A Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in People With Relapsed Refractory Multiple Myeloma

NCT05675449 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: C1071020MAGNETISMM-20
• Study Type: interventional
• Target: 59
• Locations: 2 countries
• Sites: 36

Brief Summary

The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose.

Conditions

Multiple Myeloma

Keywords

elranatamab; relapsed; RRMM; BCMA; C1071020; MagnetisMM; maplipacelt; PF-06863135; carfilzomib; Bispecific antibody; PF-07901801; TTI-622; SIRPα; CD47

Outcome Measures

Primary Outcomes (3)

• Part 1 Number of participants with dose limiting toxicity (DLT)

  Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.

  From first dose of elranatamab through the end of the first cycle of combination treatment, about 42 days.

• Part 2A Number of participants with dose limiting toxicity

  Dose limiting toxicity based on dose limiting toxicity evaluable participants.

  From the first dose of maplirpacept through the first cycle of combination treatment, about 64 days.

• Part 2B Number of participants with dose limiting Toxicity

  Dose limiting toxicity rate based on dose limiting toxicity evaluable participants.

  From first dose of elranatamab through the first cycle of combination treatment, about 42 days.

Secondary Outcomes (47)

• Part 1: Number of Participants with Treatment Emergent Adverse Events (TEAE) by Seriousness and Relationship to Treatment

  Assessed from baseline up to 90 days after last dose of study treatment.

• Part 1: Number of Participants with Adverse Events (AE) characterized by type, frequency, severity.

  Assessed from baseline up to 90 days after last dose of study treatment.

• Part 1: Number of Participants with Clinically Significant Change From Baseline in Laboratory Abnormalities

  Accessed from baseline up to 90 days after the last dose of study treatment.

• Part 1: Percent of participants with Best Overall Response (BOR)

  Assessed for approximately 2 years

• Part 1: Percentage of Participants with an Objective Response Rate (ORR)

  Assessed from enrollment for approximately 2 years.

Study Arms (3)

Part 1 Dose Escalation

EXPERIMENTAL

Non randomized Elranatamab plus Carfilzomib and Dexamethasone

Drug: Elranatamab; Drug: Carfilzomib

Part 2A Dose Escalation

EXPERIMENTAL

Non randomized Elranatamab plus Maplirpacept

Drug: Elranatamab; Drug: Maplirpacept

Part 2B Dose Randomization

EXPERIMENTAL

Randomized dose level Elranatamab plus Maplirpacept

Drug: Elranatamab; Drug: Maplirpacept

Interventions

Elranatamab DRUG

BCMA-CD3 bispecific antibody

Also known as: PF-06863135

Part 1 Dose Escalation; Part 2A Dose Escalation; Part 2B Dose Randomization

Carfilzomib DRUG

proteasome inhibitor

Also known as: Kyprolis

Part 1 Dose Escalation

Maplirpacept DRUG

CD47-SIRP alpha-directed

Also known as: PF-07901801, TTI-622

Part 2A Dose Escalation; Part 2B Dose Randomization

Eligibility Criteria

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

You may qualify if:

• Prior diagnosis of multiple myeloma as defined by IMWG criteria.
• Measurable disease based on IMWG criteria as defined by at least 1 of the following:
• Serum M-protein ≥0.5 g/dL.
• Urinary M-protein excretion ≥200 mg/24 hours.
• Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
• Part 1: Received at least 1 but not more than 3 prior lines of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as 1 line of therapy).
• Part 2: Received at least 3 prior lines of therapy for multiple myeloma who are refractory to at least one IMiD, one PI and one anti-CD38 antibody.
• ECOG performance status 0-1.
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
• Not pregnant or breastfeeding and willing to use contraception.

You may not qualify if:

• Plasma cell leukemia, Smouldering MM, Waldenströms macroglobulinemia, Amyloidosis, POEMS Syndrome, Primary refractory MM
• Impaired cardiovascular function or clinically significant cardiovascular diseases.
• Participants with any active, uncontrolled bacterial, fungal, or viral infection.
• Stem cell transplant within 12 weeks prior to enrollment, or active graft versus host disease.
• 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.
• Part 1: Previous treatment with a BCMA-directed therapy.
• Part 2: Previous treatment with any anti-BCMA directed therapy, with the exception of CAR-T. Previous treatment with a CD47-SIRP alpha-directed therapy.
• Part 1: Prior treatment with carfilzomib
• Live attenuated vaccine within 4 weeks of the first dose of study intervention.
• Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
• Any of the following within 3 months of enrollment: erosive esophagitis, treatment resistant peptic ulcer, infectious or inflammatory bowel disease, pulmonary embolism or uncontrolled thromboembolic event.
• Intolerance to or participants who have had a severe (Grade ≥3) allergic or anaphylactic reaction to antibodies or therapeutic proteins

Sponsors & Collaborators

• Pfizer: lead

Study Sites (36)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

Clinical Research Advisors (Encino Satellite Location)

Encino, California, 91316, United States

Location

Clinical Research Advisors (Korea Town Satellite Location)

Los Angeles, California, 90020, United States

Location

Clinical Research Advisors (West Hollywood Satellite Location)

Los Angeles, California, 90048, United States

Location

Sylvester Comprehensive Cancer Center - Aventura

Aventura, Florida, 33180, United States

Location

Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center

Coral Gables, Florida, 33146, United States

Location

Sylvester Comprehensive Cancer Center - Coral Springs

Coral Springs, Florida, 33065, United States

Location

University of Miami Hospital and Clinics - Deerfield Beach

Deerfield Beach, Florida, 33442, United States

Location

Sylvester Comprehensive Cancer Center - Hollywood

Hollywood, Florida, 33021, United States

Location

Griffin Cancer Research Building (GCRB)

Miami, Florida, 33136, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

University of Miami Hospital and Clinics

Miami, Florida, 33136, United States

Location

Sylvester Comprehensive Cancer Center - Kendall

Miami, Florida, 33176, United States

Location

Sylvester Comprehensive Cancer Center - Plantation

Plantation, Florida, 33324, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Administration Office

Atlanta, Georgia, 30322, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

State University of Iowa, Division of Sponsored Programs

Iowa City, Iowa, 52242, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Oncology Investigational Drug Service,Department of Pharmacy Services

Baltimore, Maryland, 21231, United States

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231, United States

Location

Johns Hopkins University Cancer Immunology/GI Oncology

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana Farber/Mass General Brigham Cancer Care, Inc

Boston, Massachusetts, 02115, United States

Location

MSK Monmouth

Middletown, New Jersey, 07748, 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 - Main Campus

New York, New York, 10065, United States

Location

Henry-Joyce Cancer Clinic

Nashville, Tennessee, 37232, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Division of Hematology Hadassah Medical Center - Ein Kerem

Jerusalem, 9112001, Israel

Location

The Research Fund of Hadassah Medical Organization (R.A.)

Jerusalem, 9112001, Israel

Location

Hematology Division Davidoff Center, Rabin Medical Center, Beilinson Hospital

Petah Tikva, 4941492, Israel

Location

Rabin Medical Center

Petah Tikva, 4941492, Israel

Location

Related Links

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

MeSH Terms

Conditions

Multiple Myeloma; Recurrence

Interventions

carfilzomib

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

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 9, 2023
• Study Start: December 14, 2022
• Primary Completion: July 7, 2025
• Study Completion (Estimated): February 29, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (5); US (31)