• Study Completion: December 12, 2025
• Last Updated: February 10, 2026
• Results First Posted: July 30, 2024

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (7); US (35); JP (5); TW (3)